{ "metadata": { "query": "Glioblastoma OR Glioblastoma Multiforme", "filter": "Interventional studies only", "fetch_date": "2026-01-22T18:29:44.842362", "total_trials": 1913, "source": "ClinicalTrials.gov API v2", "processing_date": "2026-01-22T18:40:36", "processing_step": "03_data_preprocessing", "statistics": { "total_trials": 1913, "modality_distribution": { "Device/Procedure": 1132, "Small Molecule": 1002, "Immunotherapy": 682, "Other": 310, "Viral/Gene Therapy": 97 }, "moa_target_distribution": { "MET": 363, "VEGF": 200, "PD-1": 100, "MGMT": 63, "EGFR": 61, "mTOR": 42, "IDH": 37, "PD-L1": 25, "PARP": 23, "CTLA-4": 20, "ALK": 19, "CDK": 17, "TERT": 8, "BRAF": 7, "MEK": 7, "PI3K": 6 }, "moa_class_distribution": { "Alkylating agent": 642, "Angiogenesis inhibitor": 194, "Kinase inhibitor": 159, "Checkpoint inhibitor": 34, "Cell cycle inhibitor": 23, "DNA repair inhibitor": 16, "Epigenetic modifier": 9 }, "status_distribution": { "COMPLETED": 904, "RECRUITING": 274, "TERMINATED": 247, "UNKNOWN": 172, "ACTIVE_NOT_RECRUITING": 154, "WITHDRAWN": 82, "NOT_YET_RECRUITING": 59, "SUSPENDED": 15, "ENROLLING_BY_INVITATION": 6 }, "phase_distribution": { "PHASE2": 927, "PHASE1": 860, "NA": 227, "PHASE3": 115, "EARLY_PHASE1": 82, "PHASE4": 7 } } }, "trials": [ { "NCTId": "NCT02765165", "BriefTitle": "Phase 1/2 Study of USL311 +/- Lomustine in Advanced Solid Tumors or Relapsed/Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase 1/2 Dose-escalation of USL311 as Single Agent and in Combination With Lomustine (CCNU) in Subjects With Advanced Solid Tumors, With Subsequent Single Agent and Combination Phase 2 Cohorts for Subjects With Relapsed/Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-04", "PrimaryCompletionDate": "2020-07-01", "Interventions": [ { "Name": "USL311", "Type": "DRUG", "Description": "Administered once weekly in a 21-day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "USL311", "Type": "DRUG", "Description": "Administered once daily in a 21-day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "USL311", "Type": "DRUG", "Description": "Administered once daily in a 42-day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Administered once every 6 weeks in a 42-day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Proximagen, LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00613028", "BriefTitle": "Ph II Bev + Either Temozolomide/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan", "OfficialTitle": "Phase II Study of Bevacizumab Plus Either Temozolomide or Etoposide for (GBM) Patients Who Have Failed Bevacizumab Plus Irinotecan", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-04", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "Temo + Avastin", "Type": "DRUG", "Description": "Patients have progressed/had gr3/\\> toxicity related to etoposide, with no had progression/gr 3/\\> toxicity related to temozolomide, will only be considered for bevacizumab and temozolomide. Bevacizumab intravenously at dose 10mg/kg every other wk. For patients on bevacizumab and temozolomide, temozolomide administered on continuous dosing schedule at 50mg/m2/day.", "OtherNames": [ "temozolomide", "temodar", "bevacizumab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "VP-16 + Avastin", "Type": "DRUG", "Description": "Patients have progressed/had gr3/\\> toxicity related to temozolomide, but have not progressed/gr3/\\> toxicity related to etoposide,considered only for bevacizumab and etoposide. Bevacizumab intravenously at dose 10mg/kg every other wk. Patients on bevacizumab and etoposide, etoposide once daily at 50mg/m2/day first 21 days of each 28-day cycle.", "OtherNames": [ "VP-16", "etoposide", "bevacizumab", "avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT07138001", "BriefTitle": "Phase 2 Clinical Trial of KH617", "OfficialTitle": "A Randomized, Controlled, Open-label, Multicenter Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH617 in Combination With Temozolomide Versus Investigator's Choice Treatment or KH617 Monotherapy for Recurrent Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-08", "PrimaryCompletionDate": "2027-09", "Interventions": [ { "Name": "KH617+TMZ", "Type": "COMBINATION_PRODUCT", "Description": "use KH617 and TMZ(5/28) as Combination Product.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "KH617", "Type": "DRUG", "Description": "Single Clinical trial investigational drug", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16", "Type": "DRUG", "Description": "Comparator product, Two treatment options for physicians and subjects to choose from:\n\n1. use TMZ(7/7)\n2. Use Platinum (cisplatin or carboplatin)+VP-16", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sichuan Honghe Biotechnology Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00050986", "BriefTitle": "Phase I/II Evaluation of Temozolomide and ZARNESTRA (R115777) for Recurrent and Progressive Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Evaluation Temozolomide and Farnesyl Transferase Inhibitor ZARNESTRA (R115777) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-12", "PrimaryCompletionDate": "2008-10", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Starting Dose Level: 100 mg/m\\^2 taken by mouth once daily for 7 days, followed by 7 days rest and another 7-day dosing period and 7-day rest period.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "R115777", "Type": "DRUG", "Description": "Starting Dose Level: 400 mg taken by mouth for 7 consecutive days every other week on alternating weeks (days 8-14 and 22-28) every 4 weeks.", "OtherNames": [ "Zarnestra" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Johnson & Johnson" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03243461", "BriefTitle": "International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)", "OfficialTitle": "International Cooperative Phase III Trial of the HIT-HGG Study Group for the Treatment of High Grade Glioma, Diffuse Intrinsic Pontine Glioma, and Gliomatosis Cerebri in Children and Adolescents < 18 Years.(HIT-HGG-2013)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2018-07-17", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Temozolomide + Valproic Acid", "Type": "DRUG", "Description": "Valproic acid additionally to simultaneous radiochemotherapy with temozolomide", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Göttingen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Deutsche Kinderkrebsstiftung", "Hannover Medical School" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00486603", "BriefTitle": "Hydroxychloroquine, Radiation, and Temozolomide Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Trial of Hydroxychloroquine in Conjunction With Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-10-29", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "hydroxychloroquine", "Type": "DRUG", "Description": "see arm description, the first 10 week cycle is call initiation cycle, Post the 10 week cycle of just HCQ, 4 week cycles are called Maintenance Cycles", "OtherNames": [ "Plaquenil", "HCQ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "TMZ daily 75mg/m2 for 6wks with RT+HCQ (TMZ is given only during Initiation cycle)", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Seven samples in total will be collected baseline, initiation cycle -week3-4, week9-10, Maintenance Cycle 1 Week 4 (C1W4), Cycle2 Week4, Cycle3 Week4, Cycle6 Week4", "OtherNames": [ "PK", "correlative studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Radiation during the first six weeks of treatment Monday-Friday", "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04757662", "BriefTitle": "Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma", "OfficialTitle": "A Phase IB Study to Use Tadalafil to Overcome Immunosuppression During Chemoradiotherapy for IDH-wildtype Grade III-IV Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2021-05-14", "PrimaryCompletionDate": "2023-06-07", "Interventions": [ { "Name": "Tadalafil", "Type": "DRUG", "Description": "Tadalafil is commercially available and will be purchased by the Siteman Cancer Center and distributed to participants free of charge.", "OtherNames": [ "Cialis", "Adcirca" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT07285044", "BriefTitle": "The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas", "OfficialTitle": "Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-12-18", "PrimaryCompletionDate": "2026-12-18", "Interventions": [ { "Name": "Cancer Therapeutic Procedure", "Type": "DRUG", "Description": "Receive in-home standard of care cancer-treatment", "OtherNames": [ "anticancer therapy", "Cancer Therapy", "Cancer Treatment", "Malignant Neoplasm Therapy", "Malignant Neoplasm Treatment" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cancer Therapeutic Procedure", "Type": "DRUG", "Description": "Receive in-clinic standard of care cancer-treatment", "OtherNames": [ "anticancer therapy", "Cancer Therapy", "Cancer Treatment", "Malignant Neoplasm Therapy", "Malignant Neoplasm Treatment" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03911388", "BriefTitle": "HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors", "OfficialTitle": "Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-09-12", "PrimaryCompletionDate": "2026-09-01", "Interventions": [ { "Name": "G207", "Type": "BIOLOGICAL", "Description": "Single dose of G207 infused through catheters into region(s) of tumor. If G207 is safe in the first cohort of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor followed by a 5 Gy dose of radiation to the tumor (which includes progressive leptomeningeal disease or any site of gross tumor progressing in the brain parenchyma) within 24 hours of virus inoculation.", "OtherNames": [ "HSV G207" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cannonball Kids' Cancer Foundation", "Treovir, Inc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03451799", "BriefTitle": "Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Glioblastoma", "OfficialTitle": "IIT2016-17-HU-KETORADTMZ: A Phase 1 Study of a 4-month Ketogenic Diet in Combination With Standard-of-care Radiation and Temozolomide for Patients With Newly/Recently Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-04-13", "PrimaryCompletionDate": "2021-09-03", "Interventions": [ { "Name": "Ketogenic Diet", "Type": "OTHER", "Description": "A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard-of-care radiation", "Type": "RADIATION", "Description": "Patients will receive standard-of-care radiation. Radiation is not protocol directed.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard-of-care Temozolomide", "Type": "DRUG", "Description": "Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jethro Hu", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00906893", "BriefTitle": "Evaluation of [18F]-FMISO for Non Operated Glioblastoma", "OfficialTitle": "Methodological Evaluation of Fluor 18 Labelled Fluoromisonidazole ([18F]-FMISO) Positon Emission Tomography-Computed Tomography (PET-CT) for Non Operated Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "18F]-FMISO PET-CT", "Type": "PROCEDURE", "Description": "pretherapy(\\[18F\\]-FMISO) positon emission tomography-computed tomography. Different acquisition protocols will be tested and a wild panel of quantification parameters issued from published studies and original ones developed by our team enable to describe \\[18F\\]-FMISO uptake will be used.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Bordeaux", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04277221", "BriefTitle": "ADCTA for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "Autologous Dendritic Cell / Tumor Antigen (ADCTA-SSI-G1) for Adjuvant Immunotherapy in Standard Treatment of Recurrent Glioblastoma Multiforme (GBM): A Multi-center, Open-label, Randomized Phase III Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2019-09-19", "PrimaryCompletionDate": "2022-12-31", "Interventions": [ { "Name": "Autologous Dendritic Cell/Tumor Antigen, ADCTA", "Type": "BIOLOGICAL", "Description": "ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Safe Save Medical Cell Sciences & Technology Co.,Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04065087", "BriefTitle": "Efficacy and Safety Study of GX-I7 Plus Adjuvant Temozolomide Combination in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 1/2, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability, Anti-tumor Activity of GX-I7 Plus Adjuvant Temozolomide Combination Regimen in Patients With Newly Diagnosed With Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-08-22", "PrimaryCompletionDate": "2022-05-27", "Interventions": [ { "Name": "GX-I7", "Type": "BIOLOGICAL", "Description": "Investigational drug", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "Placebo drug", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Genexine, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01902771", "BriefTitle": "Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors", "OfficialTitle": "A Phase I Study of Dendritic Cell Vaccine Therapy With In Situ Maturation for Pediatric Brain Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2013-09-03", "PrimaryCompletionDate": "2016-10-24", "Interventions": [ { "Name": "Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "Post-Leukapheresis. Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.", "OtherNames": [ "DC Vaccine" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor Lysate", "Type": "BIOLOGICAL", "Description": "Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.", "OtherNames": [ "Tumor Cell Lysate", "Lysate of Tumor" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Imiquimod", "Type": "OTHER", "Description": "Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol.", "OtherNames": [ "Aldara" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Leukapheresis", "Type": "PROCEDURE", "Description": "Baseline, post-surgery. Subjects will undergo leukapheresis procedure during baseline, after recovery from surgery to collect peripheral blood mononuclear cells (PBMCs) from which dendritic cells will be obtained, per study protocol.", "OtherNames": [ "Pheresis" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Edward Ziga", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02966509", "BriefTitle": "Engagement of Patients With Advanced Cancer", "OfficialTitle": "Engagement of Patients With Advanced Cancer", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-08", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "EPAC", "Type": "BEHAVIORAL", "Description": "Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [ "VA Palo Alto Health Care System" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01856933", "BriefTitle": "BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)", "OfficialTitle": "BrUOG 263: PSMA ADC for Recurrent Glioblastoma Multiforme (GBM): A Phase II Brown University Oncology Research Group Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2014-11", "Interventions": [ { "Name": "PSMA ADC", "Type": "DRUG", "Description": "2.5 mg/kg, IV, over 60 minutes every 3 weeks", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Heinrich Elinzano, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Progenics Pharmaceuticals, Inc.", "Rhode Island Hospital", "University of Texas" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02663440", "BriefTitle": "Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": null, "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2016-01", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Hypofractionated IMRT", "Type": "RADIATION", "Description": "Hypofractionated IMRT", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Granulocyte-macrophage Colony-stimulating Factor", "Type": "BIOLOGICAL", "Description": "Granulocyte-macrophage Colony-stimulating Factor", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Zhejiang Cancer Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00045474", "BriefTitle": "Brachytherapy in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-10", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 125", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00032097", "BriefTitle": "Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain", "OfficialTitle": "A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-04", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01076530", "BriefTitle": "Vorinostat and Temozolomide in Treating Young Patients With Relapsed or Refractory Primary Brain Tumors or Spinal Cord Tumors", "OfficialTitle": "A Phase I Study of SAHA and Temozolomide in Children With Relapsed or Refractory Primary Brain or Spinal Cord Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-02", "PrimaryCompletionDate": "2012-10", "Interventions": [ { "Name": "vorinostat", "Type": "DRUG", "Description": null, "OtherNames": [ "L-001079038", "SAHA", "suberoylanilide hydroxamic acid", "Zolinza" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "diagnostic laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06975332", "BriefTitle": "Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression", "OfficialTitle": "Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy in Glioma (WHO G3-G4) Progression", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-10-09", "PrimaryCompletionDate": "2026-09", "Interventions": [ { "Name": "Local, targeted therapy with alpha emitter [225Ac]Ac-DOTA-SP (TAT)", "Type": "RADIATION", "Description": "Local, targeted therapy with alpha emitter \\[225Ac\\]Ac-DOTA-SP (TAT) administered to the post-resection cavity or tumour via Rickham reservoir using induced diffusion.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical University of Warsaw", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02758366", "BriefTitle": "Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma", "OfficialTitle": "An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme (GBM) and Diffuse Intrinsic Pontine Glioma (DIPG)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2016-02", "PrimaryCompletionDate": "2020-01-16", "Interventions": [ { "Name": "Doxorubicin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Meyer Children's Hospital IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02286167", "BriefTitle": "Glioma Modified Atkins-based Diet in Patients With Glioblastoma", "OfficialTitle": "The Feasibility and Biologic Effect of a Modified Atkins-based Intermittent Fasting Diet in Patients With Glioblastoma (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2014-11", "PrimaryCompletionDate": "2019-01-03", "Interventions": [ { "Name": "Diet modification", "Type": "OTHER", "Description": "All patients will be participate in the intermittent, modified Atkins diet", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02395692", "BriefTitle": "Methoxyamine and Temozolomide in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase II Study of TRC102 in Combination With Temozolomide for Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-12-18", "PrimaryCompletionDate": "2017-02-16", "Interventions": [ { "Name": "Treatment", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Methoxyamine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "TRC102" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03722342", "BriefTitle": "TTAC-0001 and Pembrolizumab Combination phase1b Trial in Recurrent Glioblastoma", "OfficialTitle": "A Phase 1b, Open-Label, Safety and Tolerability Study of TTAC-0001 in Combination With Pembrolizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2019-01-16", "PrimaryCompletionDate": "2019-11-04", "Interventions": [ { "Name": "TTAC-0001 and pembrolizumab combination", "Type": "DRUG", "Description": "* Investigational product (IP): TTAC-0001 and Pembrolizumab (Merck, Keytruda®)\n* Treatment groups: 3 dose levels\n\n * Dose level 1 (optimal starting dose): TTAC-0001 12 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1\n * Dose level 2 (first escalation dose): TTAC-0001 16 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1\n * Dose level 0 (de-escalation dose): TTAC-0001 8 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1\n* Cycle: 3 weeks (21 days per cycle)", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "PharmAbcine", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT05607407", "BriefTitle": "Methimazole in Patients With Progressive Glioblastoma", "OfficialTitle": "Targeting Transsulfuration Via Suppression of Thyroid Hormone Signaling in Progressive Glioblastoma: Phase 2 and Pharmacodynamic Trial of Methimazole in Patients With Progressive Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-01-30", "PrimaryCompletionDate": "2026-01", "Interventions": [ { "Name": "Methimazole", "Type": "DRUG", "Description": "Starting dose: Methimazole 15 mg/d. Six participants will receive this dose. If they achieve a 10% increase in peripheral blood H2S concentrations, an additional 13 participants will receive this dose to accrue a total of 19 participants for which a preliminary estimate of PFS6 can be calculated. If the first 6 participants do not achieve a 10% increase in peripheral blood H2S concentrations, the dose will be increased to the second and final dose level of 25 mg/d at which 19 participants will be treated.", "OtherNames": [ "Northyx", "Tapazole" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Recurrent Glioblastoma Surgical Resection", "Type": "PROCEDURE", "Description": "The purpose of resection is to remove as much tumor as possible to alleviate mass effect and to obtain brain tissue for experimental analysis.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Pharmacodynamic Assays", "Type": "DIAGNOSTIC_TEST", "Description": "Pharmacodynamic assays are intended to investigate drug and downstream drug-induced effects.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02047214", "BriefTitle": "Safety & Efficacy Study of TPI 287 + Avastin in Adults With Glioblastoma That Progressed Following Prior Avastin Therapy", "OfficialTitle": "Phase 2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab in Adults With Recurrent or Progressive Glioblastoma Following a Bevacizumab-Containing Regimen", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "TPI 287", "Type": "DRUG", "Description": "TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.", "OtherNames": [ "TPI-287", "NBT 287" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Cortice Biosciences, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02202993", "BriefTitle": "TAU-2014-1: Mibefradil and Hypofractionated Re-Irradiation Therapy in Recurrent GBM", "OfficialTitle": "TAU-2014-1: Phase I Trial of Mibefradil Dihydrochloride With Hypofractionated Re-Irradiation Therapy in Treating Patients With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-08", "PrimaryCompletionDate": "2017-09-29", "Interventions": [ { "Name": "Mibefradil with Radiation", "Type": "DRUG", "Description": "Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD.\n\nThis will be given concurrently with hypofractionated radiation therapy.", "OtherNames": [ "mibefradil", "mibefradil dihydrochloride", "Posicor", "hypo fractionated radiation", "intensity modulated radiation", "IMRT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cavion, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Yale University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04765514", "BriefTitle": "Chemoradiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail GBM Patients", "OfficialTitle": "A Randomized Controlled Trial of Chemo-Radiotherapy Versus Biomarker-Guided Therapy for Elderly and Frail Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-07-27", "PrimaryCompletionDate": "2032-06", "Interventions": [ { "Name": "Biomarker based treatment (Temozolomide monotherapy or Radiotherapy monotherapy)", "Type": "OTHER", "Description": "Temozolomide or Radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Chemo-Radiotherapy consisting of 40 Gy in 15 daily fractions with concurrent temozolomide.", "Type": "COMBINATION_PRODUCT", "Description": "Temozolomide will be administered at a dose of 75 mg/m2 daily for a total of 21 days. This will be followed by adjuvant temozolomide (150-200 mg/m2 daily for 5 day", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05686798", "BriefTitle": "Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.", "OfficialTitle": "Phase I Study of Replication-Competent Adenovirus-Mediated Double Suicide Gene Therapy With Stereotactic Radiosurgery in Patients With Recurrent or Progressive High Grade Astrocytomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-11-29", "PrimaryCompletionDate": "2027-01", "Interventions": [ { "Name": "Ad5-yCD/mutTKSR39rep-ADP adenovirus and fractionated stereotactic radiosurgery (fSRS)", "Type": "BIOLOGICAL", "Description": "Ad5-yCD/mutTKSR39rep-ADP adenovirus will be injected intratumoral", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Henry Ford Health System", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02046187", "BriefTitle": "Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Prospective Trial for Newly Diagnosed GBM, With Upfront Gross or Subtotal Resection, Followed by Ketogenic Diet With Radiotherapy and Concurrent Temodar(R) Chemotherapy Followed by Adjuvant Temodar(R) Chemotherapy.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-10", "PrimaryCompletionDate": "2017-02", "Interventions": [ { "Name": "Ketogenic Diet", "Type": "DIETARY_SUPPLEMENT", "Description": "Patients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Patients receive standard dose (60Gy/30 fractions) external beam radiation", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "patients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.", "OtherNames": [ "Temodar(R)", "chemotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT05781321", "BriefTitle": "Short Course Radiotherapy for the Treatment of Patients With Glioblastoma, SAGA Study", "OfficialTitle": "Stereotactic Accelerated Radiotherapy in GlioblastomA (SAGA)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-03-23", "PrimaryCompletionDate": "2026-07-02", "Interventions": [ { "Name": "Accelerated Hypofractionated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo short course RT", "OtherNames": [ "AHF-RT", "AHRT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT simulation", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized Tomography", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Fluorodopa F 18", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "(18F)FDOPA", "18F-DOPA", "18F-FDOPA", "3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine", "6-(18F)Fluoro-L-DOPA", "Fluorine F 18 Fluorodopa", "Fluorine-18-fluoro-L-DOPA", "Fluorodopa (18F)", "FLUORODOPA F-18", "L-6-(18F)Fluoro-DOPA" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "PT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Complete questionnaires", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo standard course RT", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02709616", "BriefTitle": "Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)", "OfficialTitle": "Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-03-01", "PrimaryCompletionDate": "2017-10-31", "Interventions": [ { "Name": "Personalized cellular vaccine", "Type": "BIOLOGICAL", "Description": "Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.", "OtherNames": [ "Tumor antigen pulsed DC vaccine" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Guangdong 999 Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Jinan University Guangzhou", "Beijing Tricision Biotherapeutics Inc", "Zhuhai Trinomab Pharmaceutical Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05811793", "BriefTitle": "Efficacy and Safety of SCAI of Bevacizumab Combined With IC of Tislelizumab in the Treatment of Recurrent Glioblastoma.", "OfficialTitle": "Efficacy and Safety of Superselective Cerebral Arterial Infusion of Bevacizumab Combined With Intrathecal Injection of Tislelizumab in the Treatment of Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2023-04-15", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Tislelizumab and Bevacizumab", "Type": "DRUG", "Description": "Tislelizumab is a drug material authorized for marketing in China. Tislelizumab will be administered off-label in this study. Subjects with recurrent GBM will receive intrathecal tislelizumab every 3 weeks for six times. Intrathecal administration of Bevacizumab will be performed via Ommaya reservoir or intraventricular catheter.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Second Affiliated Hospital of Nanchang University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Zhejiang University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03139916", "BriefTitle": "Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase II Clinical Trial of Bavituximab With Radiation and Temozolomide for Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-09-13", "PrimaryCompletionDate": "2022-08-31", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide causes cell death and shrinks and kills the cancer cells", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Bavituximab", "Type": "DRUG", "Description": "Bavituximab may activate (cause) the immune system to attack the cancer cells", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Radiation causes cell death and shrinks and kills the cancer cells.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Peregrine Pharmaceuticals", "National Comprehensive Cancer Network" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02667587", "BriefTitle": "An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)", "OfficialTitle": "A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2016-05-09", "PrimaryCompletionDate": "2020-12-22", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Opdivo", "Nivo", "N", "BMS-936558" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar", "TMZ", "Temodal", "Temcad" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Nivolumab Placebo", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bristol-Myers Squibb", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Ono Pharmaceutical Co. Ltd" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03119064", "BriefTitle": "BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma", "OfficialTitle": "BrUOG 329: Onivyde (Nanoliposomal Irinotecan) and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: A Phase IB/IIA Brown University Oncology Research Group Study", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-11-30", "PrimaryCompletionDate": "2020-04-10", "Interventions": [ { "Name": "Nanoliposomal Irinotecan", "Type": "DRUG", "Description": "Three patients will be accrued to level 1. If no dose limiting toxicities are observed following completion of 4 weeks (2 cycles) of treatment then accrual to dose level 2 will proceed (patients must be evaluated prior to their cycle 3 treatment and this will be used to confirm DLTs). If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Accrual will continue in this way until the MTD of nanoliposomal irinotecan with temozolomide 50mg/m2/day is determined. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If two or more instances of DLT in a cohort of 6 patients occurs in dose level 1 then dose level -1 of nanoliposomal irinotecan will be investigated. After determination of the MTD, the final cohort will be expanded so that a total of 25 patients are treated on study. The final cohort will be treated at the MTD.", "OtherNames": [ "Onivyde" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Three patients will be accrued to level 1. If no dose limiting toxicities are observed following completion of 4 weeks (2 cycles) of treatment then accrual to dose level 2 will proceed (patients must be evaluated prior to their cycle 3 treatment and this will be used to confirm DLTs). If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Accrual will continue in this way until the MTD of nanoliposomal irinotecan with temozolomide 50mg/m2/day is determined. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If two or more instances of DLT in a cohort of 6 patients occurs in dose level 1 then dose level -1 of nanoliposomal irinotecan will be investigated. After determination of the MTD, the final cohort will be expanded so that a total of 25 patients are treated on study. The final cohort will be treated at the MTD.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Brown University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merrimack Pharmaceuticals", "Rhode Island Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05694416", "BriefTitle": "Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Glioblastoma", "OfficialTitle": "Etoposide Plus Cisplatin Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2023-02-01", "PrimaryCompletionDate": "2024-03-01", "Interventions": [ { "Name": "Etoposide Plus Cisplatin", "Type": "DRUG", "Description": "Etoposide Plus Cisplatin ivdrip d1-5", "OtherNames": [ "EP" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Zhongnan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04915404", "BriefTitle": "Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV)", "OfficialTitle": "A Multicenter, Open-Label Study of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-12-07", "PrimaryCompletionDate": "2023-12-30", "Interventions": [ { "Name": "Berubicin Hydrochloride", "Type": "DRUG", "Description": "Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base (equivalent to 7.5 mg/m2 Berubicin HCl) as a 2-hour intravenous (IV) infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "WPD Pharmaceuticals Sp. z o.o.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Worldwide Clinical Trials", "National Center for Research and Development, Poland" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04002804", "BriefTitle": "Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme", "OfficialTitle": "Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2011-10", "Interventions": [ { "Name": "Dendritic Cells Vaccine", "Type": "BIOLOGICAL", "Description": "Right after the surgical resection of the recurrent tumor, leukapheresis will be performed.\n\nAt least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.\n\nStarting at week 3, immunotherapy will include 4 bi-weeekly vaccinations first (injections I, II, III, IV), two further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) two months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only.\n\nVaccine doses will be injected in the forearm of the patient.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00179907", "BriefTitle": "A Phase I/II Study of the Photon Radiosurgery System", "OfficialTitle": "A Phase I/II Study of Reirradiation for Recurrent Pediatric Brain and Spinal Cord Tumors and Primary Glioblastoma Multiforme Using the Photon Radiosurgery System", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-05", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "Photon Radiosurgery System (Intrabeam)", "Type": "PROCEDURE", "Description": "In this study we had intended to perform a similar dose escalation study with doses ranging from 10-19 Gy, 10-16 Gy and 10 - 14 Gy for tumors \\< 20 mm, 21-25 mm and 26-40 mm respectively", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ann & Robert H Lurie Children's Hospital of Chicago", "LeadSponsorClass": "OTHER", "Collaborators": [ "Photoelectron Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00329719", "BriefTitle": "Sorafenib Tosylate and Temsirolimus in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase I/II Trial of Sorafenib and CCI-779 in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-03-24", "PrimaryCompletionDate": "2013-02-01", "Interventions": [ { "Name": "Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Sorafenib Tosylate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BAY 43-9006 Tosylate", "BAY 54-9085", "Nexavar", "sorafenib" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Temsirolimus", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CCI-779", "CCI-779 Rapamycin Analog", "Cell Cycle Inhibitor 779", "Rapamycin Analog", "Rapamycin Analog CCI-779", "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT05956821", "BriefTitle": "Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age", "OfficialTitle": "Phase I/II Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-06-19", "PrimaryCompletionDate": "2029-10-01", "Interventions": [ { "Name": "SIACI of cetuximab and bevacizumab", "Type": "DRUG", "Description": "Subjects will receive monthly dosing of bevacizumab (15 mg/kg) and cetuximab (200mg/m2)", "OtherNames": [ "erbitux", "avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Miami", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06333899", "BriefTitle": "Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion", "OfficialTitle": "A Pilot Study of Lorlatinib for Treatment of Children With Newly Diagnosed High-Grade Glioma With ROS-1 (ROS Proto-Oncogene 1, Receptor Tyrosine Kinase) or ALK (Anaplastic Lymphoma Kinase) Fusion", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-08-03", "PrimaryCompletionDate": "2029-07-01", "Interventions": [ { "Name": "Lorlatinib", "Type": "DRUG", "Description": "Continue maintenance monotherapy for total 12 cycles", "OtherNames": [ "LOBRENA" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lorlatinib with chemotherapy1", "Type": "DRUG", "Description": "Continue lorlatinib with BABY-POG chemotherapy backbone for 72 weeks", "OtherNames": [ "LOBRENA" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lorlatinib with chemotherapy 2", "Type": "DRUG", "Description": "Continue lorlatinib with HIT-SKK chemotherapy backbone for 42 weeks", "OtherNames": [ "LOBRENA" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lorlatinib post Radiation", "Type": "DRUG", "Description": "Continue lorlatinib monotherapy 28 days post completion of radiation therapy for 12 cycles", "OtherNames": [ "LOBRENA" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Nationwide Children's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03649464", "BriefTitle": "Investigation of Oral OKN-007 in Recurrent High-grade Glioma Participants", "OfficialTitle": "A Phase Ib/2 Open-label Study Investigating the Tolerability, Safety, Pharmacokinetic Properties and Efficacy of Oral OKN-007 in Participants With Recurrent High-grade Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-08", "PrimaryCompletionDate": "2025-04", "Interventions": [ { "Name": "OKN-007", "Type": "DRUG", "Description": "Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID).\n\nExpansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study.", "OtherNames": [ "Anti-Cancer Agent" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oblato, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05737212", "BriefTitle": "Studying the Safety, Efficacy, and Pharmacokinetic Characteristics of BNCT in Patients With Recurrent High-grade Gliomas", "OfficialTitle": "A Multi-centered, Radiation Dose Escalation, Open, Exploratory, Phase 1/2a Clinical Trial on the Safety, Efficacy and Pharmacokinetic Characteristics of BNCT(Boron Neutron Capture Therapy) in Patients With Recurrent High-grade Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-12-05", "PrimaryCompletionDate": "2024-06-11", "Interventions": [ { "Name": "500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 9Gy-Eq", "Type": "RADIATION", "Description": "Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 11Gy-Eq", "Type": "RADIATION", "Description": "Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "500mg/kg/3hr followed by neutron irradiation to reach maximum brain dose of 13Gy-Eq", "Type": "RADIATION", "Description": "Patients will be infused DMX-101 intravenously at a dose of 500mg/kg/hr over 3 hours. Thereafter, patient will receive neutron irradiation simultaneously for a certain period of time based on his Boronophenylalanine (BPA) concentration in the blood.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dawonmedax Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01169415", "BriefTitle": "Effects of Steroid Tapering on Functional Capacity and Neurocognition", "OfficialTitle": "Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2010-06", "PrimaryCompletionDate": "2014-05", "Interventions": [ { "Name": "Dexamethasone acetate", "Type": "DRUG", "Description": "Participants will receive a protracted (30 days) course of dexamethasone after surgery.", "OtherNames": [ "Decadron" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Dexamethasone", "Type": "DRUG", "Description": "Participants will receive a protracted (14 days) course of dexamethasone after surgery.", "OtherNames": [ "Decadron" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00788125", "BriefTitle": "Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors", "OfficialTitle": "Dasatinib With Ifosfamide, Carboplatin, Etoposide: A Pediatric Phase I/II Trial", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-09-03", "PrimaryCompletionDate": "2010-04-30", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "dasatinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "etoposide phosphate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "ifosfamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "microarray analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "western blotting", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04752280", "BriefTitle": "Glioblastoma Radiotherapy Using IMRT or Proton Beams", "OfficialTitle": "Glioblastoma Radiotherapy Using IMRT or Proton Beams", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2021-04-19", "PrimaryCompletionDate": "2025-08-19", "Interventions": [ { "Name": "Proton irradiation", "Type": "RADIATION", "Description": "proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Photon irradiation", "Type": "RADIATION", "Description": "proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital Heidelberg", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07003542", "BriefTitle": "A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas", "OfficialTitle": "Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-08-08", "PrimaryCompletionDate": "2027-06", "Interventions": [ { "Name": "Sitagliptin", "Type": "DRUG", "Description": "Sitagliptin will be self-administered orally by participants.\n\nDose level - sitagliptin\n\n* 1 100 mg daily\n* -1 50 mg daily\n* -2 25 mg daily", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03283631", "BriefTitle": "Intracerebral EGFR-vIII CAR-T Cells for Recurrent GBM", "OfficialTitle": "INTERCEPT: INTracerebral EGFR-vIII Chimeric Antigen Receptor Gene-Modified T CElls for PaTients With Recurrent GBM", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-05-30", "PrimaryCompletionDate": "2019-09-19", "Interventions": [ { "Name": "EGFRvIII-CARs", "Type": "BIOLOGICAL", "Description": "Gamma-retroviral MSGV1 139 scFv EGFRvIII CAR gene-modified T cells", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Gary Archer Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Duke Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT01174537", "BriefTitle": "New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma", "OfficialTitle": "Clinical Application of Intravenous New Castle Disease Virus - HUJ Oncolytic Virus in the Treatment of Advanced Glioblastoma Multiforme, Soft and Bone Sarcomas and Neuroblastoma Patients, Resistant to Conventional Anti- Cancer Modalities", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-07", "PrimaryCompletionDate": "2011-07", "Interventions": [ { "Name": "New Castle Disease Virus", "Type": "BIOLOGICAL", "Description": "Patients will receive IV 1\\*10\\^10 EID50 (50 percent Embryo Infectious Dose. One EID50 unit is the amount of virus that will infect 50 percent of inoculated eggs) on a daily basis for a minimum of 5 days a week until disease progression for a minimum duration of 1 year.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hadassah Medical Organization", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00433472", "BriefTitle": "MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806", "OfficialTitle": "Effect of RSR13 on T2 and T2* Cranial MRI Images: An Imaging Companion Study to NABTT 9806", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": null, "PrimaryCompletionDate": null, "Interventions": [ { "Name": "magnetic resonance imaging (MRI)", "Type": "DEVICE", "Description": "MRI scan to be complete to look at RSR13 on measurement of T2 and T2\\* on MRI", "OtherNames": [ "MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00479765", "BriefTitle": "A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma", "OfficialTitle": "A Phase 1 / 2 Dose Escalation Study of Locally-Administered OncoGel™ in Subjects With Recurrent Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-03", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "OncoGel (ReGel/Paclitaxel)", "Type": "DRUG", "Description": "OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boston Scientific Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07121842", "BriefTitle": "Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI", "OfficialTitle": "GLIMPCE: Glioblastoma Imaging for the Detection of Tumor Progression Using APTw-CEST MRI", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-01-15", "PrimaryCompletionDate": "2027-01", "Interventions": [ { "Name": "Extended MRI", "Type": "DIAGNOSTIC_TEST", "Description": "The MRI protocol for every clinical follow-up MRI scan is extended with 15 minutes to add the APTw-CEST scan.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Erasmus Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "UMC Utrecht", "LeidenUMC", "Amsterdam UMC, location VUmc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02586857", "BriefTitle": "A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase 1b/2, Multicenter, Open-label Study of ACP-196 in Subjects With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-01-25", "PrimaryCompletionDate": "2020-06-26", "Interventions": [ { "Name": "ACP-196", "Type": "DRUG", "Description": "Cohort 1: ACP-196 200 mg (PO) twice per day (BID) Cohort 2: ACP-196 400 mg (PO) once per day (QD).", "OtherNames": [ "Acalabrutinib." ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Acerta Pharma BV", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05557240", "BriefTitle": "Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients", "OfficialTitle": "Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2022-09-13", "PrimaryCompletionDate": "2024-02-12", "Interventions": [ { "Name": "NeoPep Vaccine1 plus Poly-ICLC", "Type": "DRUG", "Description": "NPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used.\n\nPoly-ICLC:\n\nPoly-ICLC（500ug）will be used as immunomodulator with all vaccinations.", "OtherNames": [ "NPVAC1+Poly-ICLC" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "NeoPep Vaccine2 plus Poly-ICLC", "Type": "DRUG", "Description": "NPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used.\n\nPoly-ICLC:\n\nPoly-ICLC（500ug）will be used as immunomodulator with all vaccinations.", "OtherNames": [ "NPVAC2+Poly-ICLC" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Shanghai 10th People's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Hangzhou NeoVax Biotechnology Co. Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01149850", "BriefTitle": "Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase II Study of Bevacizumab and Temozolomide in Elderly Patients With Newly-Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-04-28", "PrimaryCompletionDate": "2023-12-08", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "anti-VEGF rhuMAb", "Avastin", "recombinant humanized anti-VEGF monoclonal antibody", "rhuMAb VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CCRG-81045", "M & B 39831", "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "immunohistochemistry" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "microarray analysis", "Type": "GENETIC", "Description": "Correlative studies", "OtherNames": [ "gene expression profiling" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "DNA methylation analysis", "Type": "GENETIC", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Epigenetic modifier" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Epigenetic modifier" ] } }, { "NCTId": "NCT00075491", "BriefTitle": "Neoadjuvant and Adjuvant Fenretinide Compared With Adjuvant Fenretinide Alone in Treating Patients Who Are Undergoing Surgical Resection For Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Evaluation With Correlative Studies Of Fenretinide (NSC 374551-4HPR) As A Single Agent In The Treatment Of Adult Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2003-12", "PrimaryCompletionDate": "2005-03", "Interventions": [ { "Name": "fenretinide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "fenretinimide", "McN-R-1967" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02359097", "BriefTitle": "Steady State Blood Volume Maps Using Ferumoxytol Non-stoichiometric Magnetite MRI in Imaging Patients With Glioblastoma", "OfficialTitle": "High Resolution Steady State Blood Volume Maps in Glioblastoma Using MRI - A Multicenter Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2015-01-06", "PrimaryCompletionDate": "2021-03-12", "Interventions": [ { "Name": "Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI including DSC or DCE-CBV mapping", "OtherNames": [ "DSC-MRI", "Dynamic Susceptibility Contrast-Enhanced MRI", "DYNAMIC SUSCEPTIBILITY-CONTRAST MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Ferumoxytol", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Feraheme", "Ferumoxytol Non-Stoichiometric Magnetite" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Gadoteridol", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Gadoteridolum", "GD-HP-DO3A", "HSDB 7549", "ProHance", "SQ 32692" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI including SS-CBV", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "OHSU Knight Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Oregon Health and Science University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04933942", "BriefTitle": "Phase II Trial of Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-meth Glioblastoma", "OfficialTitle": "Romiplostim for Thrombocytopenia Induced by Lomustine at First Progression of MGMT Promoter-methylated Glioblastoma: a Randomized Phase II Open Label Multicenter Study", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2022-09-13", "PrimaryCompletionDate": "2022-12-19", "Interventions": [ { "Name": "Lomustine", "Type": "DRUG", "Description": "Oral administration of Lomustine", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Romiplostim", "Type": "DRUG", "Description": "Subcutaneous administration of Romiplostim", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Amgen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06595186", "BriefTitle": "JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Multicenter, Single Arm, Open-label, Dose-escalation Phase 2 Study of JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM) After Surgery and Concomitant Radio-chemotherapy", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-10-31", "PrimaryCompletionDate": "2026-08-16", "Interventions": [ { "Name": "JK-1201I", "Type": "DRUG", "Description": "JK-1201I will be administered.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Temozolomide will be administered.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "JenKem Technology Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00014170", "BriefTitle": "Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study Of ZD1839 (NSC 715055) In Newly Diagnosed Patients With Glioblastoma (Grade 4 Astrocytoma)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-03", "PrimaryCompletionDate": "2003-07", "Interventions": [ { "Name": "gefitinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "Iressa", "ZD 1839" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "questionnaire administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "quality-of-life assessment", "Type": "PROCEDURE", "Description": "Ancillary studies", "OtherNames": [ "quality of life assessment" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04555577", "BriefTitle": "Peposertib and Radiation Therapy, Followed by Temozolomide for the Treatment of Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma or Gliosarcoma", "OfficialTitle": "Phase I Trial of DNA-PK Inhibitor (M3814) in Combination With Radiation and Adjuvant Temozolomide in Newly Diagnosed MGMT Unmethylated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-09-20", "PrimaryCompletionDate": "2027-12-31", "Interventions": [ { "Name": "Peposertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Surgical Resection" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06521567", "BriefTitle": "A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer", "OfficialTitle": "Phase 1/2 Dose Determination and Dose Expansion Study of Cobolimab in Combination With Dostarlimab in Pediatric and Young Adult Participants With Newly Diagnosed and Relapsed/Refractory Tumors (POPSTAR)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-03-06", "PrimaryCompletionDate": "2026-10-13", "Interventions": [ { "Name": "Cobolimab", "Type": "DRUG", "Description": "Cobolimab will be administered", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dostarlimab", "Type": "DRUG", "Description": "Dostarlimab will be administered", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "GlaxoSmithKline", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02678975", "BriefTitle": "Disulfiram in Recurrent Glioblastoma", "OfficialTitle": "DIRECT (DIsulfiram REsponse as add-on to ChemoTherapy in Recurrent) Glioblastoma: A Randomized Controlled Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2017-01", "PrimaryCompletionDate": "2021-01-15", "Interventions": [ { "Name": "Disulfiram", "Type": "DRUG", "Description": "Disulfiram 400 mg daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Copper", "Type": "DIETARY_SUPPLEMENT", "Description": "nutritional supplement with copper, 2 mg daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Alkylating Agents", "Type": "DRUG", "Description": "Alkylating antineoplastic agent", "OtherNames": [ "lomustine (CCNU), PCV or temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sahlgrenska University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "St. Olavs Hospital", "Lund University Hospital", "Karolinska University Hospital", "University Hospital, Linkoeping", "Region Örebro County", "Ryhov County Hospital", "Uppsala University Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02850744", "BriefTitle": "Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of PQR309 in Glioblastoma Patients", "OfficialTitle": "Open-label, Non-randomized, Two-stage Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamic Effects of PQR309 in Patients With Progressive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-07", "PrimaryCompletionDate": "2017-11", "Interventions": [ { "Name": "PQR309", "Type": "DRUG", "Description": "80mg capsules p.o. once daily and possibly Standard Treatment with temozolomide", "OtherNames": [ "temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "PIQUR Therapeutics AG", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University Hospital, Basel, Switzerland", "Insel Gruppe AG, University Hospital Bern", "University Hospital, Zürich" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03020602", "BriefTitle": "BPM31510 in Treating Patients With Recurrent High-Grade Glioma Previously Treated With Bevacizumab", "OfficialTitle": "A Phase I Study of BPM31510 Plus Vitamin K in Subjects With High-Grade Glioma That Has Recurred on a Bevacizumab Containing Regimen", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-01-04", "PrimaryCompletionDate": "2019-04-04", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Ubidecarenone Injectable Nanosuspension", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BP31510", "Coenzyme Q10 Injectable Nanosuspension", "Ubiquinone Injectable Nanosuspension" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Seema Nagpal", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01269411", "BriefTitle": "RO4929097 in Treating Patients With Recurrent Invasive Gliomas", "OfficialTitle": "Phase I Pharmacodynamic and \"High Content\" Study of the Gamma-Secretase Inhibitor RO4929097 in Patients With Recurrent Malignant Gliomas (MGs) Targeting p75NTR to Inhibit Brain Tumor Initiating Cells (BTICs) and Recurrent Invasive Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-07", "PrimaryCompletionDate": "2012-02", "Interventions": [ { "Name": "gamma-secretase/Notch signalling pathway inhibitor RO4929097", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "R4733", "RO4929097" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02208362", "BriefTitle": "Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma", "OfficialTitle": "Phase I Study of Cellular ImmunoTx Using Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Pts With Rec/Ref MaligGlioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2015-05-18", "PrimaryCompletionDate": "2021-02-08", "Interventions": [ { "Name": "Arm 1: IL13Ra2-specific CAR Tcm cells", "Type": "BIOLOGICAL", "Description": "Given via intratumoral catheter", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T Cells", "IL13Ra2-CAR/CD19t+ Tcm" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Arm 2: IL13Ra2-specific CAR Tcm cells", "Type": "BIOLOGICAL", "Description": "Given via intratumoral/intracavitary catheter", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T Cells", "IL13Ra2-CAR/CD19t+ Tcm" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Arm 3: IL13Ra2-specific CAR Tcm cells", "Type": "BIOLOGICAL", "Description": "Given via intraventricular catheter", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T Cells", "IL13Ra2-CAR/CD19t+ Tcm" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Arm 4: IL13Ra2-specific CAR Tcm cells", "Type": "BIOLOGICAL", "Description": "Given via intratumoral or intracavitary, and via intraventricular catheter", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ Tcm-enriched T Cells", "IL13Ra2-CAR/CD19t+ Tcm" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Arm 5: IL13Ra2-specific CAR Tn/mem cells", "Type": "BIOLOGICAL", "Description": "Given via intratumoral or intracavitary, and via intraventricular catheter", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ Tn/mem-enriched T Cells", "IL13Ra2-CAR/CD19t+ Tn/mem" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR Imaging", "MRI", "MRI Scan", "MRI Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Spectroscopic Imaging", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "1H- Nuclear Magnetic Resonance Spectroscopic Imaging", "1H-nuclear magnetic resonance spectroscopic imaging", "Magnetic Resonance Spectroscopy", "MRS", "MRS Imaging", "MRSI", "Proton Magnetic Resonance Spectroscopic Imaging" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Food and Drug Administration (FDA)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05333588", "BriefTitle": "The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.", "OfficialTitle": "The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-02-15", "PrimaryCompletionDate": "2024-02-15", "Interventions": [ { "Name": "Tumor Infiltrating Lymphocytes (TIL)", "Type": "BIOLOGICAL", "Description": "The autologous TILs will be intravenous infused into patients.", "OtherNames": [ "TILs" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hebei Senlang Biotechnology Inc., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04047303", "BriefTitle": "CNS Penetration, PK and PD of Preoperative CC-90010 in Progressive/Recurrent Diffuse Astrocytoma, Anaplastic Astrocytoma and Glioblastoma", "OfficialTitle": "A Phase 1, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects With Progressive or Recurrent Who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2020-01-02", "PrimaryCompletionDate": "2024-06-03", "Interventions": [ { "Name": "CC-90010", "Type": "DRUG", "Description": "CC-90010", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00276770", "BriefTitle": "Positron Emission Tomography Using Fluorothymidine F 18 in Finding Recurrent Disease in Patients With Gliomas", "OfficialTitle": "NCI-Sponsored Trial for the Evaluation of Safety and Preliminary Efficacy Using [F18] Fluorothymidine (FLT) As a Marker of Proliferation in Patients With Primary Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2006-02", "PrimaryCompletionDate": "2007-05", "Interventions": [ { "Name": "fluorine F 18 fluorothymidine", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "positron emission tomography", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Washington", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03834740", "BriefTitle": "A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection", "OfficialTitle": "A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Rb-Intact Recurrent High-Grade Glioma Patients Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2019-01-19", "PrimaryCompletionDate": "2022-02-18", "Interventions": [ { "Name": "Ribociclib", "Type": "DRUG", "Description": "Ribociclib administered orally in 5 daily doses prior to resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "Everolimus administered orally in 5 daily doses prior to resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ivy Brain Tumor Center", "Barrow Neurological Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT01929720", "BriefTitle": "Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors", "OfficialTitle": "Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2011-08", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Cognitive-behavioral therapy for worry, uncertainty & insomnia", "Type": "BEHAVIORAL", "Description": "This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.", "OtherNames": [ "Cognitive-behavioral Therapy", "Acceptance and Commitment Therapy", "Psychological Intervention", "Behavior Therapy", "Behavioral Modification", "Behavioral Therapy", "Behavioral Treatment" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ohio State University Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "American Cancer Society, Inc.", "Lance Armstrong Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00821080", "BriefTitle": "Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase I Study of Vandetanib and Sirolimus in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-10", "PrimaryCompletionDate": "2015-02", "Interventions": [ { "Name": "Sirolimus", "Type": "DRUG", "Description": "Taken orally at different dose levels depending upon enrollment time period", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Vandetanib", "Type": "DRUG", "Description": "Taken orally at different dose levels depending upon enrollment time period", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Brigham and Women's Hospital", "Dana-Farber Cancer Institute", "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT00116376", "BriefTitle": "Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2004-01", "PrimaryCompletionDate": "2005-11", "Interventions": [ { "Name": "AEE788", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01095094", "BriefTitle": "Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma", "OfficialTitle": "Phase II Trial of Ritonavir/Lopinavir in Patients With Progressive of Recurrent High-Grade Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2009-01", "PrimaryCompletionDate": "2010-06", "Interventions": [ { "Name": "ritonavir", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "Norvir", "RIT" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "lopinavir", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "ABT-378/r" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01765088", "BriefTitle": "A Phase III Trial on Adjuvant Temozolomide With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas", "OfficialTitle": "A Phase III Trial on Adjuvant Standard Temozolomide Chemotherapy With or Without Interferon-alpha in Newly Diagnosed High-grade Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2012-09", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days", "OtherNames": [ "Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "α-IFN", "Type": "DRUG", "Description": "3mIU (3million) D1，3，5", "OtherNames": [ "INTRONA" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sun Yat-sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06835803", "BriefTitle": "Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma: A Phase 2 Hybrid Randomized Trial", "OfficialTitle": "Enhanced Local Intensified Radiation Therapy in Elderly Glioblastoma (ELITE-GBM): A Phase 2 Hybrid Randomized Trial Leveraging External Data", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-04-14", "PrimaryCompletionDate": "2028-03-31", "Interventions": [ { "Name": "Dose-escalated radiation therapy", "Type": "RADIATION", "Description": "Dose-escalated radiation therapy involves higher doses of radiation therapy each day of treatment over the three week course of radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standard hypofractionated radiation", "Type": "RADIATION", "Description": "Standard hypofractionated radiation therapy over 3 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Brigham and Women's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06936046", "BriefTitle": "Enhanced Adjuvant Therapy for Newly Diagnosed GBM With Partial Surgical Resection or Short-term Progression", "OfficialTitle": "Enhanced Adjuvant Therapy for Newly Diagnosed Glioblastoma With Partial Surgical Resection or Short-term Progression: a Bayesian Adaptive Randomized Phase II Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-01-01", "PrimaryCompletionDate": "2027-01-01", "Interventions": [ { "Name": "Dual antibody A", "Type": "DRUG", "Description": "Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/VEGF dual antibody will be used as adjuvant therapy. PD-1/VEGF dual antibody 20mg/kg intravenous infusion once, with a cycle of 21 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Dual antibody B", "Type": "DRUG", "Description": "Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. After completing synchronous radiotherapy and chemotherapy for 28 days, TMZ combined with PD-1/CTLA-4 dual antibody will be used as adjuvant therapy. PD-1/CTLA-4 dual antibody 6mg/kg intravenous infusion once, with a cycle of 14 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Modified Stupp", "Type": "RADIATION", "Description": "Starting 2-6 weeks after surgery, synchronous TMZ radiotherapy and chemotherapy will be performed. For partially resected lesions or short-term recurrence and progression lesions after surgery, high-dose PGTV 66Gy/30Gy will be given locally. PTV1 in high-risk areas around the tumor bed will be 60Gy/30F, and in low-risk areas will be 54Gy/30F. After completing synchronous radiotherapy and chemotherapy for 28 days, 6 cycles of adjuvant TMZ chemotherapy will be started.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Stupp protocol", "Type": "DRUG", "Description": "Synchronized TMZ radiotherapy and chemotherapy will begin 2-6 weeks after surgery, and 6 cycles of adjuvant TMZ chemotherapy will begin 28 days after completing the synchronized radiotherapy and chemotherapy. Radiotherapy regimen: PTV1 60Gy/30F in high-risk areas around the tumor bed, 54Gy/30F in low-risk areas. TMZ synchronous chemotherapy regimen: 75mg/m2 po qd. TMZ adjuvant chemotherapy regimen: The first cycle is 150mg/m2 po qd on d1-5,28 days; Cycle 2-6: Cycle 1: 200mg/m2 po qd for d1-5,28 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1", "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01480050", "BriefTitle": "Mibefradil Dihydrochloride and Temozolomide in Treating Patients With Recurrent Glioma", "OfficialTitle": "A Phase I Open Label Safety Study to Evaluate the Pharmacokinetic Profile and Tolerance of Mibefradil Dose Finding in Subjects With Recurrent High-Grade Glioma Undergoing Standard, Repeated Temozolomide Treatment", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-05-31", "PrimaryCompletionDate": "2015-08", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "standard of care drug", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "3'-deoxy-3'-[18F]fluorothymidine", "Type": "OTHER", "Description": "tracer used for FLT PET CT", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Mibefradil", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Cavion, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00187486", "BriefTitle": "Safety and Efficacy Study of Tarceva, Temodar, and Radiation Therapy in Patients With Newly Diagnosed Brain Tumors", "OfficialTitle": "Phase II Study of Tarceva Plus Temodar During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme and Gliosarcoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-08", "PrimaryCompletionDate": "2011-03", "Interventions": [ { "Name": "Tarceva", "Type": "DRUG", "Description": "Tarceva (erlotinib hydrochloride; previously referred to as OSI-774), a quinazoline, is an orally active, potent, selective inhibitor of EGFR tyrosine kinase. 100 - 300 milligrams (mg) every day (QD) orally (PO) every (q) 28 days depending on EIAED Status", "OtherNames": [ "erlotinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temodar", "Type": "DRUG", "Description": "Temodar 200 mg/m\\^2/day x 5 days every 28 days", "OtherNames": [ "temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "PROCEDURE", "Description": "Radiotherapy will be administered in 180 centigray(cGy)/day - 200cGy/day fractions delivered 5 days per week to a total dose of 5940cGy - 6100cGy. A total of 4500cGy will be delivered to the clinical tumor volume consisting of T2-bright edema + a 2centimeter margin, or, if no edema, the contrast enhancing lesion +2.5 centimeter margin. An additional boost of 1440cGy will be delivered to the gross tumor volume consisting of the contrast enhancing lesion + a 1 centimeter margin.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT04817254", "BriefTitle": "Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma", "OfficialTitle": "Phase II Trial Evaluating the Association of Peripheral Blood Immunologic Response to Therapeutic Response to Adjuvant Treatment With Immune Checkpoint Inhibition (ICI) in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-12-08", "PrimaryCompletionDate": "2026-11-30", "Interventions": [ { "Name": "TMZ", "Type": "DRUG", "Description": "150 mg/m2 on days 1-5 of cycles 1-6", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "ipilimumab 3mg/kg", "Type": "DRUG", "Description": "3 mg/kg q 4 weeks for cycles 1-4", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "1 mg/kg IV q2weeks for cycles 1-4, then 480 mg q 4 weeks for cycles 5-16", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "ipilimumab 1mg/kg", "Type": "DRUG", "Description": "1 mg/kg q 4 weeks for cycles 1-4", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT01699269", "BriefTitle": "Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging", "OfficialTitle": "Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging: Peritumoral Glial Cell Infiltration Quantitative Method", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2012-04", "PrimaryCompletionDate": "2013-08", "Interventions": [ { "Name": "peritumoral glial cell infiltration", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Clermont-Ferrand", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SCREENING", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04801147", "BriefTitle": "Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (DENDR1)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-06-26", "PrimaryCompletionDate": "2023-12", "Interventions": [ { "Name": "Dendritic Cells Vaccine", "Type": "BIOLOGICAL", "Description": "Right after the surgical resection of the tumor, leukapheresis will be performed.\n\nAt least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.\n\nImmunotherapy will follow radiochemotherapy and will comprise 4 vaccinations every second week (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 13), mTMZ will start.\n\nVaccine doses will be injected in the forearm of the patient.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02945826", "BriefTitle": "uPAR-PET/MRI in Glioblastoma Multiforme", "OfficialTitle": "uPAR-PET/MRI in Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2017-01", "PrimaryCompletionDate": "2020-12", "Interventions": [ { "Name": "One injection of 68Ga-NOTA-AE105", "Type": "DRUG", "Description": "One injection of 68Ga-NOTA-AE105", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET/MRI", "Type": "DEVICE", "Description": "Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rigshospitalet, Denmark", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01622764", "BriefTitle": "89Zr-RO5323441 PET Imaging in Glioblastoma", "OfficialTitle": "89Zr-RO5323441 PET Imaging in Patients With Recurrent Glioblastoma Treated With Bevacizumab", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2014-09", "PrimaryCompletionDate": "2015-09", "Interventions": [ { "Name": "Molecular imaging with 89Zr-RO5323441", "Type": "RADIATION", "Description": "Bevacizumab at a dose of 10 mg/kg body weight i.v. in 90 min on day 1 will be given every 2 weeks in cycles of 6 weeks, until documented disease progression, unacceptable toxicity, patient refusal or patient's best interest. 89Zr-RO5323441 will be administered i.v. at a tracer dose of 5 mg (37 MBq) on day -3 and on day 11 of cycle 1 of bevacizumab treatment. Four PET scans will be performed (2 brain only PET scans and 2 whole body PET scans). Brain only PET scans will be performed 2 hours after each 89Zr-RO5323441 administration on day -3 and day 11. Whole body PET scans will be performed 4 days after each 89Zr-RO5323441 administration (before dosing with bevacizumab on day 1 and day 15).", "OtherNames": [ "TB403" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University Medical Center Groningen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03025893", "BriefTitle": "A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II/III Study of High-dose, Intermittent Sunitinib in Patients With Recurrent Glioblastoma Multiforme: the STELLAR Study", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2018-08-31", "PrimaryCompletionDate": "2022-01-01", "Interventions": [ { "Name": "Sunitinib", "Type": "DRUG", "Description": "Sunitinib, 300 mg administered orally in a weekly schedule.", "OtherNames": [ "Sutent" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.", "OtherNames": [ "CCNU" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Amsterdam UMC, location VUmc", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01186406", "BriefTitle": "Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM)", "OfficialTitle": "Phase II Trial for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Concurrent Radiation Therapy, Temodar and Avastin, Then Followed by Avastin and Temodar Post-Radiation", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-04", "PrimaryCompletionDate": "2014-06-16", "Interventions": [ { "Name": "Gliadel", "Type": "DRUG", "Description": "Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection.", "OtherNames": [ "Gliadel (carmustine wafers)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Avastin", "Type": "DRUG", "Description": "Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.\n\nBeginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days.", "OtherNames": [ "Avastin (bevacizumab)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temodar", "Type": "DRUG", "Description": "At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation. In addition, beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with 5 day Temodar (200 mg/ m2).", "OtherNames": [ "Temodar (temozolomide)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Eisai Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00369590", "BriefTitle": "VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide", "OfficialTitle": "Phase II Single Arm Trial of VEGF Trap in Patients With Recurrent Temozolomide-Resistant Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-08", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "ziv-aflibercept", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "aflibercept", "vascular endothelial growth factor trap", "VEGF Trap", "Zaltrap" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04747145", "BriefTitle": "Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma", "OfficialTitle": "A Phase II Study Analyzing Pulsed Reduced Dose Radiotherapy in Upfront Glioblastoma (PRORADGLIO Study)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-06-03", "PrimaryCompletionDate": "2025-03-05", "Interventions": [ { "Name": "Radiation", "Type": "DEVICE", "Description": "60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.", "OtherNames": [ "Pulsed Reduced Dose Radiotherapy", "pRDR" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Concurrent Chemotherapy (Temozolomide)", "Type": "DRUG", "Description": "75mg/m\\^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.", "OtherNames": [ "TMZ", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Adjuvant Chemotherapy (Temozolomide)", "Type": "DRUG", "Description": "Starting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m\\^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles.", "OtherNames": [ "TMZ", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Medical College of Wisconsin", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06012695", "BriefTitle": "NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase Ib/II, Open-label Study of NBM-BMX As Monotherapy or in Combination with Radiotherapy and Temozolomide in Subjects with Solid Tumors or Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-08-11", "PrimaryCompletionDate": "2028-05-30", "Interventions": [ { "Name": "NBM-BMX Capsule", "Type": "DRUG", "Description": "Each capsule contains 100 mg of the active ingredient.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "TMZ will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.", "OtherNames": [ "Temodal® Capsules" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard radiotherapy", "Type": "RADIATION", "Description": "A total dose of 60 Gy will be administered in 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Novelwise Pharmaceutical Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05589961", "BriefTitle": "Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme", "OfficialTitle": "Safety and Efficacy of TRPP Therapy in Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-10", "PrimaryCompletionDate": "2024-07", "Interventions": [ { "Name": "TMZ", "Type": "DRUG", "Description": "After enrollment, temozolomide 50mg/m2 was given orally for QD until progression, and radiotherapy and PF 0.2g/ time for TID were started one week later until progression. Pembrolizumab 200mg once every 3 weeks until progression; The radiotherapy regimen depends on the patient's recurrence and initial treatment.", "OtherNames": [ "PD-1", "RF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "The Second Hospital of Hebei Medical University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00039572", "BriefTitle": "Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain", "OfficialTitle": "A Phase I/II Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-05", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "boronophenylalanine-fructose complex", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Beth Israel Deaconess Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06466031", "BriefTitle": "Application of MET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme", "OfficialTitle": "Application of MET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-09-01", "PrimaryCompletionDate": "2029-07-31", "Interventions": [ { "Name": "MRI & PET fusion", "Type": "OTHER", "Description": "MRI+T1C in fusion with MET-PET will be used for tumor resection and/or radiotherapy planning. Resection will be terminated after removal of PET-assigned tumor margin or in case any neuromonitoring-based indications regarding neurological damage occur.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "MRI+T1C", "Type": "OTHER", "Description": "MRI+T1C will be used for tumor resection and radiotherapy planning. Resection will be terminated after removal of contrast-enhancing part regardless of 5-ALA fluorescence or in case any neuromonitoring-based indications regarding neurological damage occur.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Copernicus Memorial Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Medical Research Agency, Poland" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00392886", "BriefTitle": "Combination Chemotherapy With or Without Etoposide Followed By an Autologous Stem Cell Transplant in Treating Young Patients With Previously Untreated Malignant Brain Tumors", "OfficialTitle": "Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa and Carboplatin, With or Without Etoposide) and Autologous Stem Cell Rescue [HEAD START III]", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2004-03", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": "Given IV and orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "methotrexate", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": "Given on day 0", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous hematopoietic stem cell transplantation", "Type": "PROCEDURE", "Description": "Given on day 0", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": "Given on day 0", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Some patients undergo radiation therapy once daily, 5 days a week for 4-6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Hospital Los Angeles", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05769660", "BriefTitle": "A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)", "OfficialTitle": "An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patient with Recurrent or Progressive Glioblastoma Multiforme (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-11-29", "PrimaryCompletionDate": "2026-11-30", "Interventions": [ { "Name": "BEY1107", "Type": "DRUG", "Description": "Administer twice daily, PO, 4-week continuous dose.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "COMBINATION_PRODUCT", "Description": "Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "BeyondBio Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05190315", "BriefTitle": "Chlorpromazine and Standard of Care in Glioblastoma", "OfficialTitle": "A Phase I Trial of Chlorpromazine Together With Standard of Care in New Diagnosis of Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-01-28", "PrimaryCompletionDate": "2023-04-25", "Interventions": [ { "Name": "Chlorpromazine", "Type": "DRUG", "Description": "Concurrent Phase: Oral chlorpromazine at 25 mg daily for the first 3 patients, then dose escalate to 50 mg if no dose limiting toxicity (DLT). Starting 7 days prior to radiation start.\n\nInterim Phase: Chlorpromazine, 25 mg per day for first 3 subjects and then dose escalate to 50 mg per day if no DLT, will continue post radiation and prior to beginning adjuvant temozolomide.\n\nAdjuvant Phase: Chlorpromazine, 25 mg per day for first 3 subjects and then dose escalate to 50 mg per day if no DLT, will be continued daily (7 days per week) concomitant with Temozolomide.", "OtherNames": [ "Thorazine" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concurrent Phase: Oral temozolomide at 75 mg/m2 per day concomitant with focal radiation and chlorpromazine. Temozolomide should be started on day 1 of radiation therapy, either at bedtime or morning as per patient preference.\n\nAdjuvant Phase: Oral Temozolomide concomitant with Chlorpromazine, starting Temozolomide dose (Cycle 1) is 150 mg/m2 daily with a single dose escalation to 200 mg/m2 daily in subsequent cycles if no treatment-related adverse events \\> grade 2 are noted. Temozolomide to be taken once daily for 5 consecutive days (1-5) of a 28 day cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Concurrent Phase: Radiation therapy administered daily, M-F, to a total dose of 60 Gy in 2 Gy Fractions for a total of 30 fractions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mohammed Milhem", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01273090", "BriefTitle": "Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma", "OfficialTitle": "A Phase 1 Study of Imetelstat, a Telomerase Inhibitor, in Children With Refractory or Recurrent Solid Tumors and Lymphomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2013-09", "Interventions": [ { "Name": "imetelstat sodium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "TERT" ], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "TERT" ], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "TERT" ], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET", "TERT" ], "classes": [] } }, { "NCTId": "NCT05669820", "BriefTitle": "Antisecretory Factor Glioblastoma Phase 2", "OfficialTitle": "Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2024-01-15", "PrimaryCompletionDate": "2026-12-01", "Interventions": [ { "Name": "Salovum", "Type": "DIETARY_SUPPLEMENT", "Description": "Salovum is an eggyolkpowder derived from hens fed with SPC (specially processed cereals) and contains increased amounts of the endogenous protein antisecretory factor.", "OtherNames": [ "Antisecretory factor" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo egg yolk powder", "Type": "DIETARY_SUPPLEMENT", "Description": "Egg yolk powder derived from hen fed with normal feed.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Peter Siesjö", "LeadSponsorClass": "OTHER", "Collaborators": [ "Lund University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00045110", "BriefTitle": "Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma", "OfficialTitle": "A Phase I/II Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-08", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "given orally", "OtherNames": [ "CP-358,774", "erlotinib", "OSI-774" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01540513", "BriefTitle": "PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404", "OfficialTitle": "PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2012-03", "PrimaryCompletionDate": "2014-10", "Interventions": [ { "Name": "NM404", "Type": "DRUG", "Description": "injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging\n\nOther Names:\n\nPET imaging with I-124 NM404", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "NM404", "Type": "DRUG", "Description": "injection of an experimental imaging agent, 5mCi I-124NM404", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of Wisconsin, Madison", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04397679", "BriefTitle": "Partial Brain RT, Temozolomide, Chloroquine, and TTF Therapy for the Treatment of Newly Diagnosed Glioblastoma", "OfficialTitle": "Treatment of Adults with Newly Diagnosed Glioblastoma with Partial Brain Radiation Therapy Plus Temozolomide and Chloroquine Followed by Tumor Treating Fields Plus Temozolomide and Chloroquine -- a Pilot Study", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2021-08-12", "PrimaryCompletionDate": "2024-05-14", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3D CRT", "OtherNames": [ "3-dimensional radiation therapy", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy", "Radiation", "3D Conformal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Intensity-Modulated Radiation Therapy (IMRT)", "Type": "RADIATION", "Description": "Undergo IMRT", "OtherNames": [ "IMRT", "Intensity Modulated RT", "INTENSITY-MODULATED RADIATION THERAPY", "Intensity-Modulated Radiotherapy", "Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 362856", "8-carbamoyl-3-methylimidazo[5,1-d]-1,2,3,5-tetrazin-4(3H)-one, 85622-93-1, CCRG-81045", "imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3", "4-dihydro-3-methyl-4-oxo-, Imidazo[5,1-d]", "1,2,3,5-tetrazine-8-carboxamide", "3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Chloroquine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "54-05-7" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Tumor Treating Fields Therapy (TTF)", "Type": "PROCEDURE", "Description": "Undergo TTF", "OtherNames": [ "Alternating Electric Field Therapy", "TTF", "TTFields" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Barbara Ann Karmanos Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05342883", "BriefTitle": "GammaTile and Stupp in Newly Diagnosed GBM", "OfficialTitle": "Pilot Study of Resection and GammaTile Followed by Concomitant External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant in Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE4" ], "StartDate": "2022-08-17", "PrimaryCompletionDate": "2027-12-01", "Interventions": [ { "Name": "Surgical tumor resection, GammaTile radiation therapy implantation, Stupp protocol (EBRT and Temozolamide)", "Type": "DEVICE", "Description": "At the initiation of the surgical phase maximal safe resection will be undertaken, and after 25 + 4 from surgery participants will start the concomitant phase and receive daily temozolomide (TMZ, 75mg/m2) and 20 fractions external beam radiation (EBRT). The EBRT treatment will be to the operative bed and any residual disease identified at the time of the imaging obtained for EBRT planning. The EBRT planning will utilize the GT implant dosimetry with the intent that the dose received from the GT will be accounted for during the EBRT treatment planning process. Twenty-eight days ±7 after the completion of concomitant TMZ and EBRT, participants will enter the adjuvant phase and will be treated with TMZ (150-200mg/m2) for 5 days at the start of every 28- day cycle, for 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "GT Medical Technologies, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01934361", "BriefTitle": "Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-02-28", "PrimaryCompletionDate": "2016-07-07", "Interventions": [ { "Name": "buparlisib", "Type": "DRUG", "Description": "Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": "Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "lomustine", "Type": "DRUG", "Description": "Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "placebo", "Type": "DRUG", "Description": "Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05611645", "BriefTitle": "Low-dose Bevacizumab With HSRT vs BVZ Alone for GBM at First Recurrence", "OfficialTitle": "A Randomized Phase II Trial of Concurrent Low-dose Bevacizumab and HSRT Versus Bevacizumab Alone for Glioblastoma at First Recurrence: HSCK-005", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2022-10-01", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Hypofractionated Stereotactic Radiotherapy", "Type": "RADIATION", "Description": "Starting with low-dose bevacizumab, 25Gy in 5 fractions of 5 Gy each delivered on consecutive treatment days.", "OtherNames": [ "Hypofractionated Stereotactic Radiosurgery", "Image-Guided Radiation Treatment (IGRT)", "Stereotactic Radiosurgery (SRS)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Staring within 2 weeks of randomization, IV 5mg/kg (experimental group) or 10mg/kg (comparison group) every two weeks until disease progression.", "OtherNames": [ "anti-VEGF monoclonal antibody", "rhuMAb VEGF", "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00459381", "BriefTitle": "Pazopanib in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase II Trial of GW786034 (Pazopanib) in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-05", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "pazopanib hydrochloride", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "GW786034B", "Votrient" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05432375", "BriefTitle": "Study of Tinostamustine for Adjuvant Treatment of Glioblastoma", "OfficialTitle": "A Phase 1 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Tinostamustine, a Novel Alkylating and Deacetylase Inhibiting Molecule, as Adjuvant Treatment in Patients With Newly Diagnosed Unmethylated MGMT-promoter Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-07-01", "PrimaryCompletionDate": "2024-11-10", "Interventions": [ { "Name": "Tinostamustine", "Type": "DRUG", "Description": "infusion given over 60 minutes", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mundipharma Research Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02067156", "BriefTitle": "Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 (Mipsagargin) in Patients With Recurrent or Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "G-202", "Type": "DRUG", "Description": "G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity", "OtherNames": [ "Mipsagargin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "GenSpera, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Food and Drug Administration (FDA)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03787056", "BriefTitle": "Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients", "OfficialTitle": "Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2018-12-04", "PrimaryCompletionDate": "2028-01-04", "Interventions": [ { "Name": "Blood draws", "Type": "OTHER", "Description": "Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered :\n\n* Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit\n* Chemotherapy treatment : every 3 or 4 weeks\n* Radiotherapy : start day and at the end of radiation (\"end of treatment\" visit)\n* Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion\n* In case of PD or TOX\n* Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years\n* Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hospices Civils de Lyon", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01637753", "BriefTitle": "Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma", "OfficialTitle": "Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2012-06", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "Carmustine(BCNU)", "Type": "DRUG", "Description": "Carmustine Sustained Release Implant", "OtherNames": [ "BCNU" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Routine tumor resection surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Shandong Lanjin Pharmaceuticals Co.,Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003301", "BriefTitle": "Irinotecan in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Dose Finding and Safety/Efficacy Trial of CPT-11 (Irinotecan) in Patients With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1998-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03018288", "BriefTitle": "Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)", "OfficialTitle": "A Randomized, Double Blind Phase II Trial of Surgery, Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2017-09-21", "PrimaryCompletionDate": "2022-12-20", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab at 200mg will be administered on day 1 as a 30-minute intravenous (IV) infusion (prior to radiation therapy (RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with heat shock protein peptide complex -96 (HSPPC 96) or placebo vaccine if any is available.", "OtherNames": [ "Keytruda" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "HSPPC-96", "Type": "BIOLOGICAL", "Description": "One week post RT, patients will receive weekly x 4 a dose of heat shock protein peptide complex -96 (HSPPC 96) 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of temozolomide (TMZ). HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Participants who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.", "OtherNames": [ "heat shock protein peptide complex -96 (HSPPC 96)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) will be administered on day 1 of radiation therapy (before radiation therapy (RT) treatment) and continue throughout RT at the dose of 75 mg/m\\^2. Post RT: The starting TMZ dose will be 150 mg/m\\^2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m\\^2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "One week post radiation therapy (RT), participants will receive weekly x 4 a dose of heat shock protein peptide complex -96 (HSPPC 96) 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of Temozolomide (TMZ). HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Participants who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if participants are doing well, they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Tissue for vaccine production and neo-epitope monitoring.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00272870", "BriefTitle": "Treatment of Newly Diagnosed Brain Tumors With Chemotherapy and Radiation Using Cells Modified for Chemoprotection and an Experimental Drug to Decrease the Tumor Cell Resistance to Chemotherapy", "OfficialTitle": "A Pilot Study of Temozolomide and 06Benzylguanine for Treatment of Newly Diagnosed High Grade Glioma, Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2005-12", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "06Benzylguanine", "Type": "DRUG", "Description": "120 mg/m2/day; given Day 1-5 for up to 6 courses in Block 3", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "MGMT P140K", "Type": "GENETIC", "Description": "Gene manipulated cells, patients are not expected to receive greater than approximately 10 x 10e6 transduced CD34+ cells/kg", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Meltenyi CliniMacs", "Type": "DEVICE", "Description": "Device used for CD34+ cell separation of peripheral collection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Hospital Medical Center, Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02511405", "BriefTitle": "A Phase 3, Pivotal Trial of VB-111 Plus Bevacizumab vs. Bevacizumab in Patients With Recurrent Glioblastoma (GLOBE)", "OfficialTitle": "A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2015-08", "PrimaryCompletionDate": "2017-11-03", "Interventions": [ { "Name": "VB-111 + bevacizumab", "Type": "DRUG", "Description": "VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months\n\nBevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Vascular Biogenics Ltd. operating as VBL Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00115453", "BriefTitle": "Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma", "OfficialTitle": "Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1999-05", "PrimaryCompletionDate": "2008-08", "Interventions": [ { "Name": "irradiation", "Type": "RADIATION", "Description": "Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boneca Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00016328", "BriefTitle": "CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-05", "PrimaryCompletionDate": "2005-08", "Interventions": [ { "Name": "temsirolimus", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CCI-779", "cell cycle inhibitor 779", "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT02490800", "BriefTitle": "Phase 1/2a Study of Oral BAL101553 in Adult Patients With Solid Tumors or Glioblastoma or High-grade Glioma", "OfficialTitle": "An Open-label Phase 1/2a Study of Oral BAL101553 in Adult Patients With Advanced Solid Tumors and in Adult Patients With Recurrent or Progressive Glioblastoma or High-grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-05-20", "PrimaryCompletionDate": "2022-09-30", "Interventions": [ { "Name": "Lisavanbulin Phase 1 dose escalation portion", "Type": "DRUG", "Description": "Lisavanbulin hard capsules, containing 1 mg or 5 mg study drug, were given orally to fasted patients once daily in the dose range of 2 to 35 mg/day", "OtherNames": [ "BAL101553" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lisavanbulin Phase 2a expansion portion", "Type": "DRUG", "Description": "Recommended Phase 2 dose (RP2D) of 25 mg/day lisavanbulin hard capsules containing 5 mg study drug was administered once daily.", "OtherNames": [ "BAL101553" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Basilea Pharmaceutica", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04327011", "BriefTitle": "A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511", "OfficialTitle": "A Continuation Protocol for Patients Previously Enrolled in a Study of Toca 511", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-02", "PrimaryCompletionDate": "2019-12", "Interventions": [ { "Name": "Toca 511 vector", "Type": "BIOLOGICAL", "Description": "Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector", "OtherNames": [ "vocimagene amiretrorepvec", "RRV", "retroviral replicating virus" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine", "Type": "DRUG", "Description": "Toca FC is an extended-release formulation of flucytosine.", "OtherNames": [ "Extended Release 5-FC", "5-FC", "5-Fluorocytosine" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03291977", "BriefTitle": "Interest of Fluorescein in Fluorescence-guided Resection of Gliomas (FLEGME)", "OfficialTitle": "Interest of Fluorescein in Fluorescence-guided Resection of Gliomas: A Randomized Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2017-10-05", "PrimaryCompletionDate": "2022-01-18", "Interventions": [ { "Name": "Fluorescéine Sodique Faure", "Type": "DRUG", "Description": "Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "White-light surgery", "Type": "PROCEDURE", "Description": "The surgery will be performed under classical conditions", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rennes University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02466828", "BriefTitle": "qBOLD MRI of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.", "OfficialTitle": "Quantitative Blood Oxygenation Level Dependent (qBOLD) MR Imaging of Glioblastoma Multiforme for Assessment of Tumor Hypoxia.", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2015-03", "PrimaryCompletionDate": "2018-04", "Interventions": [ { "Name": "Feraheme®", "Type": "DRUG", "Description": "Drug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition.", "OtherNames": [ "ferumoxytol" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sunnybrook Health Sciences Centre", "LeadSponsorClass": "OTHER", "Collaborators": [ "Unity Health Toronto" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00892931", "BriefTitle": "Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-04", "PrimaryCompletionDate": "2011-07", "Interventions": [ { "Name": "Azixa", "Type": "DRUG", "Description": "3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)", "OtherNames": [ "MPC-6827" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Myrexis Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03581292", "BriefTitle": "Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27M or BRAFV600 Mutations", "OfficialTitle": "A Phase 2 Study of Veliparib (ABT-888) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients With Newly Diagnosed High-Grade Glioma (HGG) Without H3 K27M or BRAFV600 Mutations", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-11-06", "PrimaryCompletionDate": "2023-03-31", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Veliparib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ABT 888", "ABT-888", "ABT888", "PARP-1 inhibitor ABT-888" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "PARP" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MET", "PARP" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02149459", "BriefTitle": "Treatment of Recurrent Brain Tumors: Metabolic Manipulation Combined With Radiotherapy", "OfficialTitle": "Improving the Response of Recurrent Glioma to Radiation Therapy Through Metabolic Intervention", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2014-06", "PrimaryCompletionDate": "2018-07", "Interventions": [ { "Name": "Partial brain re-irradiation.", "Type": "RADIATION", "Description": "Partial brain re-irradiation to a dose of 30-35Gy delivered over 2 weeks (10 fractions).", "OtherNames": [ "radiotherapy", "radiation therapy (RT)", "fractionated stereotactic radiation (FSR)", "hypo-fractionated radiation therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Metformin", "Type": "DRUG", "Description": "Different cohorts will receive no, low dose or higher dose metformin.", "OtherNames": [ "glucophage", "antidiabetic drug", "biguanide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "low carbohydrate diet", "Type": "BEHAVIORAL", "Description": "Under close supervision of a dietician, patients will receive a low carbohydrate diet, enriched as necessary with medium chain triglyceride (MCT) supplements.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sheba Medical Center", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "European Union" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06804655", "BriefTitle": "Pharmacoscopy for Patients With Refractory Primary Brain Tumors", "OfficialTitle": "Pharmacoscopy for Patients With Refractory Primary Brain Tumors", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2026-02-12", "PrimaryCompletionDate": "2028-09-15", "Interventions": [ { "Name": "Pharmacoscopy 1.0", "Type": "DEVICE", "Description": "The intervention is the submission of freshly obtained surgical material to ex vivo drug profiling which we term pharmacoscopy (PCY). The performance study is interventional as the test results shall influence patient management decisions and/or may be used to guide treatment.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [ "University Hospital, Zürich", "University Hospital, Basel, Switzerland", "Cantonal Hospital of St. Gallen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02644291", "BriefTitle": "Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors", "OfficialTitle": "Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-05", "PrimaryCompletionDate": "2022-06-09", "Interventions": [ { "Name": "Mebendazole", "Type": "DRUG", "Description": "chewable mebendazole tablets that can also be crushed and mixed with food or drink to be taken daily with meals", "OtherNames": [ "Vermox", "Ovex", "Pripsen" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01308684", "BriefTitle": "A Dose- and Efficacy-Finding Study of RO5323441 in Combination With Avastin (Bevacizumab) in Patients With Recurrent Glioblastoma", "OfficialTitle": "Open-label, Combined Dose-finding (Phase I) and Efficacy-finding (Phase II) Study of RO5323441 in Combination With Bevacizumab for Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2013-02", "Interventions": [ { "Name": "RO5323441 + bevacizumab [Avastin]", "Type": "DRUG", "Description": "Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab [Avastin]", "Type": "DRUG", "Description": "Efficacy-Finding part: 10 mg/kg intravenously once every two weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03344250", "BriefTitle": "Phase I EGFR BATs in Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I Study Targeting Newly Diagnosed Glioblastoma With Anti-CD3 × Anti-EGFR Bispecific Antibody Armed T Cells (EGFR BATs) in Combination With Radiation and Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-03-01", "PrimaryCompletionDate": "2021-12-08", "Interventions": [ { "Name": "EGFR BATs with TMZ following SOC RT/TMZ", "Type": "DRUG", "Description": "Standard of care: 6 weeks of RT and TMZ and 6 cycles of TMZ (150-200 mg/m2) on days 1-5 of each 28 day cycle Experimental: EGFR BATs 2 and 3 weeks after completing RT, and then on day 21 of each cycle of TMZ.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Weekly EGFR BATs following SOC RT/TMZ", "Type": "DRUG", "Description": "Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Virginia", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00005955", "BriefTitle": "Temozolomide Followed by Radiation Therapy in Treating Children With Newly Diagnosed Malignant CNS Tumors", "OfficialTitle": "Phase II Treatment of Children With Newly Diagnosed Malignant Central Nervous System Tumors With Temozolomide Prior to Radiation Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-08", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05201326", "BriefTitle": "Irinotecan And Bevacizumab Combined With Re-radiotherapy in Recurrent Glioblastoma", "OfficialTitle": "An Open and Single-arm Prospective Clinical Study of the Safety and Efficacy of Irinotecan and Bevacizumab Combined With Re-radiotherapy in the Treatment of Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2021-12-22", "PrimaryCompletionDate": "2022-12-20", "Interventions": [ { "Name": "Bevacizumab，Irinotecan and Re-radiotherapy", "Type": "DRUG", "Description": "All patients with recurrent glioblastoma will accept irinotecan and bevacizumab combined with re-radiotherapy .", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Ruijin Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00689221", "BriefTitle": "Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Methylated Gene Promoter Status", "OfficialTitle": "Cilengitide for Subjects With Newly Diagnosed Glioblastoma and Methylated MGMT Gene Promoter - A Multicenter, Open-label, Controlled Phase III Study, Testing Cilengitide in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy) Versus Standard Treatment Alone (CENTRIC)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2008-09", "PrimaryCompletionDate": "2012-11", "Interventions": [ { "Name": "Cilengitide", "Type": "DRUG", "Description": "Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) 75 milligram per square meter \\[mg/m\\^2\\] will be administered intravenously once daily from Weeks 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Radiotherapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Weeks 1 to 6, total dose 60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "EMD Serono", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "European Organisation for Research and Treatment of Cancer - EORTC", "Merck KGaA, Darmstadt, Germany" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02315534", "BriefTitle": "A Study of BBI608 in Combination With Temozolomide in Adult Patients With Recurrent or Progressed Glioblastoma", "OfficialTitle": "A Phase Ib/II Clinical Study of BBI608 in Combination With Temozolomide for Adult Patients With Recurrent or Progressed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-03", "PrimaryCompletionDate": "2018-10-09", "Interventions": [ { "Name": "BBI608", "Type": "DRUG", "Description": "In arm A, BBI608 will be administered at the recommended Phase 2 dose (RP2D) twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide.\n\nIn arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the RP2D in combination with temozolomide.", "OtherNames": [ "Napabucasin", "BB608", "BBI-608" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) will be administered orally, once daily, at a dose of 150 mg/m\\^2 daily on days 1 through 5 of each 28-day study cycle. The dose of temozolomide can be increased to 200 mg/m\\^2 as per standard TMZ dosing guidelines for patients who complete at least one cycle at 150 mg/m\\^2.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sumitomo Pharma America, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05297864", "BriefTitle": "PARP Inhibition for Gliomas (PI-4G or π4g)", "OfficialTitle": "Phase II Trial of Niraparib in Patients With Recurrent Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2022-06-09", "PrimaryCompletionDate": "2023-11-14", "Interventions": [ { "Name": "Niraparib", "Type": "DRUG", "Description": "The starting dose will be 300 mg niraparib (or modified according patient weight and platelet count), taken orally once a day for each cycle of 28 days.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } } ], "LeadSponsorName": "University of Oklahoma", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "NCTId": "NCT03961971", "BriefTitle": "Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM", "OfficialTitle": "A Phase I Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-02-18", "PrimaryCompletionDate": "2022-11-16", "Interventions": [ { "Name": "MBG453", "Type": "DRUG", "Description": "Patients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "OtherNames": [ "spartalizumab", "stereotactic radiosurgery" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT03115138", "BriefTitle": "Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.", "OfficialTitle": "Evaluation of Circulating Tumor DNA as a Theranostic Marker in the Management of Glioblastomas.", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2016-03-09", "PrimaryCompletionDate": "2017-11-06", "Interventions": [ { "Name": "Correlation between molecular anomalies of the primary tumor and circulating tumor DNA", "Type": "OTHER", "Description": "The presence of a specific abnormality initially identified on the primary tumor and which can be quantified in the cDNA during the management will allow a better follow-up of the patient.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire, Amiens", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03341806", "BriefTitle": "Avelumab With Laser Interstitial Therapy for Recurrent Glioblastoma", "OfficialTitle": "Phase I Study of PD-L1 Inhibition With Avelumab and Laser Interstitial Thermal Therapy in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-06-13", "PrimaryCompletionDate": "2021-10-13", "Interventions": [ { "Name": "Avelumab", "Type": "DRUG", "Description": "Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "MRI-guided LITT therapy", "Type": "COMBINATION_PRODUCT", "Description": "(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Icahn School of Medicine at Mount Sinai", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT01851733", "BriefTitle": "MRI-Guided Laser Surgery and Doxorubicin Hydrochloride in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Doxorubicin in the Treatment of Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-08-13", "PrimaryCompletionDate": "2018-04-12", "Interventions": [ { "Name": "MRI-guided Laser Heat Ablation (MLA)", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Doxorubicin", "Type": "DRUG", "Description": null, "OtherNames": [ "Adriamycin®" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Blood draw - dendritic cells", "Type": "OTHER", "Description": "The second 10 patients enrolled to Arm B:\n\n* before MLA (up to 3 days before)\n* 2 weeks after MLA\n* 4 weeks after MLA\n* every 2 weeks thereafter for up to 3 months after biopsy (provided there is no significant chemotherapy induced cytopenia)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dynamic Susceptibility Contrast Magnetic Resonance Imaging", "Type": "DEVICE", "Description": null, "OtherNames": [ "DSC-MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "The Foundation for Barnes-Jewish Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05131815", "BriefTitle": "The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors", "OfficialTitle": "The BurnAlong Pilot Study: Examining the Feasibility of a Virtual Group-based Physical Activity Intervention for Adolescent and Young Adult Cancer Survivors", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2022-07-25", "PrimaryCompletionDate": "2023-06-15", "Interventions": [ { "Name": "Virtual group based physical activity (BurnAlong) and Social Media Discussion Board", "Type": "BEHAVIORAL", "Description": "Participants will engage in two to three virtual physical activity sessions a week through the BurnAlong app for three months with a chosen partner and participate at least twice a week in the research team-mediated social media message board. Additionally, participants will be asked to participate in one live physical activity session per month with an exercise physiologist.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cedars-Sinai Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Walter Reed National Military Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05663125", "BriefTitle": "LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas", "OfficialTitle": "Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-12-01", "PrimaryCompletionDate": "2023-12-01", "Interventions": [ { "Name": "Laser interstitial thermal therapy", "Type": "PROCEDURE", "Description": "Ablation of the tumor will be done by MRI-guided laser interstitial thermal therapy with the assistance of neuro-navigation.", "OtherNames": [ "LITT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered continuously from the 1st to the 21st day after LITT surgery. The oral dose of temozolomide is 75 mg/m2. And then, it will be given at a routine dose from the second month after surgery.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04732065", "BriefTitle": "ONC206 for Treatment of Newly Diagnosed, Recurrent Diffuse Midline Gliomas, and Other Recurrent Malignant CNS Tumors", "OfficialTitle": "Open Label Phase 1 and Target Validation Study of ONC206 in Children and Young Adults With Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-08-23", "PrimaryCompletionDate": "2027-05-31", "Interventions": [ { "Name": "ONC206", "Type": "DRUG", "Description": "Given orally (PO)", "OtherNames": [ "antagonist of dopamine receptor D2 (DRD2) /human mitochondrial caseinolytic protease P (ClpP)ClpP Agonist", "DRD2 antagonist/ClpP agonist" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standard of Care Radiation Therapy", "Type": "RADIATION", "Description": "Undergo RT", "OtherNames": [ "Radiation Therapy (RT)", "Cancer Radiotherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Optional Proton (1H) MR spectroscopy (MRS)", "Type": "PROCEDURE", "Description": "Optional imaging procedure", "OtherNames": [ "MRS" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sabine Mueller, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Jazz Pharmaceuticals", "Mithil Prasad Foundation", "Storm the Heavens Fund", "The ChadTough Defeat DIPG Foundation", "National Cancer Institute (NCI)", "Dana-Farber Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05979064", "BriefTitle": "Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)", "OfficialTitle": "Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-04-04", "PrimaryCompletionDate": "2025-04", "Interventions": [ { "Name": "Laparoscopically harvested omental tissue autograft", "Type": "PROCEDURE", "Description": "1. Standard neurosurgical removal of recurrent GBM,\n2. removal of fat from abdomen called omentum using a thin tube with a camera (laparoscopically),\n3. the omental fat will be transferred and implanted into brain tumor cavity,\n4. standard closure of surgical resection cavity.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00002619", "BriefTitle": "Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Glioblastoma Multiforme or Brain Stem Tumors", "OfficialTitle": "A TRIAL OF INTENSIVE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL RECONSTITUTION FOR PATIENTS BETWEEN SIX AND SIXTY YEARS OF AGE, WITH NON-PROGRESSIVE GLIOBLASTOMA MULTIFORME OR DIFFUSE INTRINSIC BRAINSTEM TUMORS, FOLLOWING INITIAL LOCAL-FIELD IRRADIATION", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1994-09", "PrimaryCompletionDate": "2000-04", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00611728", "BriefTitle": "Ph I SU011248 + Irinotecan in Treatment of Pts w MG", "OfficialTitle": "A Phase I Study of SU011248 Plus Irinotecan in the Treatment of Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-03", "PrimaryCompletionDate": "2010-06", "Interventions": [ { "Name": "SU011248 & Irinotecan", "Type": "DRUG", "Description": "Sutent given in daily oral manner for 1st 4 wks of each 6wk cycle. You will not take any Sutent during last 14 days of each 6 wk cycle. CPT-11 will be given intravenously over 1 \\& 1/2 hrs on 1st day of each cycle \\& then again on days 14 \\& 28.\n\nSutent is approved for adult subjects w some forms of kidney cancer. It is considered \"investigational\" for brain tumors. Dosing will begin on day 1 of cycle 1 \\& continue daily for 4 wks by mouth.\n\nIrinotecan is approved for adult subjects with some forms of colorectal cancer. It is also considered \"investigational\" for brain tumors. Irinotecan dose will depend on your height \\& weight. Irinotecan will be given intravenously over 90 min on days 1, 14 \\& 28 of 6wk cycle.\n\nYou will be seen in clinic approximately every 42 days for 1st 3 cycles of study drug, \\& then every other cycle thereafter. Your brain MRI examination will be done within 1 wk prior to completion of cycles 1-3, \\& then within 1 week prior to completion of every other cycle.", "OtherNames": [ "SU011248-Sutent-Sunitinib", "Irinotecan-CPT 11-Camptosar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02781792", "BriefTitle": "Temozolomide Chronotherapy for High Grade Glioma", "OfficialTitle": "A Randomized Feasibility Study Evaluating Temozolomide Chronotherapy for High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-08-11", "PrimaryCompletionDate": "2024-07-18", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "-Given standard of care", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Functional Assessment of Cancer Therapy - Brain", "Type": "OTHER", "Description": "* 23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire \\[2\\] that includes 27 items.\n* Patients rate all 5 items using a five-point Likert scale ranging from 0 \"not at all\" to 4 \"very much.\" Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items)\n* The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia.", "OtherNames": [ "FACT-Br" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "ActTrust Condor Instrument Watch", "Type": "OTHER", "Description": "-Will be required to wear 24 hours per day and will only be removed at specified data collection time points", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00021307", "BriefTitle": "Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Trial Of Temozolomide And Carboplatin In Recurrent Glioblastoma Multiforme", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": null, "PrimaryCompletionDate": "2002-04", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Fox Chase Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01836536", "BriefTitle": "Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients", "OfficialTitle": "Analysis of Different Circulating Immune Cells in Patients With Recurrent Glioblastoma or Mixed Anaplasic Glioma Treated With Bevacizumab and Search for a Link With Response to Treatment", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2012-09", "PrimaryCompletionDate": "2015-03", "Interventions": [ { "Name": "Bevacizumab standard of care", "Type": "DRUG", "Description": "Standard treatment associated with circulating leucocytes (blood samplings)", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Center Eugene Marquis", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00039468", "BriefTitle": "Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy", "OfficialTitle": "A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-03", "PrimaryCompletionDate": "2007-09", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": "350 or 700 mg/m2 IV every 3 weeks", "OtherNames": [ "CAMPTOSAR" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thalidomide", "Type": "DRUG", "Description": "400mg/day oral", "OtherNames": [ "THALOMID" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05879120", "BriefTitle": "Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma", "OfficialTitle": "Randomized Study of Neo-adjuvant and Adjuvant Pembrolizumab With and Without Targeted Blood Brain Barrier Opening Using Exablate MRI-guided Focused Ultrasound (Exablate MRgFUS) for Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2024-07-30", "PrimaryCompletionDate": "2024-10-02", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Given by IV (vein)", "OtherNames": [ "Keytruda", "MK-3475", "SCH-900475" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Exablate MRgFUS + neoadjuvant pembolizumab", "Type": "DEVICE", "Description": "Given by IV (vein)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "InSightec", "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT05187624", "BriefTitle": "A Study Evaluating the Safety, Pharmacokinetic and Anti-tumor Activity of RO7428731 in Participants With Glioblastoma", "OfficialTitle": "An Open-label, Multicenter, Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7428731 in Participants With Glioblastoma Expressing Mutant Epidermal Growth Factor Receptor Variant III", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-04-05", "PrimaryCompletionDate": "2025-05-14", "Interventions": [ { "Name": "RO7428731", "Type": "DRUG", "Description": "Participants will receive RO7428731 as described.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT03919071", "BriefTitle": "Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma", "OfficialTitle": "A Phase 2 Study of Dabrafenib (NSC# 763760) With Trametinib (NSC# 763093) After Local Irradiation in Newly-Diagnosed BRAF V600-Mutant High-Grade Glioma (HGG)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-02-20", "PrimaryCompletionDate": "2027-09-30", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo collection of blood", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Dabrafenib Mesylate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Dabrafenib Methanesulfonate", "GSK2118436 Methane Sulfonate Salt", "GSK2118436B", "Tafinlar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lumbar Puncture", "Type": "PROCEDURE", "Description": "Undergo lumbar puncture", "OtherNames": [ "LP", "Spinal Tap" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo RT", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Trametinib Dimethyl Sulfoxide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Mekinist", "Meqsel", "Spexotras" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02186509", "BriefTitle": "Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas", "OfficialTitle": "Phase I Study of Alisertib With Concurrent Fractionated Stereotactic Radiation Treatment for Recurrent High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-01-30", "PrimaryCompletionDate": "2017-03-31", "Interventions": [ { "Name": "Hyperfractionated radiation therapy", "Type": "RADIATION", "Description": "Undergo hyperfractionated radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic radiosurgery", "Type": "RADIATION", "Description": "Undergo stereotactic radiosurgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Alisertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "MLN8237" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-life assessment", "Type": "PROCEDURE", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Cancer Center at Thomas Jefferson University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Millennium Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01349036", "BriefTitle": "A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 2 Study of Orally Administered PLX3397 in Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-12-03", "PrimaryCompletionDate": "2013-11-05", "Interventions": [ { "Name": "PLX3397", "Type": "DRUG", "Description": "Capsules administered once or twice daily, continuous dosing", "OtherNames": [ "Pexidartinib" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Daiichi Sankyo", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Plexxikon" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00869401", "BriefTitle": "Dasatinib or Placebo, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined With Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2014-10", "Interventions": [ { "Name": "dasatinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "placebo", "Type": "OTHER", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Radiation therapy is performed as 30 fractions of 200 cGy for a total of 6000 cGy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT05773664", "BriefTitle": "Dexamethasone and Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma", "OfficialTitle": "A Phase I De-Escalation Study of Dexamethasone with Azeliragon for Management of Post-Resection Cerebral Edema in Patients with Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2024-11-15", "PrimaryCompletionDate": "2024-11-29", "Interventions": [ { "Name": "Azeliragon", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo collection of cavity fluid and blood samples", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT scan", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized Tomography", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Dexamethasone", "Type": "DRUG", "Description": "Given PO or IV", "OtherNames": [ "Aacidexam", "Adexone", "Aknichthol Dexa", "Alba-Dex", "Alin", "Alin Depot", "Alin Oftalmico", "Amplidermis", "Anemul mono", "Auricularum", "Auxiloson", "Baycadron", "Baycuten", "Baycuten N", "Cortidexason", "Cortisumman", "Decacort", "Decadrol", "Decadron", "Decadron DP", "Decalix", "Decameth", "Decasone R.p.", "Dectancyl", "Dekacort", "Deltafluorene", "Deronil", "Desamethasone", "Desameton", "Dexa-Mamallet", "Dexa-Rhinosan", "Dexa-Scheroson", "Dexa-sine", "Dexacortal", "Dexacortin", "Dexafarma", "Dexafluorene", "Dexalocal", "Dexamecortin", "Dexameth", "Dexamethasone Intensol", "Dexamethasonum", "Dexamonozon", "Dexapos", "Dexinoral", "Dexone", "Dinormon", "Dxevo", "Fluorodelta", "Fortecortin", "Gammacorten", "Hemady", "Hexadecadrol", "Hexadrol", "Lokalison-F", "Loverine", "Methylfluorprednisolone", "Millicorten", "Mymethasone", "Orgadrone", "Spersadex", "TaperDex", "Visumetazone", "ZoDex" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging of the Brain with and without Contrast", "Type": "PROCEDURE", "Description": "Undergo MRI with or without contrast", "OtherNames": [ "Brain Magnetic Resonance Imaging with and without Contrast", "Brain MRI", "Brain MRI with and without Contrast", "Head MRI with and without Contrast" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00003348", "BriefTitle": "Carmustine Plus O(6)-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain", "OfficialTitle": "Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent, Persistent or Progressive Cerebral Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-05", "PrimaryCompletionDate": "2000-08", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03027388", "BriefTitle": "Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma", "OfficialTitle": "Phase II Trial of LB100, a Protein Phosphatase 2A Inhibitor, in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2019-01-09", "PrimaryCompletionDate": "2022-08-15", "Interventions": [ { "Name": "LB-100", "Type": "DRUG", "Description": "LB-100 will be infused over 2 hours via intravenous (IV) infusion 2 to 4 hours before surgery. The dose established from a Phase I study will be 2.33 mg/m\\^2.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02722512", "BriefTitle": "Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine", "OfficialTitle": "A Phase I and Feasibility Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Pediatric Patients With Newly Diagnosed Intracranial High Grade Glioma and Recurrent Resectable Intracranial High Grade Glioma and Ependymoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2016-07", "PrimaryCompletionDate": "2019-11-13", "Interventions": [ { "Name": "Heat Shock Protein Peptide Complex-96 (HSPPC-96)", "Type": "BIOLOGICAL", "Description": "The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor Resection", "Type": "PROCEDURE", "Description": "Clinically-indicated removal of the tumor", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Focal Radiation Therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ann & Robert H Lurie Children's Hospital of Chicago", "LeadSponsorClass": "OTHER", "Collaborators": [ "Northwestern University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00290771", "BriefTitle": "Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase II, Open-label, Multicenter Study Evaluating the Efficacy of Imatinib Plus Hydroxyurea (HU) in Patients With Progressive Glioblastoma Multiforme (GBM) Receiving or Not Receiving Enzyme-inducing Anticonvulsant Drugs (EIACDs)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2006-02", "PrimaryCompletionDate": "2008-08", "Interventions": [ { "Name": "Imatinib tablets", "Type": "DRUG", "Description": "Imatinib was supplied as 100 and 400 mg tablets by Novartis.", "OtherNames": [ "Glivec®" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Hydroxyurea capsules", "Type": "DRUG", "Description": "Hydroxyurea was supplied locally as 500 mg capsules.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01587144", "BriefTitle": "Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)", "OfficialTitle": "An International, Multi-Center, Randomized, Double Blind Placebo Controlled Phase II Study to Evaluate the Safety and Efficacy of Lucanthone Administered as an Adjunct to Radiation and Temozolomide for Primary Therapy of Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2012-06-19", "PrimaryCompletionDate": "2013-04-15", "Interventions": [ { "Name": "Lucanthone", "Type": "DRUG", "Description": "Lucanthone will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "TMZ is administered at 75mg/m2 daily for 42 days during the concomitant phase. TMZ is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.\n\nCycles 2-6: At the start of Cycle 2, the dose can be escalated to 200 mg/m2, if the common terminology criteria (CTC) nonhematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count (ANC) is ≥1.5 x 109/L, and the platelet count is ≥100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "60 Gy administered in 30 fractions for 42 days in the concomitant phase.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Placebo will be given as an oral at 10-15 mg/kg/day for 6 weeks during the concomitant phase. In the maintenance phase, placebo will be administered on days 1-5 of a 28-day cycle for 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Spectrum Pharmaceuticals, Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00070525", "BriefTitle": "Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma", "OfficialTitle": "A Phase II Study of R115777 (Zarnestra) (NSC # 702818, IND# 58,359) in Children With Recurrent or Progressive: High Grade Glioma, Medulloblastoma/PNET or Brainstem Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-11", "PrimaryCompletionDate": "2006-09", "Interventions": [ { "Name": "tipifarnib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01656980", "BriefTitle": "Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma", "OfficialTitle": "Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2012-08", "PrimaryCompletionDate": "2014-08", "Interventions": [ { "Name": "Carmustine", "Type": "DRUG", "Description": "As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.", "OtherNames": [ "Trade name: CASANT", "Other name: BCNU" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "tumor resection surgery", "Type": "PROCEDURE", "Description": "For this group, subjects will accept routine tumor resection surgery and place no implant wafers.", "OtherNames": [ "blank control group" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Shandong Lanjin Pharmaceuticals Co.,Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00979862", "BriefTitle": "Cediranib Maleate and Cilengitide in Treating Patients With Progressive or Recurrent Glioblastoma", "OfficialTitle": "A Phase Ib Study of Cediranib in Combination With Cilengitide in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-03", "PrimaryCompletionDate": "2012-05", "Interventions": [ { "Name": "Cediranib Maleate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD2171", "AZD2171 Maleate", "Recentin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974", "EMD-121974" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05565118", "BriefTitle": "Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression", "OfficialTitle": "Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma (WHO Grade III and IV) as a Predictor of Progression", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-04-09", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Standard Surgical Treatment", "Type": "PROCEDURE", "Description": "During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intraoperative Electrocorticography", "Type": "PROCEDURE", "Description": "Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Burkhardt Brain Tumor and Neuro-Oncology Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04295759", "BriefTitle": "INCB7839 in Treating Children With Recurrent/Progressive High-Grade Gliomas", "OfficialTitle": "A Phase I Study of the Adam-10 Inhibitor, INCB7839 in Children With Recurrent/Progressive High-Grade Gliomas to Target Microenvironmental Neuroligin-3", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2020-07-27", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "INCB7839", "Type": "DRUG", "Description": "INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)", "American Lebanese Syrian Associated Charities" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00352313", "BriefTitle": "ATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase I/II Study of ATN-161 and Carboplatin in Adult Patients With Recurrent Intracranial Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-05", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "ATN-161", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Institutes of Health Clinical Center (CC)", "LeadSponsorClass": "NIH", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00022724", "BriefTitle": "CCI-779 in Treating Patients With Malignant Glioma", "OfficialTitle": "Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-08-27", "PrimaryCompletionDate": "2006-05-04", "Interventions": [ { "Name": "temsirolimus", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT03115333", "BriefTitle": "DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma", "OfficialTitle": "Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2017-07-25", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging", "Type": "DIAGNOSTIC_TEST", "Description": "Undergo DSC-MRI", "OtherNames": [ "DSC-MRI", "Dynamic Susceptibility Contrast-Enhanced MRI", "DYNAMIC SUSCEPTIBILITY-CONTRAST MRI" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "ECOG-ACRIN Cancer Research Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02017249", "BriefTitle": "Efficacy Study of Oral Arginine to Improve Immune Function in Glioblastoma Multiforme", "OfficialTitle": "A Double-Blinded Randomized Placebo-Controlled Trial Exploring the Efficacy of Oral ARginine Supplementation to Improve Cellular Immune Function in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-03", "PrimaryCompletionDate": "2015-09", "Interventions": [ { "Name": "arginine in powder form", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Silica and cellulose placebo powder", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Inova Health Care Services", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03232424", "BriefTitle": "NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma", "OfficialTitle": "Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-07-26", "PrimaryCompletionDate": "2022-12-07", "Interventions": [ { "Name": "NovoTTF-200A", "Type": "DEVICE", "Description": "* Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.\n* Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter.", "OtherNames": [ "Optune" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concomitant phase:\n\n* 75 mg/m2 per day for 42 days concomitant with radiotherapy.\n* Begins 1 day prior to XRT start.\n\nMaintenance phase:\n\n* Begins 4 weeks after concomitant phase completion (+/- 1 week).\n* Each cycle is 28 days (5 days of drug treatment followed by 23 days without).\n* Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.\n* Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "3D conformal or intensity modulated radiation therapy (IMRT)", "Type": "RADIATION", "Description": "Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Hackensack Meridian Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00904852", "BriefTitle": "Safety Study of the Combination of Tandutinib With Temozolomide and Bevacizumab After Radiation and Temozolomide in Patients With Newly Diagnosed With Glioblastoma Multiforme", "OfficialTitle": "A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2010-05", "Interventions": [ { "Name": "Tandutinib, bevacizumab, and temozolomide", "Type": "DRUG", "Description": "All patients will have completed treatment with concurrent radiation therapy and temozolomide. Patients will be entered into different dosing groups of tandutinib. Patients will receive up to 6 cycles of treatment with oral temozolomide at 150 mg/m2 daily for the first 5 days of a 28 day cycle, oral tandutinib at escalating doses 250, 375, 500, or 625 mg twice daily on days 1 to 28, and intravenous bevacizumab at 10 mg/kg on days 1 and 15 of each cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Millennium Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT05600491", "BriefTitle": "A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme", "OfficialTitle": "A Phase III Study of Postoperative Early Temozolomide Treatment Plus STUPP Regimen for Newly Diagnosed GBM Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2015-11-08", "PrimaryCompletionDate": "2022-12-01", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Two weeks after surgery, temozolomide was administered orally at 200 mg·m-2 ·d -1 for 5 days. From day 29, patients were treated with a standard therapy regimen (Stupp).", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sun Yat-sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01861990", "BriefTitle": "Valproic Acid in Childhood Progressive Brain Tumors", "OfficialTitle": "Valproic Acid for Children With Recurrent and Progressive Brain Tumors", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "Valproic Acid", "Type": "DRUG", "Description": "All participants enrolled on valproic acid arm.", "OtherNames": [ "Valproate, VPA, Depakote, Depakote ER, Depakene" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical University of South Carolina", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00626015", "BriefTitle": "Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery", "OfficialTitle": "Zenapax®-Activated Peptide ImmunoTherapy [ZAP IT]", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-03", "PrimaryCompletionDate": "2013-02", "Interventions": [ { "Name": "PEP-3-KLH conjugate vaccine", "Type": "BIOLOGICAL", "Description": "Given intradermally", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "daclizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given by mouth.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "placebo", "Type": "OTHER", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PEP-3-KLH", "Type": "BIOLOGICAL", "Description": "Basiliximab 20 mg IV over 30 minutes with PEP-3-KLH vaccine # 1 only.", "OtherNames": [ "CDX-110", "EGFRvIII-KLH" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "John Sampson", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01234740", "BriefTitle": "Bafetinib in Treating Patients With Recurrent High-Grade Glioma or Brain Metastases", "OfficialTitle": "BAFETINIB-P1-GBM-01: A Pilot Study Using Intracerebral Microdialysis to Determine the Neuropharmacokinetics of Bafetinib in Patients With Recurrent Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2013-03", "Interventions": [ { "Name": "bafetinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "dual Bcr-Abl/Lyn tyrosine kinase inhibitor INNO-406", "INNO-406", "NS-187" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "microdialysis", "Type": "PROCEDURE", "Description": "Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "liquid chromatography", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "LC" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "mass spectrometry", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "protein expression analysis", "Type": "GENETIC", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "western blotting", "Type": "GENETIC", "Description": "Correlative studies", "OtherNames": [ "Blotting, Western", "Western Blot" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "immunohistochemistry" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "debulking craniotomy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03535350", "BriefTitle": "Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I Study of Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-08-24", "PrimaryCompletionDate": "2023-04-04", "Interventions": [ { "Name": "Ibrutinib", "Type": "DRUG", "Description": "Dose response of Ibrutinib. Level 1 starting dose is 420mg daily. Level 2 starting dose is 560mg daily. Level -1 starting dose is 280mg daily.\n\nNovember 2020:\n\n420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can betreated at the expansion cohort in both arm 1 and arm 2.", "OtherNames": [ "Imbruvica" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "2Gy x 30minutes for 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Cycle 1 150mg/m2 and cycle 2-6 will be up to 200mg/m2.", "OtherNames": [ "Temodar", "Methazolastone" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT02331498", "BriefTitle": "Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Study of Pazopanib in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme After Surgery and RT-CT", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-06", "PrimaryCompletionDate": "2027-02", "Interventions": [ { "Name": "Pazopanib", "Type": "DRUG", "Description": "Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Antoine Lacassagne", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00017147", "BriefTitle": "S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2001-09", "PrimaryCompletionDate": "2006-05", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": "40 mg/m\\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG.\n\n200 mg/m\\^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "O6-Benzylguanine", "Type": "DRUG", "Description": "120 mg/m\\^2 IV over 1 hour on day 1 of each cycle", "OtherNames": [ "O6-BG" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "SWOG Cancer Research Network", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00790452", "BriefTitle": "Aspirin Prophylaxis for Venous Thromboembolism in Glioblastoma", "OfficialTitle": "A Randomized Phase II Trial of Aspirin for Primary Prophylaxis of Venous Thromboembolism in Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2008-11", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "Aspirin", "Type": "DRUG", "Description": "325 mg daily by mouth", "OtherNames": [ "ASA" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Tablet daily by mouth", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05773326", "BriefTitle": "Superselective Intra-arterial Cerebral Infusion of Temsirolimus in HGG", "OfficialTitle": "A Phase 0, Single-center, Open-label, Dose-escalating Trial Using Super-selective Intra-arterial Infusion of a Single Dose of Temsirolimus for the Treatment of Recurrent High-grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-05-15", "PrimaryCompletionDate": "2026-05", "Interventions": [ { "Name": "Temsirolimus", "Type": "DRUG", "Description": "TORISEL® (temsirolimus) is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma.", "OtherNames": [ "Torisel" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Institute", "Ivy Brain Tumor Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02149225", "BriefTitle": "GAPVAC Phase I Trial in Newly Diagnosed Glioblastoma Patients", "OfficialTitle": "A Phase I Trial of Actively Personalized Peptide Vaccinations Plus Immunomodulators in Patients With Newly Diagnosed Glioblastoma Concurrent to First Line Temozolomide Maintenance Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-10", "PrimaryCompletionDate": "2018-06", "Interventions": [ { "Name": "APVAC1 vaccine plus Poly-ICLC and GM-CSF", "Type": "DRUG", "Description": "APVAC1 vaccines (i.d.) will be individually assembled for each patient and can be applied to the patient approx. 3 months after enrollment. APVAC1 drug products are composed of 5 to 10 peptides from the GAPVAC warehouse. The APVAC1 vaccine will be applied concurrent to maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 15 of the first maintenance TMZ cycle, patients will receive 11 vaccinations with APVAC1 drug products during 22 weeks. 578 μg per peptide per vial are used.\n\nPoly ICLC (1.5 mg s.c.) will be used as immunomodulator with all vaccinations except the second applications of APVAC1 (Day 2) and APVAC2 vaccines (Day 2\\*) to avoid dose accumulation on consecutive days.\n\nThe 2. immunomodulator GM-CSF (75 μg) will be applied i.d. with the first six vaccinations with both vaccines, APVAC1 and APVAC2. A total of 12 GM-CSF doses will be applied. GM-CSF will be applied to the APVAC vaccination site 10-30 min before injection of the APVACs.", "OtherNames": [ "Actively Personalized Vaccine", "Hiltonol", "Leukine" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "APVAC2 vaccine plus Poly-ICLC and GM-CSF", "Type": "DRUG", "Description": "APVAC2 vaccines (i.d.) will be ready for use ca. 6 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. APVAC2 drug products are composed of 1 or 2 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with APVAC2 drug products beginning on day 15 of the 4. maintenance TMZ cycle. Patients will receive 8 vaccinations within 10 weeks. 578 μg per peptide per vial are used.\n\nPoly-ICLC (1.5 mg s.c.) will be used as immunomodulator with all vaccinations except the second applications of APVAC1 (Day 2) and APVAC2 vaccines (Day 2\\*) to avoid dose accumulation on consecutive days.\n\nGM-CSF (75 μg) will be applied i.d. with the first six vaccinations with both vaccines, APVAC1 and APVAC2. A total of 12 GM-CSF doses will be applied. GM-CSF will be applied to the APVAC vaccination site 10-30 min before injection of the APVACs.", "OtherNames": [ "Actively Personalized Vaccine", "Hiltonol", "Leukine" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Immatics Biotechnologies GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "BioNTech SE", "University Hospital Tuebingen", "BCN Peptides", "EU-funded GAPVAC Consortium" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03782415", "BriefTitle": "Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma", "OfficialTitle": "Phase 1b/2a Single-center, Open-label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of MN-166 (Ibudilast) and Temozolomide Combination Treatment in Patients With Newly Diagnosed or Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-12-29", "PrimaryCompletionDate": "2023-08-07", "Interventions": [ { "Name": "MN-166", "Type": "DRUG", "Description": "MN-166 is an anti-inflammatory/neuroprotective agent. MN-166 distributes well to the CNS (Sanftner et al. 2009) and it is a selective inhibitor of certain cyclic nucleotide phosphodiesterases (PDE) and the pro-inflammatory cytokine, macrophage migration inhibitory factor (MIF). At clinically-relevant plasma or CNS concentrations, MN-166 selectively inhibits macrophage migration inhibitory factor (MIF) (Cho et al 2010) and, secondarily, PDE3, 4 and 10 (Gibson et al 2006).", "OtherNames": [ "ibudilast" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; and a first-line treatment for glioblastoma multiforme.", "OtherNames": [ "TMZ", "Temodar", "Temodal", "Temcad" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "MediciNova", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00115440", "BriefTitle": "BNCT to Treat Glioma That Has Progressed Following Radiotherapy", "OfficialTitle": "BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-03", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "Bononophenylalanine (BPA)-based BNCT", "Type": "RADIATION", "Description": "Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boneca Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02432417", "BriefTitle": "The Addition of Chloroquine to Chemoradiation for Glioblastoma,", "OfficialTitle": "A Phase II Randomized Controlled Trial for the Addition of Chloroquine, an Autophagy Inhibitor, to Concurrent Chemoradiation for Newly Diagnosed Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2023-11-10", "PrimaryCompletionDate": "2023-11-10", "Interventions": [ { "Name": "Chloroquine", "Type": "DRUG", "Description": "CQ will start with one week before the start of radiotherapy and end on the last day of radiotherapy.", "OtherNames": [ "A-CQ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Maastricht Radiation Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05303467", "BriefTitle": "A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM", "OfficialTitle": "FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-07-30", "PrimaryCompletionDate": "2026-03-31", "Interventions": [ { "Name": "TheraSphere GBM", "Type": "DEVICE", "Description": "Single treatment of TheraSphere GBM device", "OtherNames": [ "TheraSphere™ GBM Y-90 Glass Microspheres (TheraSphere GBM)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boston Scientific Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00267592", "BriefTitle": "Safety and Efficacy of Talampanel in Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-12", "PrimaryCompletionDate": "2008-09", "Interventions": [ { "Name": "Talampanel", "Type": "DRUG", "Description": "Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy (RT) 5 days a week +", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide(TMZ) 75mg", "Type": "DRUG", "Description": "temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant TMZ 200mg", "Type": "DRUG", "Description": "adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Teva Branded Pharmaceutical Products R&D, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00021229", "BriefTitle": "Imatinib Mesylate With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed or Recurrent Glioma", "OfficialTitle": "A Phase I/II Trial Of STI571 In Children With Newly Diagnosed Poor Prognosis Brainstem Gliomas And Recurrent Intracranial Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-05", "PrimaryCompletionDate": "2008-08", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": "* Phase 1 Stratum I: Starting dose level of 350 mg/m2/day every 28 days X 13 courses (dose escalation)\n* Phase I Stratum IIA: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)\n* Phase I Stratum IIB: Starting dose level of 465 mg/m2/day every 28 days X 13 courses (dose escalation)\n* Phase II: Phase I Stratum I determined dose (Maximum tolerated dose) every 28 days X 13 courses.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "local irradiation therapy", "Type": "RADIATION", "Description": "* Phase I Stratum I: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib.\n* Phase II: Total dose of 5580 cGy using conventional or conformal volume-based delivery techniques once daily, 5 days/week for six weeks prior to receiving imatinib.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT06501911", "BriefTitle": "A Study of Bicalutamide With Brain Re-irradiation to Treat Recurrent/Progressive High Grade Glioma", "OfficialTitle": "Phase I Dose Escalation Study on Bicalutamide, an Androgen Receptor Antagonist, as a Radiosensitizer Combining With Brain Re-irradiation to Treat Recurrent/Progressive Glioblastoma/High Grade Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2025-04-08", "PrimaryCompletionDate": "2025-07-17", "Interventions": [ { "Name": "Bicalutamide", "Type": "DRUG", "Description": "Participants will receive daily oral bicalutamide for six (6) months. The dose will be determined by the cohort to which the participant is enrolled as well as the toxicities experienced by previously enrolled cohorts.", "OtherNames": [ "Casodex" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intensity-modulated radiation therapy (IMRT)", "Type": "RADIATION", "Description": "Participants will receive 35 Gy delivered in 10 fractions, administered once daily on weekdays.", "OtherNames": [ "Three-Dimensional Conformal Radiation Therapy (3D-CRT)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Nebraska", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00575887", "BriefTitle": "Efficacy of Protracted Temozolomide in Patients With Progressive High Grade Glioma", "OfficialTitle": "Efficacy of a Protracted Temozolomide Schedule in Patients With Progression After Standard Dose Temozolomide for High-grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-08", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles. Number of cycles: Until progression or unacceptable toxicity", "OtherNames": [ "Temodal", "Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Marmara University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07244666", "BriefTitle": "Safety and Preliminary Efficacy of a Metabolically Armed Chimeric Antigen Receptor T Cell Therapy Targeting EGFRvIII for Recurrent Glioblastoma", "OfficialTitle": "Safety and Preliminary Efficacy of a Metabolically Armed Chimeric Antigen Receptor T Cell Therapy Targeting EGFRvIII for Recurrent Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-11-15", "PrimaryCompletionDate": "2027-12-31", "Interventions": [ { "Name": "Metabolically Armed EGFRvIII CAR-T cells", "Type": "DRUG", "Description": "Patients will receive a single infusion of Meta10-EGFRvIII.", "OtherNames": [ "Meta10-EGFRvIII", "LMC005" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Leman Biotech Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [] } }, { "NCTId": "NCT00967330", "BriefTitle": "A Study of Avastin (Bevacizumab) and Irinotecan Versus Temozolomide Radiochemistry in Patients With Glioblastoma", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-06", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "bevacizumab [Avastin]", "Type": "DRUG", "Description": "10mg/kg iv every 2 weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "irinotecan", "Type": "DRUG", "Description": "125mg/m2 iv every 2 weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00005081", "BriefTitle": "Carmustine Plus O6-benzylguanine in Treating Patients With Recurrent or Progressive Glioma", "OfficialTitle": "Phase II Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent or Progressive Cerebral Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-08", "PrimaryCompletionDate": "2001-04", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04854044", "BriefTitle": "ONC201 and Radiation Therapy Before Surgery for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "Phase 1b Study of ONC201 and Radiotherapy in Preoperative Recurrent Glioblastoma (GBM) Patients", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2021-05-01", "PrimaryCompletionDate": "2025-07-01", "Interventions": [ { "Name": "Akt/ERK Inhibitor ONC201", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "ONC201", "TIC10" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Surgical Resection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Oncoceutics, Inc.", "University of California, Los Angeles" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06815432", "BriefTitle": "GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma", "OfficialTitle": "GPC-3 Chimeric Antigen Receptor T Cells FOR Recurrent GPC-3 Positive Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-10-10", "PrimaryCompletionDate": "2029-12-05", "Interventions": [ { "Name": "15.GPC3-CAR T cells", "Type": "GENETIC", "Description": "Four different dosing schedules will be evaluated. The following dose levels will be evaluated:\n\nDL1: 5x10\\^6 DL2: 1x10\\^7 DL3: 5x10\\^7 DL4: 1x10\\^8", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Baylor College of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Center for Cell and Gene Therapy, Baylor College of Medicine", "Baylor St. Luke's Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05283109", "BriefTitle": "ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM", "OfficialTitle": "ETAPA I: Evaluation of Tumor Associated P30-Peptide Antigen I; A Pilot Trial of Peptide-based Tumor Associated Antigen Vaccines in Newly Diagnosed, Unmethylated, and Untreated Glioblastoma (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-08-30", "PrimaryCompletionDate": "2025-04-11", "Interventions": [ { "Name": "Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine", "Type": "BIOLOGICAL", "Description": "Vaccine that includes 3 peptides (EphA2 linked to P30 peptide, pp65 linked to P30 peptide, and Survivin linked to P30 peptide)", "OtherNames": [ "P30-EPS" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Hiltonol", "Type": "DRUG", "Description": "Hiltonol® is made up of synthetic (manmade) RNA (ribonucleic acid) and is used as an adjuvant to the vaccine, meaning it is used with the vaccine to stimulate or enhance the activation of your immune system.", "OtherNames": [ "poly-ICLC" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Mustafa Khasraw, MBChB, MD, FRCP, FRACP", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01576666", "BriefTitle": "Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors", "OfficialTitle": "A Phase Ib, Multi-center, Open Label, Dose Escalation Study of Oral LDE225 in Combination With BKM 120 in Patients With Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-07", "PrimaryCompletionDate": "2015-04", "Interventions": [ { "Name": "LDE225", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "BKM120", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00022256", "BriefTitle": "Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-04", "PrimaryCompletionDate": "2003-04", "Interventions": [ { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00610571", "BriefTitle": "Ph I Oral Topotecan and Temozolomide for Patients With Malignant Gliomas", "OfficialTitle": "Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-04", "PrimaryCompletionDate": "2009-09", "Interventions": [ { "Name": "Oral Topotecan and Temodar", "Type": "DRUG", "Description": "Temozolomide is taken by mouth once day, every day for 5 consecutive days at dose of 200 mg/m2/day.\n\nOral Topotecan will be taken daily for 5 consecutive days beginning 12-24 hrs after 1st dose of Temozolomide. Dose escalation of Oral Topotecan will be carried out in cohorts of 3 new subjects beginning w dose level 1 @ 0.75 mg/m2/dose.", "OtherNames": [ "Temodar - Temozolomide", "Topotecan - Hycamtin" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Katy Peters", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00002814", "BriefTitle": "Combination Chemotherapy for Patients With Brain Cancer", "OfficialTitle": "A Phase II Trial of Paclitaxel and Topotecan With Filgrastim in Patients With Recurrent or Refractory Glioblastoma Multiforme or Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1996-08", "PrimaryCompletionDate": "2001-04", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "paclitaxel", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "topotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02664363", "BriefTitle": "EGFRvIII CAR T Cells for Newly-Diagnosed WHO Grade IV Malignant Glioma", "OfficialTitle": "EGFRvIII Chimeric Antigen Receptor (CAR) Gene-modified T Cells for Patients With Newly-Diagnosed GBM During Lymphopenia", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2017-02-01", "PrimaryCompletionDate": "2018-09-25", "Interventions": [ { "Name": "EGFRvIII CAR T cells", "Type": "BIOLOGICAL", "Description": "The name of the drug is CAR gene-modified T cells or abbreviated as EGFRvIII CARs. The class of action is a biological and the mechanism of action is cytotoxicity. The drug substance is autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII. EGFRvIII CARs are genetically engineered T cells that have been taken from patients with GBM ex vivo to express a CAR recognizing the GBM tumor-specific antigen EGFRvIII, which is expressed on a subset of GBMs but not in normal human tissues with the aim of mediating regression of their tumors. Patients' CARs will be radiolabeled with 111In for correlative studies in the expanded cohort.", "OtherNames": [ "EGFRvIII CARs", "CAR-specific T cells", "CAR T cells", "CARs", "111Indium Labeled EGFRvIII CARs", "111In-Labeled EGFRvIII CARs", "CAR gene-modified T cells", "111In-labeled CARs" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Daniel Landi", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00667394", "BriefTitle": "Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors", "OfficialTitle": "A Phase 2 Trial of Tandutinib in Combination With Bevacizumab for Patients With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-04", "PrimaryCompletionDate": "2011-07", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab 10 mg/kg dose intravenous repeated once every 2 weeks.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "MLN-518 (Tandutinib)", "Type": "DRUG", "Description": "Tandutinib 500 mg by mouth daily dose twice a day.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "Quality-of-life assessment", "Type": "PROCEDURE", "Description": "Forty-five one-sentence questionnaire to assess health related quality of life in patients with brain cancer.", "OtherNames": [ "HRQL (health related quality of life)" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT00870181", "BriefTitle": "ADV-TK Improves Outcome of Recurrent High-Grade Glioma", "OfficialTitle": "Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-01", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "ADV-TK/GCV", "Type": "BIOLOGICAL", "Description": "gene therapy", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "systemic chemotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Huazhong University of Science and Technology", "LeadSponsorClass": "OTHER", "Collaborators": [ "Beijing Tiantan Hospital", "Beijing Chao Yang Hospital", "Beijing Friendship Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00250887", "BriefTitle": "Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research", "OfficialTitle": "A Phase II Open Label Study of the Pre- and Postoperative Use of ZD1839 (Iressa) in Recurrent Glioblastoma, Including Translational Research", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Gefitnib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03897491", "BriefTitle": "PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma", "OfficialTitle": "Evaluation of the Feasibility of PD L 506 for Stereotactic Interstitial Photodynamic Therapy (iPDT) in Adult Patients With Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-09-03", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "5-aminolevulinic acid", "Type": "DRUG", "Description": "5-aminolevulinic acid powder for oral solution", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "photonamic GmbH & Co. KG", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT07047066", "BriefTitle": "A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II Clinical Study to Evaluate the Efficacy and Safety of Flazoparib Combined With Temozolomide After the Completion of Standard Concurrent Chemoradiotherapy (CCRT) in Newly Diagnosed Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-07-10", "PrimaryCompletionDate": "2026-07-31", "Interventions": [ { "Name": "Fluzoparib with Temozolomide", "Type": "DRUG", "Description": "Fluzoparib: 100mg, po.bid. Q4W, d1-28, for a total of 6 cycles\n\nTemozolomide (TMZ): 150-200 mg/m2, po. Q4W, d1-5, for a total of 6 cycles\n\nIf unacceptable toxicity occurs and a dose reduction is required, it is recommended to first reduce the dose from 100 mg (2 tablets) to 50 mg (1 tablet) twice a day. If further dose reduction is required, it is recommended to reduce the dose from 50 mg (1 tablet) twice a day to 50 mg (1 tablet) once a day. If it is still intolerable, the patient should withdraw from the clinical study.\n\nThe TMZ dose is adjusted by the investigator according to standard chemotherapy requirements. Adjuvant TMZ treatment of less than 6 cycles is allowed depending on the subject's condition (e.g. confirmed disease progression, intolerable toxicity, etc.). Tumor assessment is performed during two cycles of TMZ (q8w±7 days) during the study or when clinically indicated", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Tongji Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02029573", "BriefTitle": "Efficacy and Safety of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma", "OfficialTitle": "Phase II Study of Atorvastatin in Combination With Radiotherapy and Temozolomide in Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-01-01", "PrimaryCompletionDate": "2016-12-31", "Interventions": [ { "Name": "Atorvastatin", "Type": "DRUG", "Description": "80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "60 Gy in 30 fractions", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "King Fahad Medical City", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02133183", "BriefTitle": "Sapanisertib Before and After Surgery in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Pilot Study of MLN0128 (TAK-228) in Preoperative Recurrent Glioblastoma (GBM) Patients", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2014-07-02", "PrimaryCompletionDate": "2020-01-31", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sapanisertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "INK-128", "INK128", "MLN-0128", "MLN0128", "TAK-228" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004262", "BriefTitle": "Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme", "OfficialTitle": "PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1999-11", "PrimaryCompletionDate": "2005-05", "Interventions": [ { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [ "surgery, conventional" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "3-dimensional conformal radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "3D conformal radiation therapy", "3D-CRT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "stereotactic radiosurgery", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "gadolinium texaphyrin", "Gd (III) Texaphryin", "Gd-Tex", "PCI-0120", "Xcytrin" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Undergo MRI with both the clinical 1.5 Tesla and research 8 Tesla magnets", "OtherNames": [ "MRI", "NMR imaging", "NMRI", "nuclear magnetic resonance imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "spectroscopy", "Type": "PROCEDURE", "Description": "Undergo plasma-atomic emission spectroscopy (DCP-AES)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04863950", "BriefTitle": "Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma", "OfficialTitle": "A Phase II, Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-05-25", "PrimaryCompletionDate": "2026-08", "Interventions": [ { "Name": "Lomustine", "Type": "DRUG", "Description": "For surgical cohort patients, lomustine will be initiated (C1D1) within 6 weeks of surgery as soon as patient is deemed by the investigator (or designee) to be recovered enough for chemotherapy. Initiation of lomustine must be initiated within 6 weeks. If patient cannot be safely initiated on lomustine within this timeframe then they will be replaced.\n\nFor non-surgical cohort patients (the decision for surgery is made independent of study participation), lomustine will be initiated on C1D1.\n\nFor both cohorts, lomustine will be administered as 110 mg/m2 PO once every 6 weeks.", "OtherNames": [ "Gleostine" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Imipramine Hydrochloride", "Type": "DRUG", "Description": "For the surgical cohort, imipramine hydrochloride will be initiated within a minimum of 16 days to a maximum of 3 weeks prior to surgery. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day to attain a maximum dose of 200mg/day in 16 days.\n\nFor non-surgical cohort patients (the decision for surgery is made independent of study participation), imipramine hydrochloride will be initiated on Cycle 1 Day 1. Imipramine hydrochloride will be administered as 50mg PO (oral) QHS (at bedtime) for 4 days followed by a dose increase (taper-up) of 50mg/day every fourth day, if tolerated, to attain a maximum dose of 200mg/day in 16 days.", "OtherNames": [ "Trofranil" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "The University of Texas Health Science Center at San Antonio", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00238797", "BriefTitle": "A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase II Exploratory, Multicentre, Open-label, Non-comparative Study of ZD1839 (Iressa™) and Radiotherapy in the Treatment of Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Gefitinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "AstraZeneca", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04772846", "BriefTitle": "Chloroquine for Glioblastoma.", "OfficialTitle": "Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-03-01", "PrimaryCompletionDate": "2020-12-01", "Interventions": [ { "Name": "Oral tablet", "Type": "DRUG", "Description": "Oral 250mg chloroquine tablets", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Oral placebo tablets", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Egyptian Medical Syndicate", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00643825", "BriefTitle": "Prolonged Adjuvant Temozolomide vs \"Stop & Go\" in Glioblastoma Patients", "OfficialTitle": "Randomized Multicentric Phase II Study of Prolonged Adjuvant Temozolomide or \"Stop and Go\" in Glioblastoma Patients: The PATSGO Study", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2008-01", "PrimaryCompletionDate": "2011-01", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Capsules 5,10,20,100,250 mg 200mg/m2/day , 5days per 28 till PD", "OtherNames": [ "TEMODAR, TEMODAL" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Observation till Progression then rechallenging with TMZ", "OtherNames": [ "TEMODAR, TEMODAL" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Cliniques universitaires Saint-Luc- Université Catholique de Louvain", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00504660", "BriefTitle": "6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients", "OfficialTitle": "Combination of 6-Thioguanine, Capecitabine, Celecoxib and Temozolomide or CCNU for Recurrent Anaplastic Glioma and Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-09", "PrimaryCompletionDate": "2010-08", "Interventions": [ { "Name": "Capecitabine", "Type": "DRUG", "Description": "Arms 1,3 = 825 mg/m\\^2 By Mouth (PO) Every 12 Hours on Day 14-27; Arms 2,3 = 825 mg/m\\^2 PO Every 12 Hours on Day 11-24.", "OtherNames": [ "Xeloda" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Celecoxib (Celebrex)", "Type": "DRUG", "Description": "Arms 1,3 = 400 mg PO Every 12 Hours On Day 14-27; Arms 2,3 = 400 mg PO Every 12 Hours On Day 11-24.", "OtherNames": [ "Celebrex" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Arms 1,3 = 150 mg/m\\^2 PO Daily On Day 4-8.", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Arms 2,3 = 100 mg/m\\^2 PO on Day 4.", "OtherNames": [ "CCNU" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "6-Thioguanine", "Type": "DRUG", "Description": "Arms 1,2,3 = 80 mg/m\\^2 PO Every 6 Hours on Day 1-3.", "OtherNames": [ "Thioguanine", "6-TG" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06814496", "BriefTitle": "Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors", "OfficialTitle": "RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-09-08", "PrimaryCompletionDate": "2030-05", "Interventions": [ { "Name": "Tarlatamab", "Type": "DRUG", "Description": "Tarlatamab will be administered at a step-up dose of 1mg on Cycle 1 Day 1 and then 10 mg on Cycle 1 Day 8 and Cycle 1 Day 15 and every 2 weeks thereafter. For cycle 2 onwards, tarlatamab infusion will occur every 2 weeks on days 1 and 15 of each cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Concurrent Radiation Therapy", "Type": "RADIATION", "Description": "Standard of care RT can begin as early as Cycle 1 Day 16 and as late as Cycle 2 Day 28, assuming there is no ongoing CRS (extracranial)/ICANS (cranial).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sequential Radiation therapy", "Type": "RADIATION", "Description": "Standard of care radiation therapy can occur prior to Cycle 1 Day 1 (if radiation treatment is completed \\<7 days prior to the start of tarlatamab) or be interdigitated with tarlatamab with a 7-day washout between RT and infusion, with RT to begin as early as Cycle 1 Day 22 and as late as cycle 2 Day 28, assuming no ongoing CRS (extracranial)/ICANS (cranial).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Arizona", "LeadSponsorClass": "OTHER", "Collaborators": [ "Amgen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04444427", "BriefTitle": "Evaluation of GLR2007 for Advanced Solid Tumors", "OfficialTitle": "An Open-Label, Multicenter, Phase 1b/2 Study to Establish Safety, Tolerability, and Optimal Dosing Strategy of GLR2007 in Subjects With Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-07-15", "PrimaryCompletionDate": "2022-07-29", "Interventions": [ { "Name": "GLR2007", "Type": "DRUG", "Description": "Administered orally, once daily for 21 days followed by a 7-day treatment holiday.", "OtherNames": [ "GLR2007-237FA" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Gan and Lee Pharmaceuticals, USA", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03276286", "BriefTitle": "Nativis Voyager for Newly Diagnosed GBM", "OfficialTitle": "A Feasibility Study of the Nativis Voyager® System in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-11-10", "PrimaryCompletionDate": "2022-05-31", "Interventions": [ { "Name": "Nativis Voyager", "Type": "DEVICE", "Description": "Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Nativis, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04614909", "BriefTitle": "Study of Pamiparib in Newly Diagnosed and rGBM", "OfficialTitle": "A Phase 0/2 Clinical Trial of Pamiparib in Newly-Diagnosed and Recurrent Glioblastoma Patients", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-01-11", "PrimaryCompletionDate": "2024-07-26", "Interventions": [ { "Name": "Pamiparib", "Type": "DRUG", "Description": "60mg administered orally BID for 4 days prior to surgical resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Olaparib", "Type": "DRUG", "Description": "200mg administered orally BID for 4 days prior to surgical resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Arm A and Arm B participants after RT is completed, will receive pamiparib in combination with TMZ (newly diagnosed participants). Arm C participants will receive olaparib with TMZ.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Institute", "Ivy Brain Tumor Center", "BeiGene" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT05304663", "BriefTitle": "Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression", "OfficialTitle": "A Study to Evaluate the Safety and Efficacy of Different Administration Sequences of L19TNF in Combination With Lomustine in Patients With Glioblastoma at First Progression", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2022-06-01", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "Onfekafusp alfa", "Type": "DRUG", "Description": "Patients will be treated with 10 µg/kg L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26", "OtherNames": [ "L19TNF" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Arm 1: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (60 mg/m2 and 75 mg/m2) on Day 1 and Day 22 (taken in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles.\n\nArm 2: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (90 mg/m2 and 110 mg/m2) on Day 5 (in the evening after infusion of L19TNF) of a 42-day cycle for up to a maximum of 6 cycles.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Philogen S.p.A.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02287428", "BriefTitle": "Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM", "OfficialTitle": "A Phase I Study of a Personalized NeoAntigen Cancer Vaccine With Radiotherapy Plus Pembrolizumab/MK-3475 Among Newly Diagnosed Glioblastoma Patients", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2014-11", "PrimaryCompletionDate": "2026-02", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Standard radiotherapy (approximately 60 Gy over 6 weeks)", "OtherNames": [ "RT, XRT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Personalized NeoAntigen Peptides", "Type": "BIOLOGICAL", "Description": "NeoVax Vaccine (Personalized NeoAntigen Peptides + Poly-ICLC) will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab will be administered every 3 weeks at a flat dose of 200 mg intravenously. Pembrolizumab should be administered as a 30 minute IV infusion (Pembrolizumab treatment cycle intervals may be increased due to toxicity per protocol).", "OtherNames": [ "MK-3475, Keytruda" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concurrent Temozolomide (TMZ) = 75 mg/m2/day for 6 weeks, administered with XRT", "OtherNames": [ "Concurrent temozolomide; Concurrent TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Adjuvant Temozolomide (TMZ) = 150 mg/m2/day on days 1-5 of each 28-day cycle for up to 6 adjuvant cycles", "OtherNames": [ "Adjuvant temozolomide; Adjuvant TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Poly-ICLC", "Type": "BIOLOGICAL", "Description": "NeoVax Vaccine (Personalized NeoAntigen Peptides + Poly-ICLC) will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases.", "OtherNames": [ "Hiltonol" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "The Ben & Catherine Ivy Foundation", "Accelerate Brain Cancer Cure", "Merck Sharp & Dohme LLC", "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02898012", "BriefTitle": "Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status", "OfficialTitle": "Temozolomide Plus Bevacizumab Chemotherapy in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status (KPS<70)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2013-05", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) Temozolomide (TMZ) administered at 130-150 mg/m2 for 5 consecutive days every 4 weeks up to 12 cycles. IV or oral administration was allowed according to the clinical status. TMZ starts at 130 mgs/m2 and increase to 150 mgs/m2 during the second cycle in the absence of hematologic toxicity. In the case of grade 3 or 4 toxicity, the dose for the next cycle is decreased to 110 mg/m2. If the grade 3 or 4 toxicity persists at a dose of 110 mg/m2, treatment is discontinued.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab (Bev) administered at a dose of 10 mgs/kg every 2 weeks. Bev was interrupted in cases of wound healing disturbances, gastrointestinal perforation, intestinal occlusion, fistula, uncontrolled hypertension, nephrotic syndrome, grade 4 or recurrent grade 3 thromboembolic events, arterial thrombosis, hemorrhage \\> grade 2, left ventricular failure, or posterior reversible leukoencephalopathy.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [ "Roche Pharma AG" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00770471", "BriefTitle": "ABT-888, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Trial of Temozolomide and ABT-888 in Subjects With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-07-13", "PrimaryCompletionDate": "2012-03-01", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "veliparib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "DNA methylation analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "Name": "gene expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "mutation analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "proteomic profiling", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "high performance liquid chromatography", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "immunoenzyme technique", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "mass spectrometry", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacogenomic studies", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "NCTId": "NCT01777919", "BriefTitle": "Disulfiram/Copper Combination In The Treatment of Newly Diagnosed Glioblastoma Multiform", "OfficialTitle": "A PHASE II CLINICAL TRIAL FOR THE EVALUATION OF THE EFFICACY OF DISULFIRAM/COPPER COMBINATION AS AN ADJUVANT AND CONCURRENT CHEMOTHERAPY IN THE TREATMENT OF NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORM", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2027-01", "PrimaryCompletionDate": "2029-01", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "already included", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Disulfiram", "Type": "DRUG", "Description": "already included", "OtherNames": [ "Antabuse" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Copper", "Type": "DRUG", "Description": "already included", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Olympion Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Ioannina", "University of Eastern Finland", "University of Ulm" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03861299", "BriefTitle": "The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.", "OfficialTitle": "The SAFE-Trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy Versus Surgery Under General Anesthesia. A Multicenter Prospective Randomised Controlled Study", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2019-04-01", "PrimaryCompletionDate": "2026-09-01", "Interventions": [ { "Name": "Awake craniotomy", "Type": "PROCEDURE", "Description": "Awake craniotomy", "OtherNames": [ "Intraoperative stimulation monitoring with (sub)cortical electrostimulation", "Intraoperative brain mapping with (sub)cortical electrostimulation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Craniotomy under general anesthesia", "Type": "PROCEDURE", "Description": "Craniotomy under general anesthesia", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jasper Gerritsen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Elisabeth-TweeSteden Ziekenhuis", "University Medical Center Groningen", "Medical Center Haaglanden", "University Hospital, Ghent" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05765812", "BriefTitle": "A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-05-15", "PrimaryCompletionDate": "2028-09", "Interventions": [ { "Name": "Debio 0123", "Type": "DRUG", "Description": "Administered as capsules.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Administered as capsules.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Administered in accordance with the local clinical practice and applicable Radiation Therapy Oncology Group (RTOG) or the European Organization for Research and Treatment of Cancer (EORTC) guidelines.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Debiopharm International SA", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01220271", "BriefTitle": "A Study Combining LY2157299 With Temozolomide-based Radiochemotherapy in Patients With Newly Diagnosed Malignant Glioma", "OfficialTitle": "Phase 1b/2a Study Combining LY2157299 With Standard Temozolomide-based Radiochemotherapy in Patients With Newly Diagnosed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-04", "PrimaryCompletionDate": "2015-08", "Interventions": [ { "Name": "LY2157299", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "DRUG", "Description": "Administered as approved", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01474239", "BriefTitle": "A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma", "OfficialTitle": "Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-11", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "bevacizumab [Avastin]", "Type": "DRUG", "Description": "10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "fotemustine", "Type": "DRUG", "Description": "75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00731731", "BriefTitle": "Vorinostat, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]), Temozolomide, and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-07-10", "PrimaryCompletionDate": "2014-02-02", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiotherapy", "OtherNames": [ "3-dimensional radiation therapy", "3D Conformal", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy", "Radiation, 3D Conformal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Cognitive Assessment", "Type": "PROCEDURE", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Vorinostat", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "L-001079038", "MSK-390", "SAHA", "Suberanilohydroxamic Acid", "Suberoylanilide Hydroxamic Acid", "Zolinza" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00482677", "BriefTitle": "Radiation Therapy With or Without Temozolomide in Treating Older Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Randomized Phase III Study of Temozolomide and Short-Course Radiation Versus Short-Course Radiation Alone In The Treatment of Newly Diagnosed Glioblastoma Multiforme in Elderly Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2007-11-14", "PrimaryCompletionDate": "2016-03-01", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "Temozolomide (concurrent with radiation) 75 mg/m2 PO 3 weeks once a day, daily, from the first day to the last day of radiotherapy, but for no longer than 28 days, and then adjuvantly for up to 12 cycles (150 mg/m2 for the first 5 days of each cycle). Adjuvant TMZ may be escalated to 200mg/m2 in C2 onward if appropriate.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "DNA methylation analysis", "Type": "GENETIC", "Description": "A stratified log-rank test, adjusting for the stratification factors (except centre) plus MGMT promoter methylation status, will be used as the primary method to compare the overall survival between the two arms", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "Name": "quality-of-life assessment", "Type": "PROCEDURE", "Description": "prior to randomization until end of study", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Short course radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Canadian Cancer Trials Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "European Organisation for Research and Treatment of Cancer - EORTC", "Trans Tasman Radiation Oncology Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "NCTId": "NCT06504381", "BriefTitle": "DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma", "OfficialTitle": "A Phase I/IIa Study to Evaluate the Efficacy of DB107-RRV (Formerly Toca511), Administered to Subjects at Time of Resection and Intravenously Thereafter, in Combination With DB107-FC (Formerly Toca FC) and Radiation Therapy or DB107-FC, Temozolomide (TMZ) and Radiation Therapy in Patients With Newly Diagnosed High Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-01-08", "PrimaryCompletionDate": "2028-01-31", "Interventions": [ { "Name": "DB107-RRV", "Type": "GENETIC", "Description": "Given intracranially (IC) during resection and intravenously (IV) immediately following", "OtherNames": [ "Toca 511", "Vocimagene amiretrorepvec" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "DB107-FC", "Type": "DRUG", "Description": "Given orally (PO)", "OtherNames": [ "Toca FC", "Extended-release 5-fluorocytosine", "5-fluorocytosine" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy (RT)", "Type": "RADIATION", "Description": "Undergo RT", "OtherNames": [ "Radiation Treatment" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Temozolomide (TMZ)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Magnetic Resonance Imaging (MRI)", "Type": "PROCEDURE", "Description": "Undergo standard of care MRI", "OtherNames": [ "MR", "MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgical resection", "Type": "PROCEDURE", "Description": "Undergo non-investigational tumor resection", "OtherNames": [ "Surgical tumor resection", "Brain surgery" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "California Institute for Regenerative Medicine (CIRM)", "Denovo Biopharma LLC", "Anova Enterprises, Inc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00337207", "BriefTitle": "Bevacizumab in Treating Patients With Recurrent or Progressive Glioma", "OfficialTitle": "A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-03", "PrimaryCompletionDate": "2008-11", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab 15 mg/kg every 3 weeks over 30 to 90 minutes. One cycle = 3 weeks. Treatment continues until progressive disease or unacceptable toxicity.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01985256", "BriefTitle": "Study of a Retroviral Replicating Vector Given Intravenously to Patients Undergoing Surgery for Recurrent Brain Tumor", "OfficialTitle": "A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for Recurrent HGG & Followed by Treatment With Extended-Release 5-FC", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2016-03-03", "Interventions": [ { "Name": "Toca 511", "Type": "BIOLOGICAL", "Description": "All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene, intravenously and then intracranially. CD converts the antifungal 5-fluorocytosine (5-FC) to the anti-cancer drug 5-fluorouracil (5-FU) in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after the second administration of Toca 511,patients will begin 7-day course of oral 5-FC, repeated every 4 weeks for the duration of the study.", "OtherNames": [ "vocimagene amiretrorepvec", "retroviral replicating vector (RRV)" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC", "Type": "DRUG", "Description": null, "OtherNames": [ "flucytosine, 5-FC, 5-FC XR, Toca FC" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00014300", "BriefTitle": "Glufosfamide in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-01", "PrimaryCompletionDate": "2001-09", "Interventions": [ { "Name": "glufosfamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02715609", "BriefTitle": "Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I/II Dose-escalation and Dose-expansion Study of Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-06-15", "PrimaryCompletionDate": "2024-05-12", "Interventions": [ { "Name": "Disulfiram", "Type": "DRUG", "Description": null, "OtherNames": [ "DSF", "Antabuse®" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Copper Gluconate", "Type": "DRUG", "Description": null, "OtherNames": [ "Copper", "Cu" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar®" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07119294", "BriefTitle": "Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.", "OfficialTitle": "Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-08", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "FAPI PET/MR", "Type": "DIAGNOSTIC_TEST", "Description": "FAPI PET/MR prior surgery or during recurrence suspiscion", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jules Bordet Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05139277", "BriefTitle": "Evaluation of the CONVIVO System", "OfficialTitle": "Clinical Investigation to Evaluate the CONVIVO System for Discrimination of Normal From Abnormal Tissue During Brain Tumor Resection", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-06-28", "PrimaryCompletionDate": "2025-06", "Interventions": [ { "Name": "CONVIVO system", "Type": "DIAGNOSTIC_TEST", "Description": "Approximately 2-5 minutes following administration of FNa in situ imaging will be performed by the participating surgeon ensuring proper technique. Prior to entering the surgical field, the probe will be covered in a disposable sterile sheath that is manufactured with quality assurance for this purpose. The probe will gently be held against the tissue interface while imaging occurs. Again this will only be in regions that would normally be resected or sampled in routine clinical care. Following image acquisition, a neuropathologist present in the operating room, will review and capture each image.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Conventional histologic evaluation", "Type": "OTHER", "Description": "Following image acquisition, the tissue region imaged with the CONVIVO system will then be biopsied using biopsy forceps. This will be passed immediately off the surgical field as a research specimen and provided to a member of the research team to be prepared for conventional histologic evaluation. The specimen will be labeled with the deidentified subject and sample number. This sequence will then be repeated for each successive sample.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Carl Zeiss Meditec, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01806675", "BriefTitle": "18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy", "OfficialTitle": "Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-03-04", "PrimaryCompletionDate": "2016-12-07", "Interventions": [ { "Name": "18F-fludeoxyglucose (18F-FDG)", "Type": "DRUG", "Description": "18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan", "OtherNames": [ "Fludeoxyglucose F-18", "18-FDG", "FDG" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "18F-FPPRGD2", "Type": "DRUG", "Description": "18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.", "OtherNames": [ "(18F)-2-fluoropropionyl-labeled PEGylated dimeric arginine-glycine-aspartic acid peptide", "[PEG3-E{c(RGDyk)}2]", "fluorine-18-FPPRGD2", "[18F]-FPPRGD2", "2-fluoropropionyl-labeled pegylated dimeric RGD peptide", "104150" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sanjiv Sam Gambhir", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00028795", "BriefTitle": "Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma", "OfficialTitle": "A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-12", "PrimaryCompletionDate": "2007-09", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00019019", "BriefTitle": "Carboxyamidotriazole and Paclitaxel in Treating Patients With Advanced Solid Tumors or Refractory Lymphomas", "OfficialTitle": "A PHASE I STUDY OF THE COMBINATION OF CAI AND PACLITAXEL IN ADULT PATIENTS WITH REFRACTORY CANCERS OR LYMPHOMA", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1994-10", "PrimaryCompletionDate": "2006-07", "Interventions": [ { "Name": "carboxyamidotriazole", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "paclitaxel", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Institutes of Health Clinical Center (CC)", "LeadSponsorClass": "NIH", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05902169", "BriefTitle": "Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM", "OfficialTitle": "A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma.", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-01-29", "PrimaryCompletionDate": "2028-01-28", "Interventions": [ { "Name": "SonoCloud-9 (SC9)", "Type": "DEVICE", "Description": "Implantation of SC9 device and repeat activation at constant acoustic pressure", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Dose of carboplatin AUC 5 mg/ml.min-1 calculated using Calvert's formula:\n\nDose (mg) = target AUC (mg/mL x minute) x \\[glomerular filtration rate (GFR) mL/minute + 25\\].", "OtherNames": [ "CycloButane DiCarboxylic Acid (CBDCA)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Dosed and administered per labelling.", "OtherNames": [ "1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (CCNU)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Dosed and administered per labelling.", "OtherNames": [ "Temodal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CarThera", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02197169", "BriefTitle": "DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors", "OfficialTitle": "A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-09-11", "PrimaryCompletionDate": "2018-03-15", "Interventions": [ { "Name": "Single intratumoral injection of DNX-2401", "Type": "DRUG", "Description": "In the randomized group, following brain tumor biopsy and histological confirmation of recurrent glioblastoma/gliosarcoma, a single injection of DNX-2401 was administered directly into the brain tumor with or without subsequent interferon gamma (IFN-γ)\n\nNo additional subjects will be randomized. A single intratumoral dose of DNX-2401 will be delivered by cannula.", "OtherNames": [ "Oncolytic virus", "Genetically-modified adenovirus" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Interferon-gamma", "Type": "DRUG", "Description": "In the randomized group, a single injection of DNX-2401 was followed by interferon gamma (IFN-γ). No additional subjects will be randomized or receive IFN-γ following DNX-2401", "OtherNames": [ "Actimmune", "immunotherapy", "gamma interferon" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "DNAtrix, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04963413", "BriefTitle": "RENEW: Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.", "OfficialTitle": "RENEW: Pilot Study of Feasibility of CMV RNA-Pulsed Dendritic Cells Vaccines for the Treatment of Newly Diagnosed Glioblastoma Patients.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2022-01-13", "PrimaryCompletionDate": "2023-09-28", "Interventions": [ { "Name": "Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF", "Type": "BIOLOGICAL", "Description": "Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Immunomic Therapeutics, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00995007", "BriefTitle": "A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas", "OfficialTitle": "A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2015-06", "Interventions": [ { "Name": "ZD6474 (Vandetanib)", "Type": "DRUG", "Description": "Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05376800", "BriefTitle": "A Study to Determine How BI 907828 (Brigimadlin) is Taken up in the Tumor (Phase 0) and to Determine the Highest Dose of BI 907828 (Brigimadlin) That Could be Tolerated (Phase 1a) in Combination With Radiation Therapy in People With a Brain Tumor Called Glioblastoma", "OfficialTitle": "A Phase 0/Ia Study of BI 907828 (Brigimadlin) Concentrations in Brain Tissue and a Non-randomized Open-label, Dose Escalation Study of BI 907828 (Brigimadlin) in Combination With Radiotherapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-11-30", "PrimaryCompletionDate": "2025-07-31", "Interventions": [ { "Name": "BI 907828 (Brigimadlin)", "Type": "DRUG", "Description": "BI 907828 (Brigimadlin)", "OtherNames": [ "Brigimadlin" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boehringer Ingelheim", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06598787", "BriefTitle": "A Study of BL-B01D1 in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-10-17", "PrimaryCompletionDate": "2026-10", "Interventions": [ { "Name": "BL-B01D1 for Injection", "Type": "DRUG", "Description": "Administration by intravenous infusion for a cycle of 3 weeks.", "OtherNames": [ "iza-bren", "izalontamab brengitecan", "BMS-986507" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sichuan Baili Pharmaceutical Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Baili-Bio (Chengdu) Pharmaceutical Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01280552", "BriefTitle": "A Study of ICT-107 Immunotherapy in Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Randomized, Double-blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT-107 in Newly Diagnosed Patients With Glioblastoma Multiforme (GBM) Following Resection and Chemoradiation", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-01", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "ICT-107", "Type": "BIOLOGICAL", "Description": "Autologous dendritic cells pulsed with immunogenic antigens", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo DC", "Type": "BIOLOGICAL", "Description": "Autologous dendritic cells (DC) that have not been pulsed with antigens", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Precision Life Sciences Group", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05802693", "BriefTitle": "A Study to Evaluate the Safety, Tolerance and Initial Efficacy of EGFRvIII CAR-T on Glioblastoma", "OfficialTitle": "An Open Clinical Study to Evaluate the Safety, Tolerance and Initial Efficacy of Epidermal Growth Factor Receptor Variant III Chimeric Antigen Receptor T(EGFRvIII CAR-T) in the Treatment of Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-11-15", "PrimaryCompletionDate": "2025-11-14", "Interventions": [ { "Name": "Targeted Epidermal Growth Factor Receptor Variant III(EGFRvIII) autochimeric antigen receptor T cell injection", "Type": "DRUG", "Description": "Infusion of Epidermal Growth Factor Receptor Variant III Chimeric antigen receptor T(EGFRvIII CAR-T) with Omaya capsule", "OtherNames": [ "DCTY0801 Autologous T lymphocyte injection" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Beijing Tsinghua Chang Gung Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Beijing DCTY Biotech Co.,Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT04047264", "BriefTitle": "Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies", "OfficialTitle": "Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-01-01", "PrimaryCompletionDate": "2027-09-01", "Interventions": [ { "Name": "Microdialysis", "Type": "PROCEDURE", "Description": "Undergo microdialysis", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance Imaging (MRI)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "NMR Imaging", "Nuclear Magnetic Resonance Imaging (NMRI)", "nuclear magnetic resonance imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "National Institute of Neurological Disorders and Stroke (NINDS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003567", "BriefTitle": "Gene Therapy and Chemotherapy in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma", "OfficialTitle": "Mutant MGMT Gene Transfer Into Human Hematopoietic Progenitors to Protect Hematopoiesis During O6-Benzylguanine (BG, NSC 637037) and Carmustine Followed by Temozolomide Therapy of Advanced Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "1999-05", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": "Patients receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-5 (or G-CSF twice daily alone for 4-5 days).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "therapeutic autologous lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": "Patients receive O6-benzylguanine (BG) IV over 1 hour every 6 weeks for 5 courses. Four weeks after the completion of BG and carmustine, patients receive BG IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": "Patients receive carmustine IV over 1 hour every 6 weeks for 5 courses.Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Four weeks after the completion of BG and carmustine, patients receive temozolomide IV over 1 hour every 4 weeks for up to 5 courses, in the absence of hematologic toxicity. Patients with responding disease may continue to receive BG and temzolomide in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "in vitro-treated peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": "Approximately 72 hours after the end of the first course of chemotherapy, patients receive reinfusion of retrovirally-transduced hematopoietic stem cells over 5-10 minutes. Cohorts of 3-6 patients receive escalating numbers of CD34 stem cells targeted for retroviral infection and escalating doses of carmustine.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00010036", "BriefTitle": "Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-05", "PrimaryCompletionDate": "2001-10", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00820963", "BriefTitle": "Standard Radiation Therapy, Higher-Dose Radiation Therapy, or Chemotherapy in Treating Older Patients With Glioblastoma Multiforme", "OfficialTitle": "Randomized Study of Normal-fractionated Radiotherapy Versus Hypofractionated Radiotherapy Versus Chemotherapy in Patients Over 60 Years With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2006-07", "PrimaryCompletionDate": "2011-05", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "hypofractionated radiation therapy", "Type": "RADIATION", "Description": "Patients undergo hypofractionated radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Patients undergo standard radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Leon Berard", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05977738", "BriefTitle": "Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin", "OfficialTitle": "Phase 0 lead-in Trial of Pitavastatin in Primary and Recurrent Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2024-01-18", "PrimaryCompletionDate": "2024-07-19", "Interventions": [ { "Name": "Pitavastatin calcium", "Type": "DRUG", "Description": "Daily Pitavastatin administration", "OtherNames": [ "Alipza" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "C.Dirven", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04396860", "BriefTitle": "Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma", "OfficialTitle": "A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab Versus Temozolomide in Patients With Newly Diagnosed MGMT (Tumor O-6-Methylguanine DNA Methyltransferase) Unmethylated Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2020-09-01", "PrimaryCompletionDate": "2023-01-13", "Interventions": [ { "Name": "Contrast-enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo contrast-enhanced brain MRI", "OtherNames": [ "CONTRAST ENHANCED MRI", "Contrast-enhanced MRI", "MRI With Contrast" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Ipilimumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody", "BMS 734016", "BMS-734016", "BMS734016", "Ipilimumab Biosimilar CS1002", "MDX 010", "MDX-010", "MDX-CTLA4", "MDX010", "Yervoy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 206", "BCD-263", "BMS 936558", "BMS-936558", "BMS936558", "CMAB819", "MDX 1106", "MDX-1106", "MDX1106", "NIVO", "Nivolumab Biosimilar ABP 206", "Nivolumab Biosimilar BCD-263", "Nivolumab Biosimilar CMAB819", "ONO 4538", "ONO-4538", "ONO4538", "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "NovoTTF-100A Device", "Type": "DEVICE", "Description": "Wear Optune device", "OtherNames": [ "NovoTTF-100A", "NovoTTF-100A System", "NovoTTF-100A system (Optune)", "NovoTTFields", "NovoTumor Treatment Fields", "Optune", "Optune Device" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00498979", "BriefTitle": "Sodium Stibogluconate and IFNa-2b Followed By CDDP, VLB and DTIC Treating Pts.With Advanced Melanoma or Other Cancers", "OfficialTitle": "Phase I Evaluation of Sodium Stibogluconate in Combination With Interferon α-2b Followed by Cisplatin, Vinblastine and Dacarbazine for Patients With Melanoma or Malignancies Potentially Responsive to SSG and/or Interferons", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-05", "PrimaryCompletionDate": "2010-05", "Interventions": [ { "Name": "recombinant interferon alfa-2b", "Type": "BIOLOGICAL", "Description": "recombinant interferon alfa-2b", "OtherNames": [ "IFN 2b" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": "recombinant interferon alfa-2b", "OtherNames": [ "CDDP" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sodium stibogluconate", "Type": "DRUG", "Description": "sodium stibogluconate", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "dacarbazine", "Type": "DRUG", "Description": "dacarbazine", "OtherNames": [ "DTIC" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "vinblastine", "Type": "DRUG", "Description": "vinblastine", "OtherNames": [ "VBL" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04314674", "BriefTitle": "Comparison of Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumors Resection", "OfficialTitle": "Comparison of Continuous Infusion of 3% Hypertonic Saline, Bolus of 3% Hypertonic Saline and Mannitol on Brain Relaxation During Supratentorial Tumor Resection: A Prospective, Randomized, Clinical Study", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2020-04", "PrimaryCompletionDate": "2022-04", "Interventions": [ { "Name": "%3 HS bolus", "Type": "DRUG", "Description": "After head fixation %3 HS bolus 3 ml/kg will be administered", "OtherNames": [ "Group 1" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "%3 HS infusion 20 ml/h", "Type": "DRUG", "Description": "After head fixation %3 HS 20 ml/h infusion will be administered", "OtherNames": [ "Group 2" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "20% mannitol", "Type": "DRUG", "Description": "After head fixation %20 mannitol 0.6 ml/kg will be administered", "OtherNames": [ "Group 3" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Istanbul University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00390403", "BriefTitle": "Gossypol (AT-101) and Temozolomide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I, Open Label Study of AT-101 Plus Radiotherapy and Temozolomide and of AT-101 Plus Adjuvant Temozolomide for Patients With Newly-Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-02", "PrimaryCompletionDate": "2009-06", "Interventions": [ { "Name": "R-(-)-gossypol acetic acid", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "gene expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "mutation analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "protein expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01122888", "BriefTitle": "Cilengitide and Sunitinib Malate in Treating Patients With Advanced Solid Tumors or Glioblastoma Multiforme", "OfficialTitle": "Pilot Biomarker Study of the Integrin AlphavBeta3 Antagonist Cilengitide (EMD121974) in Combination With Sunitinib", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2009-12", "PrimaryCompletionDate": "2012-09", "Interventions": [ { "Name": "Cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974", "EMD-121974" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Clinical Observation", "Type": "OTHER", "Description": "Patients undergo a 2-week rest period", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT06113705", "BriefTitle": "Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study.", "OfficialTitle": "Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study.", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-11-01", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "18F-GE-180 PET", "Type": "DIAGNOSTIC_TEST", "Description": "PET examination of glioblastoma using 18F-GE-180 PET radio-metabolic marker", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Advanced MRI", "Type": "DIAGNOSTIC_TEST", "Description": "MRI examination using advanced sequences to characterize tumor microstructure and function", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Collection of hematopoietic stem cells", "Type": "OTHER", "Description": "Hematopoietic stem cells will be collected by the aspiration of bone marrow during the surgical intervention for tumor resection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Blood withdrawal", "Type": "OTHER", "Description": "blood withdrawal for evaluation of plasma biomarkers of inflammation, circulating microvesicles, and RNA", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Collection of Cancer Stem Cells", "Type": "OTHER", "Description": "Glioblastoma stem cells (GSCs) will be isolated from the tumor", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Istituto Clinico Humanitas", "LeadSponsorClass": "OTHER", "Collaborators": [ "Mediolanum Cardio Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01112527", "BriefTitle": "PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma", "OfficialTitle": "An Open-Label, Phase 2 Trial of Orally Administered PF-00299804 in Adult Patients With Relapsed/Recurrent Glioblastoma (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2015-09", "Interventions": [ { "Name": "PF-00299804", "Type": "DRUG", "Description": "Taken orally once a day", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dana-Farber Cancer Institute", "Brigham and Women's Hospital", "Henry Ford Hospital", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06011109", "BriefTitle": "Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab", "OfficialTitle": "A Pilot Study of APG-157 With Bevacizumab for Patients With Recurrent High-Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-12-13", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "APG-157", "Type": "DRUG", "Description": "The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Aveta Biomics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00095771", "BriefTitle": "Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas", "OfficialTitle": "A Phase I Trial of Arsenic Trioxide in the Treatment of Infiltrating Gliomas of Childhood", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-11", "PrimaryCompletionDate": "2011-01", "Interventions": [ { "Name": "arsenic trioxide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01931098", "BriefTitle": "Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab", "OfficialTitle": "A Phase II Trial of Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A)Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-12-10", "PrimaryCompletionDate": "2019-09-12", "Interventions": [ { "Name": "topotecan", "Type": "DRUG", "Description": "Taken .25 mg orally, daily continuous until progression up to one year.", "OtherNames": [ "Hycamtin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "pazopanib", "Type": "DRUG", "Description": "600 mg orally, daily until progression, up to one year.", "OtherNames": [ "Votrient" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00003458", "BriefTitle": "Antineoplaston Therapy in Treating Children With Brain Tumors", "OfficialTitle": "Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1996-09", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03278249", "BriefTitle": "Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma", "OfficialTitle": "Feasibility Study of Modified Atkins Ketogenic Diet in the Treatment of Newly Diagnosed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-10-12", "PrimaryCompletionDate": "2021-12-01", "Interventions": [ { "Name": "Modified Atkins Ketogenic Diet", "Type": "OTHER", "Description": "Less than 20 grams of carbohydrates per day", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "University of Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00984438", "BriefTitle": "Surgery With Implantable Biodegradable Carmustine (BCNU) Wafer Followed by Chemo for Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Trial for Patients With Recurrent Resectable Glioblastoma Multiforme Using Surgery With Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2010-06", "Interventions": [ { "Name": "BCNU Wafer", "Type": "DRUG", "Description": "Implantable during surgical resection into the tumor bed", "OtherNames": [ "Gliadel Wafer" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "IV every 2 weeks for up to one year", "OtherNames": [ "CPT-11" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "IV every 2 weeks for up to one year", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "Eisai Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00093964", "BriefTitle": "Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor)", "OfficialTitle": "A Multicenter, Open-label, Randomized, Uncontrolled, Phase IIa Trial in Subjects With Recurrent Glioblastoma Multiforme to Investigate the Clinical Activity, Safety, and Tolerability of Cilengitide (EMD 121,974) Administered as a Single Agent.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-10-13", "PrimaryCompletionDate": "2005-10-28", "Interventions": [ { "Name": "Cilengitide 500 mg", "Type": "DRUG", "Description": "Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.", "OtherNames": [ "EMD 121974" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cilengitide 2000 mg", "Type": "DRUG", "Description": "Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.", "OtherNames": [ "EMD 121974" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "EMD Serono", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05664464", "BriefTitle": "Glutamate Inhibitors in Glioblastoma", "OfficialTitle": "A Phase Ib/II Randomized, Open Label Drug Repurposing Trial of Glutamate Signaling Inhibitors in Combination With Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-01-01", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "Gabapentin", "Type": "DRUG", "Description": "Weekly dose escalations over 4 weeks of daily 3 x 300 mg up to 3 x 1200 mg", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sulfasalazine", "Type": "DRUG", "Description": "Weekly dose escalations over 3 weeks of daily 3 x 500 mg up to 3 x 1500 mg", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Memantine", "Type": "DRUG", "Description": "Weekly dose escalations over 4 weeks of daily 1 x 5-20 mg", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concomitant with radiotherapy at 75 mg/m2 daily followed by maintenance 150-200 mg/m2 on 5/28 days", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "30 x 2 Gy involved field radiotherapy with concomitant temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [ "Swiss National Science Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03224104", "BriefTitle": "Multi-kinase Inhibitor TG02 (TG02) in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma.", "OfficialTitle": "Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma: A Phase Ib Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-06-12", "PrimaryCompletionDate": "2022-05-05", "Interventions": [ { "Name": "TG02", "Type": "DRUG", "Description": "The initial cohorts of Groups A and B will receive TG02 at 200 mg on intermittent schedules in combination with either RT or TMZ. TG02 will be escalated to 250 mg if the dose decision criteria are met in the first cohort.\n\nThe initial cohort in Group C will receive TG02 alone at 250 mg on intermittent schedules. It will be continued at this dose if feasible or decreased to 200 or 150 mg if not tolerated.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "For group A standard involved-field hypofractionated RT will be administered at 39.9 Gy in 15 fractions of 2.66 Gy for 3 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "For group B TMZ will be given in the standard 28-day cycle regimen (150-200 mg/m2) for 5 days.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Tragara Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01450449", "BriefTitle": "Short Course vs. Standard Course Radiotherapy in Elderly and/or Frail Patients With Glioblastoma Multiforme", "OfficialTitle": "A Randomized Phase III Study of Short Course (One-week) Radiation Therapy Versus Standard Course (Three-week) Radiation Therapy in Elderly and/or Frail Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2009-02", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "25 Gy in 5 daily fractions over 1 week", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "40 Gy in 15 daily fractions over 3 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "International Atomic Energy Agency", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "Fundación Escuela de Medicina Nuclear", "N.N. Alexandrov National Cancer Centre", "Hospital A.C. Camargo", "Irmandade Santa Casa de Misericórdia de Porto Alegre", "Instituto de Radiomedicina (IRAM)", "Post Graduate Institute of Medical Education and Research, Chandigarh", "Dr Cipto Mangunkusumo General Hospital", "Maria Sklodowska-Curie National Research Institute of Oncology", "Chiang Mai University", "Salah Azaïz Cancer Institute", "Wilson Roa Professional Corporation", "Cancer Trials Ireland", "Ege University", "High Technology Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03055208", "BriefTitle": "Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma", "OfficialTitle": "Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma", "OverallStatus": "SUSPENDED", "Phase": [ "NA" ], "StartDate": "2017-02-08", "PrimaryCompletionDate": "2020-03-30", "Interventions": [ { "Name": "gamma knife radiosurgery (15 Gy to 50% isodose)", "Type": "RADIATION", "Description": "Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Universitätsmedizin Mannheim", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00516282", "BriefTitle": "VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma", "OfficialTitle": "A Phase I/II Trial of Cloretazine® (VNP40101M) and Temodar® (Temozolomide) for Patients With Malignant Glioma in First Relapse or Progression", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2007-08", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "CLORETAZINE", "Type": "DRUG", "Description": "CLORETAZINE will be administered intravenously on day 7. The starting dose of CLORETAZINE will be 100 mg/m2 given within 3 hours after the last dose of Temodar on day 7. CLORETAZINE will be given as an IV infusion over 15-30 minutes via a freely flowing peripheral or central intravenous line. CLORETAZINE will be escalated by 50 mg/m2 for the second cohort then by 25 mg/m2 increments in the following cohorts of 3-6 patients using a standard phase I trial design until a MTD is determined. If dose level 2 has two DLTs then patients will be accrued to a new dose level of 125 mg/m2. Prior to receiving Cloretazine, blood will be drawn for gene methylation studies.", "OtherNames": [ "VNP40101M" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Temozolomide will be given orally at a dose of 75mg/m2 daily on day 1 through 7. There will be no dose modification for this agent. Prior to receiving Temozolomide, blood will be drawn for gene methylation studies.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Vion Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01081223", "BriefTitle": "Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma", "OfficialTitle": "Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2011-03", "Interventions": [ { "Name": "Cancer vaccine plus immune adjuvant", "Type": "BIOLOGICAL", "Description": "Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "TVAX Biomedical", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00086879", "BriefTitle": "Erlotinib Compared With Temozolomide or Carmustine in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Randomized Phase II of TARCEVA™ (Erlotinib) Versus Temozolomide Or BCNU in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-05", "PrimaryCompletionDate": "2006-03", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT04583020", "BriefTitle": "Neoadjuvant PD-1 in Newly Diagnosed Glioblastoma", "OfficialTitle": "Neoadjuvant PD-1 in Newly Diagnosed Glioblastoma: A Phase 2 Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-11-12", "PrimaryCompletionDate": "2023-12-30", "Interventions": [ { "Name": "Camrelizumab", "Type": "DRUG", "Description": "Neoadjuvant Camrelizumab 200mg IV, adjuvant Camrelizumab 200mg IV (once every two weeks, until progress)", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "radiation", "Type": "RADIATION", "Description": "60Gy/30", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO during RT 75mg/m2/d; 4 weeks post RT 150-200mg/m2/d days 1-5, 4 weeks/cycle, 6 cycles", "OtherNames": [ "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Peking Union Medical College Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Jiangsu HengRui Medicine Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05168423", "BriefTitle": "CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM", "OfficialTitle": "Phase 1, Open-label Study Evaluating the Safety and Feasibility of CART-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-02-24", "PrimaryCompletionDate": "2039-12-19", "Interventions": [ { "Name": "CART-EGFR-IL13Ra2 Cells", "Type": "DRUG", "Description": "autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR and a humanized scFv targeting IL13Ra2", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "University of Pennsylvania", "LeadSponsorClass": "OTHER", "Collaborators": [ "Kite Pharma (a Gilead Company)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00082797", "BriefTitle": "High-Dose Methotrexate and Leucovorin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study Of Systemic High-Dose Methotrexate For The Treatment Of Glioblastoma Multiforme In Newly Diagnosed Patients With Measurable Disease", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-07-12", "PrimaryCompletionDate": "2007-05", "Interventions": [ { "Name": "leucovorin calcium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "methotrexate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Eastern Cooperative Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT07180927", "BriefTitle": "DLL3 CAR-T Therapy Targeting Brain Tumors", "OfficialTitle": "4sCAR-DLL3 CAR-T Therapy Targeting Brain Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-09-10", "PrimaryCompletionDate": "2028-12-31", "Interventions": [ { "Name": "4SCAR DLL3 T cells", "Type": "BIOLOGICAL", "Description": "Infusion of 4SCAR DLL3 T cells at 10\\^6 cells/kg body weight via intravenous route", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shenzhen Geno-Immune Medical Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01904123", "BriefTitle": "STAT3 Inhibitor WP1066 in Treating Patients With Recurrent Malignant Glioma or Progressive Metastatic Melanoma in the Brain", "OfficialTitle": "A Phase I Trial of WP1066 in Patients With Recurrent Malignant Glioma and Brain Metastasis From Melanoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-07-13", "PrimaryCompletionDate": "2022-03-16", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "STAT3 Inhibitor WP1066", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "WP1066" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03603379", "BriefTitle": "Doxorubicin-loaded Anti-EGFR-immunoliposomes (C225-ILs-dox) in High-grade Gliomas", "OfficialTitle": "A Pharmacokinetic Phase 1 Study of Anti-epidermal Growth Factor Receptor (EGFR) -Immunoliposomes Loaded With Doxorubicin in Patients With Relapsed or Refractory High-grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-11-16", "PrimaryCompletionDate": "2020-11-01", "Interventions": [ { "Name": "C225-ILs-dox", "Type": "DRUG", "Description": "C225-ILs-dox will be administered at a dose of 50 mg/m2. i.v., on day 1 of each cycle, cycle length is 28 days. In total, 4 cycles are planned to be applied.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Basel, Switzerland", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT02381886", "BriefTitle": "A Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations", "OfficialTitle": "A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2015-03-06", "PrimaryCompletionDate": "2016-12-07", "Interventions": [ { "Name": "IDH305", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT00076986", "BriefTitle": "The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "PRECISE - Phase III Randomized Evaluation of Convection Enhanced Delivery of IL13-PE38QQR Compared to GLIADEL® Wafer With Survival Endpoint in Glioblastoma Multiforme Patients at First Recurrence", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2004-02", "PrimaryCompletionDate": "2007-03", "Interventions": [ { "Name": "IL13-PE38QQR", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgery and catheter placement (2 procedures)", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "prolifespan 20 with carmustine implant (GLIADEL® Wafer)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "surgery and wafer placement (1 procedure)", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06325683", "BriefTitle": "Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma", "OfficialTitle": "Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-11-08", "PrimaryCompletionDate": "2028-07-15", "Interventions": [ { "Name": "Biopsy Procedure", "Type": "PROCEDURE", "Description": "Undergo biopsy", "OtherNames": [ "Biopsy", "BIOPSY_TYPE", "Bx" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea", "1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-", "Belustin", "Belustine", "CCNU", "Cecenu", "CeeNU", "Chloroethylcyclohexylnitrosourea", "Citostal", "Gleostine", "Lomeblastin", "Lomustinum", "Lucostin", "Lucostine", "N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea", "Prava", "RB-1509", "WR-139017" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 206", "BCD-263", "BMS 936558", "BMS-936558", "BMS936558", "CMAB819", "MDX 1106", "MDX-1106", "MDX1106", "NIVO", "Nivolumab Biosimilar ABP 206", "Nivolumab Biosimilar BCD-263", "Nivolumab Biosimilar CMAB819", "ONO 4538", "ONO-4538", "ONO4538", "Opdivo" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Relatlimab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "BMS 986016", "BMS-986016", "BMS986016", "Immunoglobulin G4, Anti-(human Lymphocyte Activation Gene-3 Protein) (Human Heavy Chain), Disulfide with Human Light Chain, Dimer" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Surgical Procedure", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [ "Operation", "Surgery", "Surgery Type", "Surgery, NOS", "Surgical", "Surgical Intervention", "Surgical Interventions", "Surgical Procedures", "Type of Surgery" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT04552886", "BriefTitle": "Dendritic Cell Vaccination With Standard Postoperative Chemoradiation for the Treatment of Adult Glioblastoma", "OfficialTitle": "A Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemoradiation for the Adjuvant Treatment of Adult Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2021-10-11", "PrimaryCompletionDate": "2023-12-01", "Interventions": [ { "Name": "TH-1 Dendritic Cell Immunotherapy", "Type": "BIOLOGICAL", "Description": "Adult patients with histopathologically diagnosed glioblastoma will be eligible for this novel, personalized dendritic cell vaccine after completing standard of care chemoradiation.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The Cooper Health System", "LeadSponsorClass": "OTHER", "Collaborators": [ "Baylor College of Medicine", "Philadelphia College of Osteopathic Medicine" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04385173", "BriefTitle": "Pilot Study of B7-H3 CAR-T in Treating Patients With Recurrent and Refractory Glioblastoma", "OfficialTitle": "A Pilot Study of Chimeric Antigen Receptor (CAR) T Cells Targeting B7-H3 Antigen in Treating Patients With Recurrent and Refractory Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2022-12-01", "PrimaryCompletionDate": "2024-03-01", "Interventions": [ { "Name": "B7-H3 CAR-T", "Type": "DRUG", "Description": "The B7-H3 CAR-T will be administrated via intratumoral or Intracerebroventricular injection through an Ommaya catheter in between Temozolomide cycles. Temozolomide will be stopped during the infusion of B7-H3 CAR-T", "OtherNames": [ "BP102" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be given to patients orally every 5 days with 23 days interval. The initial dose is 150 mg/m2 on the first day and 200 mg/m2 for the rest if no toxicity is seen. If 200 mg/m2 is toxic, the drug will return to 150 mg/m2 or will be stopped.", "OtherNames": [ "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [ "BoYuan RunSheng Pharma (Hangzhou) Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03390569", "BriefTitle": "Exercise in Patients With Glioblastoma", "OfficialTitle": "Does Exercise Improve Progression-free Survival in Glioblastoma? A Prospective Single Arm Intervention Trial", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-08-29", "PrimaryCompletionDate": "2021-08-31", "Interventions": [ { "Name": "Exercise", "Type": "BEHAVIORAL", "Description": "The patients meet with a registered physiotherapist and receive individualized exercise programs starting the second week of treatment, and continuing up to 3 months later.", "OtherNames": [ "Fitness", "Physiotherapy" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Health Network, Toronto", "LeadSponsorClass": "OTHER", "Collaborators": [ "Canadian Cancer Society (CCS)", "University of Toronto", "McMaster University", "University of British Columbia" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02238496", "BriefTitle": "Perifosine and Torisel (Temsirolimus) for Recurrent/Progressive Malignant Gliomas", "OfficialTitle": "Pilot Trial of Temsirolimus and Perifosine in Recurrent/Progressive Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-12-08", "PrimaryCompletionDate": "2017-10-27", "Interventions": [ { "Name": "Cytoreductive surgery", "Type": "PROCEDURE", "Description": "Standard of care/routine cytoreductive glioma resection surgery. Arm B only.", "OtherNames": [ "Resection" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Perifosine", "Type": "DRUG", "Description": "Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow.", "OtherNames": [ "AEZS-104/D-21266", "KRX-0401" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Temsirolimus", "Type": "DRUG", "Description": "Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors.", "OtherNames": [ "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Andrew B Lassman, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer", "AEterna Zentaris" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT01790503", "BriefTitle": "A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-07-18", "PrimaryCompletionDate": "2017-11-03", "Interventions": [ { "Name": "PLX3397", "Type": "DRUG", "Description": null, "OtherNames": [ "Pexidartinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "TMZ", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Daiichi Sankyo", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Plexxikon" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00293423", "BriefTitle": "GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma", "OfficialTitle": "Phase I/II Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine for Patients With Recurrent High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-11-18", "PrimaryCompletionDate": "2013-01-12", "Interventions": [ { "Name": "HSPPC-96", "Type": "BIOLOGICAL", "Description": "25 mcg", "OtherNames": [ "Heat Shock", "Glycoprotein 96", "Gp96" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standard Surgical Resection", "Type": "PROCEDURE", "Description": "Patients will undergo standard surgical resection of intracranial tumor", "OtherNames": [ "Craniotomy" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Agenus Inc.", "American Brain Tumor Association" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06419946", "BriefTitle": "Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma", "OfficialTitle": "Phase III Trial of Temozolomide/Lomustine (TMZ/LOM) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT Promoter Methylated Glioblastoma (IDHwt) Patients +/- Tumor Treating Fields (Optune)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-12-01", "PrimaryCompletionDate": "2028-12-15", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "In the experimental treatment arm: a combination of Temozolomide and Lomustine, taken together, two separate pills", "OtherNames": [ "LOM" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Vastra Gotaland Region", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "Skane University Hospital", "Gävle Hospital", "Karolinska Institutet", "Sahlgrenska University Hospital", "Karlstad Central Hospital", "Ryhov County Hospital", "Kalmar County Hospital", "Oslo University Hospital", "St. Olavs Hospital", "Haukeland University Hospital", "Sorlandet Hospital HF", "Helse Stavanger HF", "Aarhus University Hospital", "University Hospital, Umeå", "Eskilstuna Lasarettet", "Region Örebro County" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04013672", "BriefTitle": "Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence", "OfficialTitle": "Phase II Study of Pembrolizumab Plus SurVaxM for Glioblastoma at First Recurrence", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-03-19", "PrimaryCompletionDate": "2021-08-16", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "200 mg IV every 3 weeks", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "SurVaxM", "Type": "DRUG", "Description": "500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months", "OtherNames": [ "SVN53-67", "M57-KLH" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Sargramostim", "Type": "DRUG", "Description": "100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months", "OtherNames": [ "GM-CSF" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Montanide ISA 51", "Type": "DRUG", "Description": "1 ml per dose dosed every two weeks for 4 doses and then every 3 months", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "David Peereboom", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT04681677", "BriefTitle": "Recurrent GBM Treated With Neurosurgical Resection and IORT Using the Xoft Axxent eBx System and Bevacizumab", "OfficialTitle": "Phase II Study of Patients With Recurrent Glioblastoma Multiforme Treated With Maximal Safe Neurosurgical Resection and Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent Electronic Brachytherapy System and Bevacizumab", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2021-11-02", "PrimaryCompletionDate": "2024-04-24", "Interventions": [ { "Name": "Radiation: Intra-operative Radiation Therapy - IORT", "Type": "RADIATION", "Description": "Single fraction, Intra-operative Radiation Therapy at the time of surgical resection of recurrent GBM followed by Bevacizumab 28-56 days after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Xoft, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Icad, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03422094", "BriefTitle": "Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OfficialTitle": "A Pilot Study to Assess the Safety, Feasibility, and Immunogenicity of a Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-10-31", "PrimaryCompletionDate": "2020-04-26", "Interventions": [ { "Name": "NeoVax", "Type": "BIOLOGICAL", "Description": "At each vaccination time point, patients will receive up to 20 synthetic long peptides co-administered with 1.5 mg of poly-ICLC divided into a maximum of four injections (pools). Each pool (of vaccine + poly IC:LC) will be administered to one of the four limbs (right axilla, left axilla, right inguina, left inguina) by subcutaneous injection.", "OtherNames": [ "Synthetic long peptides plus poly-ICLC" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Ipilimumab", "Type": "BIOLOGICAL", "Description": "Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)", "OtherNames": [ "Yervoy" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Research blood draw", "Type": "PROCEDURE", "Description": "-Baseline, cycle 2 day 1, cycle 4 day 1, and time of progression or discontinuation of treatment", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Leukapheresis for research", "Type": "PROCEDURE", "Description": "-Baseline, cycle 4 day 1, and time of progression or discontinuation of treatment", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00892177", "BriefTitle": "Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme", "OfficialTitle": "Phase I/Randomized Phase II Double Blind Study of Either Dasatinib or Placebo Combined With Bevacizumab in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-10", "PrimaryCompletionDate": "2014-11", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Given intravenously", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "dasatinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "placebo", "Type": "OTHER", "Description": "Given orally", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT02015819", "BriefTitle": "Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin for Treating Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I Study of Cytosine Deaminase-Expressing Neural Stem Cells in Combination With Oral 5-Fluorocytosine and Leucovorin for the Treatment of Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-10-07", "PrimaryCompletionDate": "2017-10-07", "Interventions": [ { "Name": "E. coli CD-expressing genetically modified neural stem cells", "Type": "BIOLOGICAL", "Description": "Given intracranially", "OtherNames": [ "HB1.F3.CD neural stem cells" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "flucytosine", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "5-FC", "5-fluorocytosine", "Ro 2-9915" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "leucovorin calcium", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CF", "CFR", "LV" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00597402", "BriefTitle": "Avastin in Combination With Radiation (XRT) & Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma (GBM) and Gliosarcomas", "OfficialTitle": "Avastin in Combination With Radiation and Temozolomide, Followed by Avastin, Temozolomide and Irinotecan for Glioblastoma Multiformes and Gliosarcomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-07", "PrimaryCompletionDate": "2011-08", "Interventions": [ { "Name": "Avastin", "Type": "DRUG", "Description": "Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury. Following completion of XRT, patients will receive treatment that includes 6 cycles of Avastin, beginning a minimum of 14 days after last XRT.", "OtherNames": [ "Bevacizumab" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Daily temozolomide 75 mg/m2/day for 6.5 weeks of radiation treatment. Following completion of XRT, patients will receive treatment including temozolomide 200 mg/m2/day on the 1st 5 days of each 28-day cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Radiation Therapy (XRT)", "Type": "RADIATION", "Description": "Treatment with standard XRT (radiation) for 6.5 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Following completion of XRT, patients will receive 6 cycles of treatment that includes irinotecan. Beginning a minimum of 14 days after last XRT, the irinotecan dose will depend on whether the patient is on enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED: 125 mg/m2.)", "OtherNames": [ "CPT-11", "Camptosar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04218019", "BriefTitle": "Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation", "OfficialTitle": "Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation in Elderly Patients With Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2023-08-01", "PrimaryCompletionDate": "2023-08-01", "Interventions": [ { "Name": "TTFields", "Type": "DEVICE", "Description": "The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Juergen Debus", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00941460", "BriefTitle": "Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma", "OfficialTitle": "Dose-intensified Rechallenge With Temozolomide, One Week On One Week Off Versus Three Weeks On One Week Off in Patients With Progressive or Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "Temozolomide in both arms", "Type": "DRUG", "Description": "initial dose 120 mg/m2 in arm A", "OtherNames": [ "Temodal" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide in both arms", "Type": "DRUG", "Description": "initial dose 80 mg/m2 in arm B", "OtherNames": [ "Temodal" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Prof. Dr. Wolfgang Wick", "LeadSponsorClass": "OTHER", "Collaborators": [ "Essex Pharma GmbH" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00650923", "BriefTitle": "Aflibercept, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma Multiforme, Gliosarcoma, or Other Malignant Glioma", "OfficialTitle": "Phase I Trial of Aflibercept (VEGF Trap) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "ziv-aflibercept", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "aflibercept", "vascular endothelial growth factor trap", "VEGF Trap", "Zaltrap" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "PROCEDURE", "Description": "Undergo RT", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06616727", "BriefTitle": "The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the rGBM", "OfficialTitle": "A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SNC109 in Patients With Recurrent Glioblastoma", "OverallStatus": "ENROLLING_BY_INVITATION", "Phase": [ "PHASE1" ], "StartDate": "2023-12-26", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "SNC109", "Type": "DRUG", "Description": "SNC-109 CAR-T Cells, first dose from 5×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shanghai Simnova Biotechnology Co.,Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03539731", "BriefTitle": "[18F]DASA-23 and PET Scan in Evaluating Pyruvate Kinase M2 Expression in Patients With Intracranial Tumors or Recurrent Glioblastoma and Healthy Volunteers", "OfficialTitle": "A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-04-23", "PrimaryCompletionDate": "2022-12-31", "Interventions": [ { "Name": "Fluorine F 18 DASA-23", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "[18F]DASA-23; [18F]DASA23; 18F-DASA-23; 1-((2-Fluoro-6-[18F]fluorophenyl)sulfonyl)-4-((4-methoxyphenyl)sulfonyl)piperazine; F18-labeled Pyruvate Kinase M2 Inhibitor DASA-23; F18-labeled PKM2 Inhibitor" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET scan", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Guido A. Davidzon, MD, SM", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00276783", "BriefTitle": "Pemetrexed Disodium in Treating Patients With Recurrent Malignant Gliomas, Primary CNS Lymphoma, or Brain Metastases", "OfficialTitle": "A Phase II Trial of Alimta (Pemetrexed) in Patients With Recurrent Malignant Gliomas, Primary Central Nervous System Lymphoma, and Brain Metastases", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2005-11", "PrimaryCompletionDate": "2022-12", "Interventions": [ { "Name": "pemetrexed", "Type": "DRUG", "Description": "Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.", "OtherNames": [ "pemetrexed disodium", "Alimta" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06973096", "BriefTitle": "CART-EGFR-IL13Ra2 in Newly Diagnosed GBM Following Initial Radiotherapy", "OfficialTitle": "Phase 1 Open-label Study Evaluating the Safety of CART-EGFR-IL13Rα2 Cells in Patients With Newly Diagnosed, EGFR-Amplified, MGMT-unmethylated Glioblastoma Following Completion of Initial Radiotherapy", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-18", "PrimaryCompletionDate": "2042-07", "Interventions": [ { "Name": "CART-EGFR-IL13Ra2 cells", "Type": "DRUG", "Description": "autologous T cells transduced with a bicistronic lentiviral vector containing a murine scFv targeting EGFR epitope 806 and a humanized scFv targeting IL13Ra2; both scFvs are fused to the 4-1BB and CD3ζ signaling domains.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "University of Pennsylvania", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT00006024", "BriefTitle": "Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma", "OfficialTitle": "A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2000-11", "PrimaryCompletionDate": "2005-01", "Interventions": [ { "Name": "lomustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01996527", "BriefTitle": "3T MRI Biomarkers of Glioma Treatment Response", "OfficialTitle": "Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2012-05", "PrimaryCompletionDate": "2015-11-23", "Interventions": [ { "Name": "3-Tesla magnetic resonance imaging", "Type": "DEVICE", "Description": "3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI", "OtherNames": [ "3-Tesla MRI", "3T MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "CEST-MRI", "Type": "DEVICE", "Description": "Undergo CEST-MRI", "OtherNames": [ "chemical exchange saturation transfer MRI" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "DW-MRI", "Type": "DEVICE", "Description": "Undergo DWI-MRI", "OtherNames": [ "diffusion-weighted MRI" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "DCE-MRI", "Type": "DEVICE", "Description": "Undergo DCE-MRI", "OtherNames": [ "dynamic contrast-enhanced MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "DSC-MRI", "Type": "DEVICE", "Description": "Undergo DSC-MRI", "OtherNames": [ "dynamic susceptibility contrast MRI" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "IV administration of gadolinium-containing contrast agent", "Type": "DRUG", "Description": "Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast", "OtherNames": [ "Magnevist®", "gadopentetate dimeglumine" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Vanderbilt-Ingram Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05718466", "BriefTitle": "Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy", "OfficialTitle": "Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2010-11", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Chemotherapy", "Type": "DRUG", "Description": null, "OtherNames": [ "Either irinotecan or temozolomide or carboplatin or etoposide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Fractionated radiosurgery", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Henry Ford Health System", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00404248", "BriefTitle": "Tetra-O-Methyl Nordihydroguaiaretic Acid in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "Phase I/II Study of Intravenous Infusion of Tetra-o-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Recurrent High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-01", "PrimaryCompletionDate": "2009-06", "Interventions": [ { "Name": "terameprocol", "Type": "DRUG", "Description": "terameprocol will be given IV 5 consecutive days every 28 days. Starting dose 750mg/day. Cohorts of 3pts. A Dose Limiting Toxicity (DLT) target rate of Less than or equal to 33%. Dose levels: 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, 9300 mg.", "OtherNames": [ "EM-1421" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "All pts on both arms will have pks, blood collections. 5ml of blood will be drawn on Cycle 1 day 1, Cycle 1 Day 5, Cycle 2 day 1 and Cycle 2 day 5. A total of 10 samples will be drawn at each of these time points. 1hr pre-infusion, 15 min, 1hr, 1.15, 1.5, 2, 3,4,6 and 24hr post infusion.", "OtherNames": [ "PK" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05106296", "BriefTitle": "Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer", "OfficialTitle": "Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-02-08", "PrimaryCompletionDate": "2028-03-30", "Interventions": [ { "Name": "Indoximod", "Type": "DRUG", "Description": "Indoximod will be taken by mouth twice daily, throughout each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Ibrutinib", "Type": "DRUG", "Description": "For Regimen A, Ibrutinib will be taken by mouth once daily, on days 1-21 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Etoposide", "Type": "DRUG", "Description": "Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Ibrutinib", "Type": "DRUG", "Description": "For Regimen B, Ibrutinib will be taken by mouth once daily, on days 1-14 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Theodore S. Johnson", "LeadSponsorClass": "OTHER", "Collaborators": [ "Augusta University", "CureSearch for Children's Cancer", "Rally Foundation for Childhood Cancer Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00626483", "BriefTitle": "Basiliximab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Targeted Immunotherapy and Temozolomide-Caused Lymphopenia", "OfficialTitle": "REGULATory T-Cell Inhibition With Basiliximab (Simulect®) During Recovery From Therapeutic Temozolomide-induced Lymphopenia During Antitumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-04-24", "PrimaryCompletionDate": "2016-07-06", "Interventions": [ { "Name": "RNA-loaded dendritic cell vaccine", "Type": "BIOLOGICAL", "Description": "Only one dose of DCs (2 x 10\\^7) is being assessed.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "basiliximab", "Type": "DRUG", "Description": "Basiliximab 20 mg and 40 mg is being assessed depending on dose-cohort enrollment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Gary Archer Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04118036", "BriefTitle": "Abemaciclib + Pembrolizumab In Glioblastoma", "OfficialTitle": "A Phase 2 Study of Abemaciclib and Pembrolizumab in Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2021-12-01", "PrimaryCompletionDate": "2023-12-01", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "intravenously over 30 minutes every 21 days (+/- 3 days)", "OtherNames": [ "Keytruda" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK", "PD-1" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Abemaciclib", "Type": "DRUG", "Description": "Oral 2 times a day", "OtherNames": [ "Verzenio" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK", "PD-1" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "PD-1" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT03975829", "BriefTitle": "Pediatric Long-Term Follow-up and Rollover Study", "OfficialTitle": "An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE4" ], "StartDate": "2019-11-04", "PrimaryCompletionDate": "2026-06-23", "Interventions": [ { "Name": "dabrafenib", "Type": "DRUG", "Description": "dabrafenib oral, twice daily", "OtherNames": [ "DRB436" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "trametinib", "Type": "DRUG", "Description": "trametinib oral, once daily", "OtherNames": [ "TMT212" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05140902", "BriefTitle": "Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom", "OfficialTitle": "Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2022-03-28", "PrimaryCompletionDate": "2024-08-25", "Interventions": [ { "Name": "Point-of-care Portable Perfusion Phantom (P4)", "Type": "DEVICE", "Description": "P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Center for Advancing Translational Sciences (NCATS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01013285", "BriefTitle": "Bevacizumab, Temozolomide, and External Beam Radiation Therapy as First-Line Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase II Trial of Bevacizumab in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-06", "PrimaryCompletionDate": "2013-10", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "external beam radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02085304", "BriefTitle": "Tumor Resection and Gliadel® Wafers, Followed by Temodar® With Standard Radiation or GammaKnife® for New GBM", "OfficialTitle": "Phase I/II Randomized Prospective Trial for Newly Diagnosed GBM, With Upfront Gross Total Resection, Gliadel®, Followed by Temodar® With Concurrent IMRT Versus GK", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-05-07", "PrimaryCompletionDate": "2015-05-30", "Interventions": [ { "Name": "Gross total resection and Gliadel(R) wafers implanted", "Type": "PROCEDURE", "Description": "Complete removal of tumor and implant of Gliadel(R) wafers that are small, dime-sized wafers designed to deliver the chemo drug, carmustine, directly into the cavity made when the brain tumor was removed.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "GammaKnife(R) stereotactic Radiosurgery", "Type": "RADIATION", "Description": "GammaKnife® (GK) radiosurgery dose of 15 Gy in one fraction to the resection cavity margin", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard fractionated radiation therapy", "Type": "RADIATION", "Description": "standard fractionated RT of 60 Gy in 30 fractions (over approximately six weeks)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "temozolomide 75 mg/m2 daily for 42 days, will be administered to all patients beginning within 24 hours of GK/RT initiation as is routine clinical care. There will be a one month drug holiday following the 42 days before adjuvant chemotherapy begins. Adjuvant temozolomide administered 5 days monthly at 150-200 mg/m2/day will be administered for 12 months as is routine clinical care.", "OtherNames": [ "Temodar(R)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03797326", "BriefTitle": "Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)", "OfficialTitle": "A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2019-02-12", "PrimaryCompletionDate": "2024-10-28", "Interventions": [ { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Administered as an IV infusion on Day 1 Q3W.", "OtherNames": [ "MK-3475", "Keytruda®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lenvatinib", "Type": "DRUG", "Description": "Administered orally once a day during each 21-day cycle.", "OtherNames": [ "MK-7902", "E7080", "LENVIMA™" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Eisai Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03749187", "BriefTitle": "BGB-290 and Temozolomide in Treating Isocitrate Dehydrogenase (IDH)1/2-Mutant Grade I-IV Gliomas", "OfficialTitle": "A Target Validation/Phase1 Study of BGB-290 in Combination With Temozolomide in Adolescent and Young Adult IDH1/2 Newly Diagnosed and Recurrent Mutant Gliomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-04-03", "PrimaryCompletionDate": "2026-06-30", "Interventions": [ { "Name": "PARP Inhibitor BGB-290", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BGB-290", "Pamiparib" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "BeiGene USA, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT02386826", "BriefTitle": "INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase Ib Study Evaluating the c-Met Inhibitor INC280 in Combination With Bevacizumab in Patients With Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-09-22", "PrimaryCompletionDate": "2021-07-31", "Interventions": [ { "Name": "INC280", "Type": "DRUG", "Description": "Dose Escalation: INC280 by mouth (PO) twice daily for 28 days according to the following schedule until the maximum tolerated dose (MTD) is determined:\n\nDose Level 1 (starting dose): 200 mg (divided dose of 100 mg twice per day) Dose Level 2: 400 mg (divided dose of 200 mg twice per day) Dose Level 3: 800 mg (divided dose of 400 mg twice per day)\n\nDose Expansion: INC280 PO twice daily at the MTD determined in the dose escalation phase", "OtherNames": [ "INCB28060" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "bevacizumab: 10 mg/kg IV every 2 weeks. Patients with unresectable GBM will be given 15 mg/kg IV every 4 weeks.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "SCRI Development Innovations, LLC", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03970447", "BriefTitle": "A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma", "OfficialTitle": "GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2019-07-30", "PrimaryCompletionDate": "2028-06", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg", "OtherNames": [ "Temodar", "Temodal", "Temcad" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg", "OtherNames": [ "CCNU", "CeeNU", "Gleostine" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Regorafenib", "Type": "DRUG", "Description": "Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)", "OtherNames": [ "Stivarga", "BAY 73-4506" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "60 Gy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Paxalisib", "Type": "DRUG", "Description": "Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles", "OtherNames": [ "GDC-0084" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "VAL-083", "Type": "DRUG", "Description": "Dosage Form: Infusion for intravenous administration Strength: 40 mg per vial Standard Regimen: 30 mg/m2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg/m2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.", "OtherNames": [ "Dianhydrogalactitol" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "VT1021", "Type": "DRUG", "Description": "Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).\n\nStandard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Troriluzole", "Type": "DRUG", "Description": "Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.", "OtherNames": [ "BHV-4157" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "ADI-PEG 20", "Type": "BIOLOGICAL", "Description": "Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week", "OtherNames": [ "Pegargiminase" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "AZD1390", "Type": "DRUG", "Description": "Standard Regimen Newly Diagnosed: Given once daily on days of radiation and once daily for 14 consecutive days after completion of radiation.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Global Coalition for Adaptive Research", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bayer", "Kazia Therapeutics Limited", "Kintara Therapeutics, Inc.", "Biohaven Pharmaceuticals, Inc.", "Vigeo Therapeutics, Inc.", "Polaris Group", "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04116138", "BriefTitle": "Antisecretory Factor in Primary Glioblastoma 1", "OfficialTitle": "Antisecretory Factor, Administered as an Enriched Egg Powder, Salovum®, as Supplementary Therapy for Primary Glioblastoma During Concomitant Radio-chemotherapy.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-09-01", "PrimaryCompletionDate": "2021-03-31", "Interventions": [ { "Name": "Salovum", "Type": "DIETARY_SUPPLEMENT", "Description": "Egg yolk powder enriched for anti secretory factor", "OtherNames": [ "Antisecretory factor" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Peter Siesjö", "LeadSponsorClass": "OTHER", "Collaborators": [ "Region Skane", "Lund University", "Skane University Hospital", "Lantmannen Medical AB" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00046878", "BriefTitle": "Carmustine and O(6)-Benzylguanine in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme", "OfficialTitle": "Phase 2 Trial of BCNU Plus O6-Benzylguanine (NSC 637037) in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": null, "PrimaryCompletionDate": null, "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01454596", "BriefTitle": "CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII", "OfficialTitle": "A Phase I/II Study of the Safety and Feasibility of Administering T Cells Expressing Anti-EGFRvIII Chimeric Antigen Receptor to Patients With Malignant Gliomas Expressing EGFRvIII", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-05-16", "PrimaryCompletionDate": "2018-11-01", "Interventions": [ { "Name": "Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL", "Type": "BIOLOGICAL", "Description": "Day 0: Cells will be infused intravenously over 20-30 minutes. Patients will receive two cell doses, 2 hours apart.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Aldesleukin", "Type": "DRUG", "Description": "Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).", "OtherNames": [ "Proleukin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Fludarabine", "Type": "DRUG", "Description": "Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.", "OtherNames": [ "Fludara" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.", "OtherNames": [ "Cytoxan" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00238303", "BriefTitle": "Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-09", "PrimaryCompletionDate": "2008-07", "Interventions": [ { "Name": "vorinostat", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "L-001079038", "SAHA", "suberoylanilide hydroxamic acid", "Zolinza" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": "Patients undergo surgery to remove tumor", "OtherNames": [ "surgery, conventional" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05734560", "BriefTitle": "D2C7-IT and 2141-V11 in Newly Diagnosed GBM Patients", "OfficialTitle": "Delivery of D2C7-IT and 2141-V11 Combination Immunotherapy in Residual Disease for Adult Patients With Newly Diagnosed MGMT Unmethylated Glioblastoma and Perilymphatic Subcutaneous Injections of 2141-V11", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-09-06", "PrimaryCompletionDate": "2026-10-31", "Interventions": [ { "Name": "D2C7-IT", "Type": "DRUG", "Description": "D2C7-IT will be dosed at 166,075 ng in 36 mL.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "2141-V11", "Type": "DRUG", "Description": "2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rockefeller University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT03363659", "BriefTitle": "Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme", "OfficialTitle": "A Phase II, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients With Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2018-03-28", "PrimaryCompletionDate": "2022-01-13", "Interventions": [ { "Name": "Disulfiram", "Type": "DRUG", "Description": "Disulfiram is taken orally, twice daily.", "OtherNames": [ "Antabuse" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Copper gluconate", "Type": "DIETARY_SUPPLEMENT", "Description": "Copper gluconate is taken orally, twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is taken once daily", "OtherNames": [ "Temodar, Temodal, Temcad" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02157103", "BriefTitle": "A Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma", "OfficialTitle": "A Phase II Study of Subcutaneous Bevacizumab in Relapsed / Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2016-11", "Interventions": [ { "Name": "Bevacizumab 25 mg in 1 ml subcutaneously daily", "Type": "DRUG", "Description": "Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00052624", "BriefTitle": "Immunotoxin Therapy in Treating Children With Progressive or Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma", "OfficialTitle": "A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2002-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "transferrin-CRM107", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Xenova Biomedix", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05241392", "BriefTitle": "Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma", "OfficialTitle": "An Open, Single-arm, Phase 1 Study to Evaluate the Safety/Preliminary Effectiveness and Determine the Maximal Tolerated Dose of B7-H3-targeting CAR-T Cell Therapy in Treating Recurrent Glioblastomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-01-27", "PrimaryCompletionDate": "2024-11-30", "Interventions": [ { "Name": "B7-H3-targeting CAR-T cells", "Type": "BIOLOGICAL", "Description": "Patients will be treated with anti-B7-H3 autologous CAR-T cells that are delivered into the intracranial tumor resection cavity or ventricular system using an Ommaya device.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01006044", "BriefTitle": "Efficacy & Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme After Complete Surgical Resection", "OfficialTitle": "Prospective, Phase II Clinical Trial to Evaluate Efficacy and Safety of Autologous Dendritic Cell Vaccination in Glioblastoma Multiforme Patients After Complete Surgical Resection With Fluorescence Microscope", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-10", "PrimaryCompletionDate": "2014-08", "Interventions": [ { "Name": "autologous dendritic cells", "Type": "BIOLOGICAL", "Description": "Patients will receive standard first-line therapy (surgery before radio-chemotherapy) along with the experimental treatment. The experimental treatment consists in subcutaneous vaccination with a suspension of autologous dendritic cells (cells from the same patient) produced by cell culture from monocytes from the same patient extracted by leukapheresis and pulsed with a lysate of the patient´s tumoral tissue. The first four vaccines will be administered on a monthly basis, concomitantly with the standard chemo and radiotherapy treatments, the next four vaccines, every other month and the four last vaccinations every three months.The results obtained will be compared with those of an historical control study, where patients received a standard treatment without the experimental vaccine.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Clinica Universidad de Navarra, Universidad de Navarra", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01866449", "BriefTitle": "Prospective Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme", "OfficialTitle": "Prospective Controlled Phase 2 Trial of Cabazitaxel in Patients With Temozolomide Refractory Glioblastoma Multiforme (GBM)- The C-GBM Study -", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-10", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "Cabazitaxel", "Type": "DRUG", "Description": null, "OtherNames": [ "Jevtane" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Ulm", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00062504", "BriefTitle": "Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas", "OfficialTitle": "A Phase II Trial of Talampanel in Patients With Recurrent High-Grade Gliomas.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2003-07", "PrimaryCompletionDate": "2006-01", "Interventions": [ { "Name": "Talampanel", "Type": "DRUG", "Description": "10mg, 25 mg, 35 mg, 50 mg, 75mg TID for 3 weeks", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Teva Branded Pharmaceutical Products R&D, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04471844", "BriefTitle": "Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM", "OfficialTitle": "EF-32: Pivotal, Randomized, Open-Label Study of Optune® (Tumor Treating Fields, 200kHz) Concomitant With Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-12-08", "PrimaryCompletionDate": "2026-01-30", "Interventions": [ { "Name": "Optune®", "Type": "DEVICE", "Description": "Optune® is a commercial, portable, battery-operated device intended for continuous home use, which delivers TTFields at a frequency of 200kHz to the brain by means of insulated transducer arrays. The Optune® device produces electric forces intended to disrupt cancer cell division.\n\nIn treatment arm I, the patient starts Optune® concurrently with RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.\n\nIn treatment arm II, the patient starts RT/TMZ for 6 weeks, followed by Optune® + TMZ until second disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NovoCure Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00624728", "BriefTitle": "Assessment of 18FLT PET-CT for Volume Definition of High-grade Gliomas (GLIO-TEP)", "OfficialTitle": "Assessment of 18Fluoro-thymidine PET-CT for the Volume Definition of High-grade Gliomas (GLIO-TEP) : Correlation With Histopathology", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-02", "PrimaryCompletionDate": "2011-11", "Interventions": [ { "Name": "18F Fluorothymidine PET CT", "Type": "RADIATION", "Description": "18 FLT will be provided by the Laboratoire des Radiopharmaceutiques- Université Bordeaux2, Hôpital Xavier Arnozan and prepared according to the method described by Grierson and Shields ( Grierson J, Shields A. Nucl Med Biol 27 :143-156 ; 2000).\n\nSpecific activity of 18FLT will be more than 37 GBq/µmol (\\>1Ci/µmol) corrected for decay at the end of bombardment of cyclotron target. Before tracer injection to patients, each dosis will be tested for pH and for radiochemical purity (\\> 95%) via HPLC technique and thin layer chromatography.\n\n18FLT dosis will be injected intravenously to the patients (10 mL of salted isotonic solution with less than 10 % (v/v) of ethanol (USP). Administrated activity will be calculated estimating total body surface of patient (2,6 MBq/kg ou 0,07 mCi/kg) with maximal activity of 185 MBq.\n\nPET acquisition will be realized as follows : Dynamic acquisition in 3D mode for 35 min, Iterative reconstruction (OSEM) with and without attenuation correction.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Bordeaux", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00756106", "BriefTitle": "MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma", "OfficialTitle": "Quantitative Assessment of the Early and Late Effects of Radiation and Chemotherapy on Glioblastoma Using Multiple MRI Techniques", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2012-02", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "Temozolomide is administered according to standard of care practice guidelines. Dosing may be modified at the discretion of the treating investigator.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Imaging biomarker analysis", "Type": "OTHER", "Description": "MRI", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Photon Radiation Therapy", "Type": "RADIATION", "Description": "Radiation is administered to the tumor plus edema with a 1-2 centimeter margin for a total dose of 60 Gy in 30 fractions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00036894", "BriefTitle": "CC-5013 in Treating Patients With Recurrent Glioma", "OfficialTitle": "A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-03", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "lenalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01242566", "BriefTitle": "Temozolomide in Elderly Patients With KPS < 70", "OfficialTitle": "Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-07", "PrimaryCompletionDate": "2010-05", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "orally 150-200 mg/m2/day for 5 consecutive days every 4 week", "OtherNames": [ "Temodar, Temodal" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [ "Association de Neuro-Oncologues d'Expression Francaise" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00360945", "BriefTitle": "Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma", "OfficialTitle": "Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2004-04", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "cisplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "fluorescence in situ hybridization", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "loss of heterozygosity analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Cancer and Leukaemia Group", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00445965", "BriefTitle": "Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer", "OfficialTitle": "Phase II Study of Intrathecal I-3F8 in Patients With GD2-Expressing Central Nervous System and Leptomeningeal Neoplasms", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-01", "PrimaryCompletionDate": "2023-02-01", "Interventions": [ { "Name": "DNA analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "immunologic technique", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 131 monoclonal antibody 3F8", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "131I-3F8", "Type": "RADIATION", "Description": "Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03862430", "BriefTitle": "A Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM", "OfficialTitle": "A Phase II Double-blind, RandomizEd, Prospective, Placebo Controlled STudy of NanO2TM Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma multiformE: RESTORE", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-03-31", "PrimaryCompletionDate": "2026-06-30", "Interventions": [ { "Name": "NanO2TM", "Type": "DRUG", "Description": "0.1 mL/kg NanO2 infusion", "OtherNames": [ "Dodecafluoropentane emulsion (DDFPe)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo Saline Infusion", "Type": "DRUG", "Description": "Saline Infusion", "OtherNames": [ "0.9N NaCl" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NuvOx LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01756729", "BriefTitle": "Post-approval Study of NovoTTF-100A in Recurrent GBM Patients", "OfficialTitle": "A Prospective, Non-randomized, Concurrent Control, Open Label, Post-approval Study of NovoTTF-100A in Recurrent GBM Patient", "OverallStatus": "TERMINATED", "Phase": [ "PHASE4" ], "StartDate": "2012-12", "PrimaryCompletionDate": "2018-01", "Interventions": [ { "Name": "NovoTTF-100A", "Type": "DEVICE", "Description": "Multiple four-week courses of continuous NovoTTF-100A treatment.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NovoCure Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06477939", "BriefTitle": "Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients", "OfficialTitle": "Phase III Randomized Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients to Evaluate Efficacy and Safety", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-01-01", "PrimaryCompletionDate": "2032-12-31", "Interventions": [ { "Name": "Administration of L-TC", "Type": "DRUG", "Description": "Administration of L-TC (300 mg) as an IV perfusion, before each radiotion session\n\nRadiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week\n\n\\+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy plus Temozolomide", "Type": "OTHER", "Description": "Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week\n\n\\+ Temozolomide delivered at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy, but for no longer than 25 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Institut de cancérologie Strasbourg Europe", "LeadSponsorClass": "OTHER", "Collaborators": [ "LEAF4Life, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06781372", "BriefTitle": "Patient's Derived Organoids for Drug Screening in Glioblastoma", "OfficialTitle": "Development and Characterization of Patient's Derived Organoids as a Platform for the Screening of Novel Therapeutic Treatments for Glioblastoma Multiforme", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-04-01", "PrimaryCompletionDate": "2028-01-31", "Interventions": [ { "Name": "Development and characterization of PDOs", "Type": "BIOLOGICAL", "Description": "An amount of tissue of approximately 2-3 cm3, if available, will be allocated to the study. The specimen will be divided in three parts (depending on the volume of the biopsy) and used to: a) obtain PDOs according to established procedures (Chadwick, et al., 2020; Gamboa, et al., 2021); b) flash-frozen for molecular analysis of original tissue; c) used to isolate GSCs by flow-cytometry cell sorting. Only PDOs characterized by histological and molecular conformity with primary tumors will be used. The mutational status of genes frequently associated with GBM onset and progression will be analyzed in PDOs, and compared with data derived from tumor DNA, in order to assess their representation of the genetic heterogeneity of original tumors. These studies will allow us the set up a reliable procedure for the ex-vivo establishment of pre-clinical models of GBM.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Evaluation of the effects of epigenetic and splicing inhibitors on viability and gene expression signatures of GBM PDOs and GSCs", "Type": "BIOLOGICAL", "Description": "PDOs and GSCs representing different GBM molecular subtypes will be treated with epigenetic modulators , with spliceosome inhibitors or with drugs that indirectly target the splicing machinery, such as PRMT5 inhibitors. These drugs will be tested for their ability to suppress growth and/or induce cell death, when administered either alone or in combination with standard chemotherapy. Furthermore, the investigators will perform RNA sequencing experiments to identify TE-derived transcripts and splice variants induced by the treatments. By employing a computational pipeline developed in our laboratory (Pieraccioli and Sette, unpublished), the investigators will also characterize the affinity for MHC-I and immunogenicity of neoepitopes encoded by the treatment-induced TE-derived transcripts and splice variants. The results of these analysis will allow to identify neoepitopes to be used for designing immunotherapy approaches.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [ "Epigenetic modifier" ] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Epigenetic modifier" ] } }, { "NCTId": "NCT00304031", "BriefTitle": "Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma", "OfficialTitle": "Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2006-01", "PrimaryCompletionDate": "2011-02", "Interventions": [ { "Name": "Concurrent temozolomide", "Type": "DRUG", "Description": "Daily oral temozolomide (75 mg/m2) up to 49 doses.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Concurrent radiation therapy", "Type": "RADIATION", "Description": "60 Gy in 2 Gy fractions", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle", "Type": "DRUG", "Description": "Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle", "Type": "DRUG", "Description": "Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)", "European Organisation for Research and Treatment of Cancer - EORTC", "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05410301", "BriefTitle": "Golden Halo, Static Magnetic and Electric Field Device, in Recurrent Glioblastoma", "OfficialTitle": "Feasibility Study of a Static Magnetic and Electric Field Device in Adults With Recurrent Glioblastoma and Their Partners", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2023-04", "PrimaryCompletionDate": "2026-08", "Interventions": [ { "Name": "Static Magnetic and Electric (sBE) device", "Type": "DEVICE", "Description": "Home-based Static Magnetic and Electric (sBE) device that is slept in", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Chemotherapy drug", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Chemotherapy and targeted therapy drug", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Varun Monga, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Iowa" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02658981", "BriefTitle": "Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18)", "OfficialTitle": "A Phase I Trial of Anti-LAG-3 or Anti-CD137 Alone and in Combination With Anti-PD-1 in Patients With Recurrent GBM", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-08-24", "PrimaryCompletionDate": "2022-04-30", "Interventions": [ { "Name": "Anti-LAG-3 Monoclonal Antibody BMS 986016", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Anti-PD-1", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "BMS-936558", "Nivolumab" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative Studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative Studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Anti-CD137", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "urelumab" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00052715", "BriefTitle": "Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial Of Poly-ICLC For Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2002-10-23", "PrimaryCompletionDate": "2006-02-25", "Interventions": [ { "Name": "poly ICLC", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04469699", "BriefTitle": "Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma", "OfficialTitle": "Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2021-04-12", "PrimaryCompletionDate": "2025-01-30", "Interventions": [ { "Name": "Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid", "Type": "DRUG", "Description": "5-ALA HCl orally (20 mg/kg bw) 3,5-4,5 hours prior to induction of anaesthesia for stereotactic biopsy followed by stereotactical photodynamic therapy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).", "OtherNames": [ "Gliolan, 5-aminolevulinic acid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic biopsy", "Type": "PROCEDURE", "Description": "Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital Muenster", "LeadSponsorClass": "OTHER", "Collaborators": [ "Deutsche Krebshilfe e.V., Bonn (Germany)", "photonamic GmbH & Co. KG", "medac GmbH", "LifePhotonic GmbH" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04826393", "BriefTitle": "ASP8374 + Cemiplimab in Recurrent Glioma", "OfficialTitle": "Phase Ib Trial of ASP8374 and Cemiplimab in Recurrent Malignant Glioma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-03-09", "PrimaryCompletionDate": "2022-10-31", "Interventions": [ { "Name": "ASP8374", "Type": "DRUG", "Description": "every 3 weeks by intravenous infusion", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cemiplimab", "Type": "DRUG", "Description": "intravenous infusion", "OtherNames": [ "Libtayo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Regeneron Pharmaceuticals", "Astellas Pharma Inc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04315584", "BriefTitle": "FDG and FDOPA PET Demonstration of Functional Brain Abnormalities", "OfficialTitle": "FDG and FDOPA PET Demonstration of Functional Brain Abnormalities", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-03-15", "PrimaryCompletionDate": "2023-12-20", "Interventions": [ { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT Scans", "OtherNames": [ "PET", "PET Scan", "Positron Emission Tomography Scan", "Medical Imaging, Positron Emission Tomography" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT Scans", "OtherNames": [ "CT", "CT Scan", "Computerized Axial Tomography", "CAT", "CAT scan" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Multiparametric Magnetic Resonance Imaging Scan", "Type": "PROCEDURE", "Description": "Undergo a multiparametric MRI scan", "OtherNames": [ "mpMRI", "multiparametric MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Fludeoxyglucose F-18", "Type": "RADIATION", "Description": "IV (intravenous) administration of radiotracer", "OtherNames": [ "FDG", "18 FDG", "fludeoxyglucose F 18", "2-F18-fluoro-2-deoxy-D-glucose", "2-F18-fluoro-2-deoxyglucose" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "fluorine F 18 fluorodopa", "Type": "RADIATION", "Description": "IV (intravenous) administration of radiotracer", "OtherNames": [ "18F-6- L-fluorodopa", "18F-DOPA", "18F-FDOPA", "3,4-dihydroxy-6-(18)F-fluoro-l-phenylalanine", "L-6-[ 18F]fluoro-3, 4-dihydroxyphenylalanine", "(18)F-FDOPA" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Virginia", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01156584", "BriefTitle": "A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-07", "PrimaryCompletionDate": "2016-08-18", "Interventions": [ { "Name": "Toca 511 vector", "Type": "BIOLOGICAL", "Description": "Single, stereotactic, transcranial, intratumoral injection or intravenous injection", "OtherNames": [ "Retroviral Replicating Vector (RRV)", "Gene Therapy", "Gene Transfer" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC", "Type": "DRUG", "Description": "4-6 week cycles of Toca FC. Doses evaluated from 120 mg/kg/day or 300 mg/kg/day. Duration of dosing evaluated: 6 days, 7 days or 14 days.", "OtherNames": [ "flucytosine, 5-FC, 5-FC XR, Toca FC (extended release flucytosine)" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02223052", "BriefTitle": "Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies", "OfficialTitle": "A Phase 1, Open-label, Multicenter, Randomized, 2-Period, Crossover Study to Evaluate the Bioequivalence and Food Effect Bioavailability of CC-486 (Oral Azacitidine) Tablets in Adult Cancer Subjects", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-10-27", "PrimaryCompletionDate": "2018-06-11", "Interventions": [ { "Name": "CC-486", "Type": "DRUG", "Description": "Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2", "OtherNames": [ "Oral Azacitdine" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Vidaza", "Type": "DRUG", "Description": "75mg/m\\^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles", "OtherNames": [ "Azacitidine for Injection", "AZA" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01872221", "BriefTitle": "Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study", "OfficialTitle": "Study of the Capacity of the MRI Spectroscopy to Define the Tumor Area Enriched in Glioblastoma Stem Cells. Proof of Concept Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2018-04", "Interventions": [ { "Name": "Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01403285", "BriefTitle": "Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma", "OfficialTitle": "A Phase 1 Trial of Peptide-Based Glioma Vaccine IMA950 in Patients With Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-08", "PrimaryCompletionDate": "2014-04", "Interventions": [ { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "One single low-dose i.v. infusion of cyclophosphamide (300mg/m2) prior to the first vaccination as pre-treatment", "OtherNames": [ "- Cytoxan (US name)", "- Endoxan (EU name)" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "IMA950 plus GM-CSF", "Type": "BIOLOGICAL", "Description": "Six vaccinations with IMA950 plus GM-CSF as adjuvant on 8 pre-defined days from Day 1 to Day 78", "OtherNames": [ "- Granulocyte macrophage-colony stimulating factor", "- Sargramostim", "- Leukine" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "IMA950", "Type": "BIOLOGICAL", "Description": "After Day 78, vaccinations with IMA950 (no GM-CSF) will be given on a monthly basis for up to one year from start of vaccination or until disease progression", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Imiquimod", "Type": "DRUG", "Description": "Imiquimod will be topically applied 10-20 minutes after each vaccination. After the third vaccination onward patients will apply additional imiquimod 24 hours after each vaccination at home on their own", "OtherNames": [ "- Aldara" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Immatics Biotechnologies GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00078988", "BriefTitle": "High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase III Randomized Trial for the Treatment of Pediatric High Grade Gliomas at First Recurrence With a Single High Dose Chemotherapy and Autologous Stem Cell Transplant Versus Three Courses of Intermediate Dose Chemotherapy With Peripheral Blood Stem Cell (PBSC) Support", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2004-10", "PrimaryCompletionDate": "2006-09", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Granulocyte Colony-Stimulating Factor", "r-metHuG-CSF", "G-CSF", "Neupogen", "NSC 614629" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Paraplain", "CBDCA", "NSC #241240" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "VP-16", "VePesid", "Etopophos", "NSC #141540" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "isotretinoin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "13-cis-retinoic acid", "RO-43", "780", "Accutane", "NSC#329481" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Tespa", "Thiophosphamide", "Triethylenethiophosphoramide Tspa", "WR-45312", "NSC#6396" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": "Peripheral blood stem cells or bone marrow will be reinfused about 72 hours following completion of the last dose of chemotherapy (Day 0)", "OtherNames": [ "Stem Cell Reinfusion" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": "Filgrastim is to be given daily in the afternoon for 4 days prior to the first harvest and continued until the completion of the daily harvests. The daily PBSC harvesting should be started prior to the fifth dose of filgrastim.", "OtherNames": [ "Peripheral Stem Cell Collection" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00063973", "BriefTitle": "Cilengitide in Treating Children With Refractory Primary Brain Tumors", "OfficialTitle": "Phase I Study of Cilengitide (EMD 121974) in Children With Refractory Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2003-07", "PrimaryCompletionDate": "2008-03", "Interventions": [ { "Name": "cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07284069", "BriefTitle": "Senicapoc and Perampanel for Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase 0/1 Randomized Clinical Trial of SENIcapoc and PERAmpanel Mono- and Combination Therapy of Newly Diagnosed Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2026-02-01", "PrimaryCompletionDate": "2028-11-01", "Interventions": [ { "Name": "senicapoc", "Type": "DRUG", "Description": "Senicapoc (ICA-17043) is a selective blocker of the intermediate-conductance calcium-activated potassium channel KCa3.1.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Perampanel", "Type": "DRUG", "Description": "Perampanel (Fycompa®) is a non-competitive AMPA-receptor antagonist approved for the treatment of focal and generalized tonic-clonic seizures.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Aarhus University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Aarhus", "University of Copenhagen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03452579", "BriefTitle": "Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in GBM", "OfficialTitle": "CA209-382 A Randomized Phase 2 Open Label Study of Nivolumab Plus Standard Dose Bevacizumab Versus Nivolumab Plus Low Dose Bevacizumab in Recurrent Glioblastoma (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-05-21", "PrimaryCompletionDate": "2020-12-30", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "240mg", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Standard Dose Bevacizumab", "Type": "DRUG", "Description": "10mg/kg", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Low Dose Bevacizumab", "Type": "DRUG", "Description": "3mg/kg", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "David Peereboom", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01246869", "BriefTitle": "Assessment of Primary and Metastatic Brain Tumor Hypoxia With Fluoromisonidazole, FDG and Water", "OfficialTitle": "Assessment of Primary and Metastatic Brain Tumor Hypoxia With 18F-Fluoromisonidazole, [18F]Fluoro-2-deoxy-D-glucose (FDG) and [15O]Water (H215O)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2013-03-27", "PrimaryCompletionDate": "2014-05-03", "Interventions": [ { "Name": "[18F]fluoro-2-deoxy-D-glucose (FDG)", "Type": "DRUG", "Description": "Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer", "OtherNames": [ "FDG", "[18F]FDG", "FDG-PET/CT" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "1H-1-(3-[18F]-fluoro-2-hydroxy-propyl)-2-nitro-imidazole [18F]-fluoromisonidazole", "Type": "DRUG", "Description": "Brain scan with radiopharmaceutical imaging tracer that directly assesses tumor hypoxia", "OtherNames": [ "[18F]FMISO", "FMISO", "FMISO-PET/CT" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "[15O]water", "Type": "DRUG", "Description": "Brain scan with imaging tracer used for measuring tumor blood flow/perfusion", "OtherNames": [ "H2[15O]", "H2[15O]-PET-CT" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "DIAGNOSTIC_TEST", "Description": "Brain scan to assess tumor size and tumor blood flow/perfusion", "OtherNames": [ "MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of Utah", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04450160", "BriefTitle": "Trial of AEO in New Glioblastoma (GBM)", "OfficialTitle": "A Phase 2, Randomized, Open-Label Study of Anhydrous Enol-Oxaloacetate in Subjects With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-12", "PrimaryCompletionDate": "2022-07", "Interventions": [ { "Name": "Anhydrous Enol-Oxaloacetate (AEO)", "Type": "DRUG", "Description": "Oral supplementation with AEO along with the Standard of Care (Temozolomide)", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard of Care", "Type": "OTHER", "Description": "Standard of Care Temozolomide", "OtherNames": [ "Chemotherapy with Temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "MetVital, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02323880", "BriefTitle": "Selinexor in Treating Younger Patients With Recurrent or Refractory Solid Tumors or High-Grade Gliomas", "OfficialTitle": "A Phase 1 Study of Selinexor (KPT-330), A Selective XPO1 Inhibitor, in Recurrent and Refractory Pediatric Solid Tumors, Including CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-10-30", "PrimaryCompletionDate": "2022-09-30", "Interventions": [ { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Selinexor", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ATG-010", "CRM1 Nuclear Export Inhibitor KPT-330", "KPT 330", "KPT-330", "KPT330", "Nexpovio", "Selective Inhibitor of Nuclear Export KPT-330", "SINE KPT-330", "Xpovio" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03899857", "BriefTitle": "Pembrolizumab for Newly Diagnosed Glioblastoma", "OfficialTitle": "Pembrolizumab for Newly Diagnosed Glioblastoma: a Prospective, Open-label, Single-arm, Multicenter Phase II Study", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-10-21", "PrimaryCompletionDate": "2026-04-30", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab will be added to standard of care", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT05023551", "BriefTitle": "Study of DSP-0390 in Patients With Recurrent High-Grade Glioma", "OfficialTitle": "A Phase 1 Study of DSP-0390 in Patients With Recurrent High-Grade Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-09-08", "PrimaryCompletionDate": "2026-09-30", "Interventions": [ { "Name": "DSP-0390", "Type": "DRUG", "Description": "DSP-0390 administered orally", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sumitomo Pharma America, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06455605", "BriefTitle": "D2C7-IT + 2141-V11 Combination Post-resection in rGBM", "OfficialTitle": "Clinical Trial of D2C7-IT + 2141-V11 Combination Immunotherapy Administered Via Convection Enhanced Delivery in Non-enhancing Tumor Post-resection of Recurrent Glioblastoma, Followed by Cervical Perilymphatic Subcutaneous Injections of 2141-V11", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-03-17", "PrimaryCompletionDate": "2029-01-31", "Interventions": [ { "Name": "D2C7-IT", "Type": "DRUG", "Description": "D2C7-IT will be dosed at 166,075 ng in 36 mL.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "2141 V11", "Type": "DRUG", "Description": "2141-V11 will be dosed at 3 mg in 3.5 mL for CED administration. 2141-V11 in the cervical perilymphatic subcutaneous area will be dosed at 2 mg.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rockefeller University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01957956", "BriefTitle": "Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2013-11-11", "PrimaryCompletionDate": "2016-11-16", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "Given ID", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02617745", "BriefTitle": "Impact of the Platelet Level in Patients Treated for Glioblastoma With Temozolomid", "OfficialTitle": "Impact of the Platelet Level During Radiotherapy Associated With Temozolomide in Patients Treated for Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-11-30", "PrimaryCompletionDate": "2022-11-28", "Interventions": [ { "Name": "Platelet level determination", "Type": "OTHER", "Description": "evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. For this the platelet level will be determined each wek during the radiotherapy phase and each cycle during the chemotherapy phase", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Henri Becquerel", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00540722", "BriefTitle": "Gossypol in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 2 Study of R-(-)-Gossypol (Ascenta's AT-101) in Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-01", "PrimaryCompletionDate": "2012-06", "Interventions": [ { "Name": "R-(-)-gossypol acetic acid", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AT-101" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05539339", "BriefTitle": "Personalized Trial in ctDNA-level-relapse Glioblastoma", "OfficialTitle": "Molecular Profiling of Tumor in Situ Fluid in Guiding Individualized Treatment Plan in Adults With ctDNA-level-relapse Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2022-12-01", "PrimaryCompletionDate": "2024-06-01", "Interventions": [ { "Name": "Individualized intervention based on genomic alterations", "Type": "OTHER", "Description": "Specialized tumor board recommended agents that target the specific recurrence-driving genomic alterations that are determined by serial TISF ctDNA analysis.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Henan Provincial People's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05917145", "BriefTitle": "ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Recurrent High-Grade Glioma", "OfficialTitle": "Phase 0/I Clinical Trial of the ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Recurrent High-Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-01-17", "PrimaryCompletionDate": "2028-02", "Interventions": [ { "Name": "WSD0628", "Type": "DRUG", "Description": "A non-toxic compound and inhibits the DNA damage response associated with radiation therapy. • WSD-0628 radio sensitizes Glioblastoma cells.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00091182", "BriefTitle": "Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment", "OfficialTitle": "A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-10", "PrimaryCompletionDate": "2006-02", "Interventions": [ { "Name": "oxaliplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "1-OHP", "Dacotin", "Dacplat", "Eloxatin", "L-OHP" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02903069", "BriefTitle": "Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer", "OfficialTitle": "Phase 1b, Multicenter, Open-Label Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-08-17", "PrimaryCompletionDate": "2021-01-25", "Interventions": [ { "Name": "MRZ", "Type": "DRUG", "Description": "MRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15, 29, and 36 during Concomitant Treatment.\n\nMRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15 every 28 days during Adjuvant Treatment.\n\nIV hydration will be given prior to the MRZ infusion.", "OtherNames": [ "NPI-0052" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TMZ", "Type": "DRUG", "Description": "TMZ will be administered once daily, 7 days/week, for 6 weeks, starting on Day 1, at a dose of 75 mg/m2 during Concomitant Treatment.\n\nTMZ will be administered once daily on Days 1-5 every cycle, dose range 150 to 200 mg/m2 during Adjuvant Treatment.", "OtherNames": [ "temozolomide", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "RT", "Type": "RADIATION", "Description": "Focal RT will be administered once daily, 5 days/week, for 30 doses over 6 weeks to a total dose of 60 Gy, starting on Day 1 during Concomitant Treatment.", "OtherNames": [ "radiation therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Optune", "Type": "DEVICE", "Description": "Tumor Treating Fields Therapy device to be worn ≥ 18 hours per day.", "OtherNames": [ "NovoTTF-100A" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Triphase Research and Development III Corp." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00085566", "BriefTitle": "Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer", "OfficialTitle": "A Phase I/II Trial to Assess the Tolerability of RAD 001 With Gefitinib in Patients With Glioblastoma Multiforme and Prostate Cancer and Efficacy in Patients With Castrate Metastatic Prostate Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2004-03", "PrimaryCompletionDate": "2008-02", "Interventions": [ { "Name": "everolimus", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "gefitinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02743078", "BriefTitle": "Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma", "OfficialTitle": "Phase II Trial Of Optune® Plus Bevacizumab In Bevacizumab-Refractory Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2017-05-09", "PrimaryCompletionDate": "2019-10-15", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "10 mg/kg every 2 weeks intravenously over 30 minutes.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "TTFields Therapy", "Type": "DEVICE", "Description": "Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks.", "OtherNames": [ "Optune", "Tumor Treating Fields Therapy", "TTF Therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "RTOG Foundation, Inc.", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02715297", "BriefTitle": "Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma", "OfficialTitle": "Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2016-02", "PrimaryCompletionDate": "2023-02", "Interventions": [ { "Name": "SRT to the resection cavity", "Type": "RADIATION", "Description": "46 Gy total dose will be delivered in 2 Gy per fraction, or 36 Gy delivered in 3 Gy per fraction, 5 fractions within 1 week. Doses will have to cover 95% of the PTV with the prescribed dose. The clinical target volume (CTV) will be defined as the resection cavity of the recurrent glioblastoma plus a margin of 5mm. A CTV to PTV margin of 1 to 3mm will be added according to technique used for immobilisation.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Technical University of Munich", "LeadSponsorClass": "OTHER", "Collaborators": [ "Helmholtz Zentrum München" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07356973", "BriefTitle": "Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma", "OfficialTitle": "Open-label Phase 2 Safety and Efficacy Trial of Irinotecan-ChemoSeed Administered Directly Into the Resection Margin in Patients With Surgically Resectable Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2026-03", "PrimaryCompletionDate": "2029-05", "Interventions": [ { "Name": "irinotecan-ChemoSeed implementation into the reserction cavity after surgical resection of GBM", "Type": "DRUG", "Description": "irinotecan-ChemoSeed implementation into the reserction cavity after surgical resection of GBM", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "CRISM Therapeutics LTD", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00039494", "BriefTitle": "Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors", "OfficialTitle": "A Pilot and Phase II Study of OSI-774 and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-12", "PrimaryCompletionDate": "2007-07", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CP-358,774", "erlotinib", "OSI-774" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "3-dimensional conformal radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "3D conformal radiation therapy", "3D-CRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT04776980", "BriefTitle": "Multimodality MRI and Liquid Biopsy in GBM", "OfficialTitle": "Multimodality MRI for Quantification of Tumor-associated Macrophages and Prediction of Somatic Mutation Detectability in Cell-free DNA in Adult Patients With Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-06", "PrimaryCompletionDate": "2022-06", "Interventions": [ { "Name": "Post Feraheme Infusion MRI", "Type": "DIAGNOSTIC_TEST", "Description": "All participants will receive a ferumoxtyol (Feraheme) infusion 20-28 hours prior to a head MRI. In addition, a blood draw for liquid biopsy targeted tissue sampling during surgery and special iron and macrophage staining on the tumor tissue.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01303835", "BriefTitle": "Low Dose Naltrexone for Glioma Patients", "OfficialTitle": "Effects of Low Dose Naltrexone on Quality of Life in High Grade Glioma Patients: A Placebo-Controlled, Double-Blind Randomized Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2014-06", "Interventions": [ { "Name": "LDN", "Type": "DRUG", "Description": "Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.", "OtherNames": [ "Low dose naltrexone", "ReVia" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Randomized patients received placebo to be taken every night before bed.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Katy Peters", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04119674", "BriefTitle": "Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Pilot Study of Anlotinib in Combination With STUPP Regimen for Treatment of Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-03-19", "PrimaryCompletionDate": "2022-08-23", "Interventions": [ { "Name": "Drug is Anlotinib.", "Type": "DRUG", "Description": "Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Drug is Temozolomide Capsule.", "Type": "DRUG", "Description": "Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiotherapy was initiated 4 to 6 weeks postoperatively.", "Type": "RADIATION", "Description": "Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Zhejiang Cancer Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00005790", "BriefTitle": "Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors", "OfficialTitle": "Perfusion Magnetic Resonance Imaging of Brain Tumors: Correlation With Indicators of Angiogenesis", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "1996-04", "PrimaryCompletionDate": "1999-05", "Interventions": [ { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "biopsy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "gadopentetate dimeglumine", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03246113", "BriefTitle": "Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma", "OfficialTitle": "Investigation of Cannabis For Tolerability and Feasibility in Patients Receiving Concurrent Chemoradiation for Glioblastoma.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-03-19", "PrimaryCompletionDate": "2019-05-09", "Interventions": [ { "Name": "Cannabis", "Type": "DRUG", "Description": "Cannabis cigarettes provided by NIDA that contain high levels of CBD (4.8%) and low levels of THC (3.23%). Patients will smoke one-half (1/2) to two (2) cannabis cigarettes prior to receiving chemoradiation.", "OtherNames": [ "Marijuana" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Oral alkylating agent with demonstrated antitumor activity.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "New York State Psychiatric Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06072586", "BriefTitle": "A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions", "OfficialTitle": "A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-10-18", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "BDTX-1535", "Type": "DRUG", "Description": "BDTX-1535 is an inhibitor of EGFR mutations", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "BDTX-1535 combined with radiation therapy", "Type": "DRUG", "Description": "During Phase 1, BDTX-1535 concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "BDTX-1535 combined with temozolomide and radiation therapy", "Type": "DRUG", "Description": "During Phase 1, BDTX-1535 concurrently with standard of care upfront RT and TMZ, followed by adjuvant BDTX-1535 combined with standard of care TMZ continuously in 28-day cycles after RT.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ivy Brain Tumor Center", "Barrow Neurological Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00575146", "BriefTitle": "Ketogenic Diet for Recurrent Glioblastoma", "OfficialTitle": "Ketogenic Diet for Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-12", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "TAVARLIN", "Type": "DIETARY_SUPPLEMENT", "Description": "ketogenic diet, dietary supplementary products provided by TAVARLIN", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital Tuebingen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Evomed MedizinService GmbH" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00679354", "BriefTitle": "Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy", "OfficialTitle": "Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-06", "PrimaryCompletionDate": "2010-10", "Interventions": [ { "Name": "cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00761280", "BriefTitle": "Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma", "OfficialTitle": "Efficacy and Safety of AP 12009 in Adult Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma as Compared to Standard Chemotherapy Treatment: A Randomized, Actively Controlled, Open Label Clinical Phase III Study.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2008-12", "PrimaryCompletionDate": "2012-02", "Interventions": [ { "Name": "trabedersen", "Type": "DRUG", "Description": null, "OtherNames": [ "AP 12009" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar", "Temodal", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Drug delivery system for administration of AP 12009", "Type": "DEVICE", "Description": "Drug delivery system for Convection Enhanced Delivery consists of a portable pump (Pegasus vario or Pega vario) with drug reservoir (Pega Bag) and infusion line (Pega Line). Main implanted parts are the port access system (PORT-A-CATH) and the intratumoral catheter (Medtronic ventricular catheter).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placement of Drug Delivery System", "Type": "PROCEDURE", "Description": "Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [ "BCNU", "BiCNU", "Carmubris" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "lomustine", "Type": "DRUG", "Description": null, "OtherNames": [ "CCNU", "CeeNU" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Isarna Therapeutics GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01466686", "BriefTitle": "Low Dose Radiation Therapy for Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-Potentiator of Salvage Temozolomide for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-09", "PrimaryCompletionDate": "2021-12", "Interventions": [ { "Name": "Low Dose Fractionated Radiation Therapy (LDFRT)", "Type": "RADIATION", "Description": "All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If \\> 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00006386", "BriefTitle": "Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-03", "PrimaryCompletionDate": "2004-11", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "stereotactic radiosurgery", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05772741", "BriefTitle": "Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs", "OfficialTitle": "Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2018-12-03", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Biological sample collection", "Type": "OTHER", "Description": "Collection of biological samples", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [ "Catholic University of the Sacred Heart", "Istituto Superiore di Sanità", "Heinrich-Heine University, Duesseldorf" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01894061", "BriefTitle": "NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Prospective Phase II Trial of NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-09-18", "PrimaryCompletionDate": "2019-07-01", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.", "OtherNames": [ "Avastin", "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "anti-VEGF rhuMAb", "recombinant humanized anti-VEGF monoclonal antibody", "rhuMAb VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "NovoTTF-l00A", "Type": "DEVICE", "Description": "NovoTTF-100A will be worn continuously.", "OtherNames": [ "electric field therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Quality of Life Assessment", "Type": "OTHER", "Description": "Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire", "OtherNames": [ "FACT-Br questionnaire" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02623231", "BriefTitle": "The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients", "OfficialTitle": "The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2015-12", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Escitalopram", "Type": "DRUG", "Description": "Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months", "OtherNames": [ "Cipralex" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "placebo", "Type": "DRUG", "Description": "group # 2 Will include 50 patients , who will receive placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tel-Aviv Sourasky Medical Center", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02521090", "BriefTitle": "EGFRBi-Armed Autologous T Cells in Treating Patients With Recurrent or Refractory Glioblastoma", "OfficialTitle": "Targeting Recurrent Glioblastoma With Anti-CD3 x Anti-EGFR Bispecific Antibody Armed T Cells: A Phase I/II Study", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-08", "PrimaryCompletionDate": "2016-03", "Interventions": [ { "Name": "EGFRBi-Armed Autologous T Cells", "Type": "BIOLOGICAL", "Description": "Given IT and IV", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Barbara Ann Karmanos Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00634231", "BriefTitle": "A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors", "OfficialTitle": "A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "AdV-tk", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "valacyclovir", "Type": "DRUG", "Description": null, "OtherNames": [ "Prodrug" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": null, "OtherNames": [ "Radiation therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Candel Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Boston Children's Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03687034", "BriefTitle": "A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma", "OfficialTitle": "A Phase I Study of BRCX014 to Investigate Dose-Ranging Safety and Pharmacokinetics in Adults With Glioblastoma (GBM) and Non-Methylated MGMT Gene Status", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2019-06-01", "PrimaryCompletionDate": "2019-09-30", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Standard-of-care chemotherapy for patients with glioblastoma includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body- surface area per day, seven days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle).", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Optune", "Type": "DEVICE", "Description": "Standard-of-care treatment for glioblastoma includes alternating electric-field therapy, or Optune, as a Category 1 treatment in conjunction with temozolomide after maximal safe resection and completion of radiation therapy.", "OtherNames": [ "TTFields" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Leaf Vertical Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02844439", "BriefTitle": "Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 2, Multicenter Study of Tesevatinib Monotherapy in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-06", "PrimaryCompletionDate": "2020-04-30", "Interventions": [ { "Name": "Tesevatinib", "Type": "DRUG", "Description": null, "OtherNames": [ "KD019, XL647" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Kadmon Corporation, LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04015700", "BriefTitle": "Neoantigen-based Personalized DNA Vaccine in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OfficialTitle": "A Pilot Study to Assess the Safety, Feasibility, and Immunogenicity of a Neoantigen-based Personalized in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-07-14", "PrimaryCompletionDate": "2022-05-13", "Interventions": [ { "Name": "Personalized neoantigen DNA vaccine supplied by Geneos Therapeutics", "Type": "BIOLOGICAL", "Description": "-The neoantigen DNA vaccines are also known as DNA plasmid vector expressing tumor-specific antigens.", "OtherNames": [ "GNOS-PV01", "Vaccine" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "CELLECTRA®2000 EP Device supplied by Geneos Therapeutics", "Type": "DEVICE", "Description": "CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Plasmid encoded IL-12", "Type": "DRUG", "Description": "The INO-9012 vials will be supplied by Geneos Therapeutics", "OtherNames": [ "INO-9012" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Geneos Therapeutics", "The Foundation for Barnes-Jewish Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05739942", "BriefTitle": "Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma", "OfficialTitle": "Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma and as a Single Agent in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-05-15", "PrimaryCompletionDate": "2026-12-10", "Interventions": [ { "Name": "[177Lu]Lu-NeoB", "Type": "DRUG", "Description": "Radiopharmaceutical solution for infusion", "OtherNames": [ "Lu-NeoB" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "[68Ga]Ga-NeoB", "Type": "DRUG", "Description": "Either provided as Kit for the radiopharmaceutical preparation of \\[68Ga\\]Ga-NeoB or as ready to use radiopharmaceutical solution for injection", "OtherNames": [ "Ga-NeoB" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "OTHER", "Description": "Capsules/ lyophilized powder in single-dose vial for reconstitution.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03170141", "BriefTitle": "Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme", "OfficialTitle": "Immunogene-modified Antigen-specific T (IgT) Cells for the Treatment of Glioblastoma Multiforme", "OverallStatus": "ENROLLING_BY_INVITATION", "Phase": [ "PHASE1" ], "StartDate": "2017-05-31", "PrimaryCompletionDate": "2027-07-31", "Interventions": [ { "Name": "Antigen-specific IgT cells", "Type": "BIOLOGICAL", "Description": "Tumor antigen-specific IgT cells are infused intravenously . Drug: cyclophosphamide 250 mg/m\\^2 d1-3; Drug: Fludarabine 25mg/m\\^2 d1-3", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shenzhen Geno-Immune Medical Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00243022", "BriefTitle": "Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme", "OfficialTitle": "Phase II Randomized Evaluation of 5-Lipoxygenase Inhibition by Herbal Complementary and Alternative Medicine Approach Compared to Control as an Adjuvant Therapy in Newly Diagnosed and Recurrent High-grade Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2004-09", "PrimaryCompletionDate": "2010-03", "Interventions": [ { "Name": "Boswellia serrata extract", "Type": "DRUG", "Description": "given orally", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyanocobalamin", "Type": "DIETARY_SUPPLEMENT", "Description": "given orally", "OtherNames": [ "Vitamin B12" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ali Altunkaya", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03151772", "BriefTitle": "Bioavailability of Disulfiram and Metformin in Glioblastomas", "OfficialTitle": "Drug Level and Investigation of Novel Substances Indicated Downstream Effect in Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2018-01-29", "PrimaryCompletionDate": "2020-09-24", "Interventions": [ { "Name": "Disulfiram", "Type": "DRUG", "Description": "200 mg disulfiram two times daily and 2,5 mg copper once daily taken preoperatively", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Metformin", "Type": "DRUG", "Description": "Metformin 850 mg x 3 taken preoperatively", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sahlgrenska University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00004200", "BriefTitle": "Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Randomized Double-Blind, Placebo-Controlled Phase II Study of the Matrix Metalloprotease Inhibitor Prinomastat in Combination With Temozolomide Following Radiation Therapy in Patients Having Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-10", "PrimaryCompletionDate": "2002-01", "Interventions": [ { "Name": "prinomastat", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Pfizer", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06989086", "BriefTitle": "FearLess in NeuroOncology", "OfficialTitle": "FearLess in Neuro-Oncology", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-06-24", "PrimaryCompletionDate": "2028-12-31", "Interventions": [ { "Name": "Fearless in Neuro-Oncology", "Type": "BEHAVIORAL", "Description": "FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Virginia Commonwealth University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "National Brain Tumor Society" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03705351", "BriefTitle": "Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM", "OfficialTitle": "Safety and Tolerability of Tumor Treating Fields (TTFields) Combined With Chemoradiation in Newly Diagnosed Glioblastoma (Unity)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2019-12-02", "PrimaryCompletionDate": "2021-02-24", "Interventions": [ { "Name": "Tumor Treating Fields", "Type": "DEVICE", "Description": "Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.", "OtherNames": [ "Optune", "Novocure" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients will be given temozolomide according to routine treatment dosing and schedule.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Patients will be given radiation therapy according to routine treatment dosing and schedule.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Providence Health & Services", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of California, San Francisco", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04474353", "BriefTitle": "Study of Tumor Treating Fields With Hypofractionated Chemoradiotherapy in Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 1 Study of Tumor Treating Fields With 5 Day Hypofractionated Stereotactic Radiosurgery and Concurrent and Maintenance Temozolomide in Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2021-05-21", "PrimaryCompletionDate": "2024-11-14", "Interventions": [ { "Name": "Optune", "Type": "DEVICE", "Description": "Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Gadolinium", "Type": "DRUG", "Description": "Gadolinium contrast medium", "OtherNames": [ "Contrast agent" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Chemotherapy agent", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Stereotactic radiosurgery (SRS)", "Type": "RADIATION", "Description": "Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05235737", "BriefTitle": "The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab", "OfficialTitle": "A Single Center, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of Neoadjuvant and Adjuvant Pembrolizumab on Top of Standard Chemo-Radiotherapy (Stupp Protocol) in Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme (GBM).", "OverallStatus": "RECRUITING", "Phase": [ "PHASE4" ], "StartDate": "2022-03-01", "PrimaryCompletionDate": "2025-06-01", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Adding Pembrolizumab as a neoadjuvant and adjuvant therapy to the standard of care protocol", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Adding Pembrolizumab as a neoadjuvant therapy to the standard of care protocol", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Medical University of Silesia", "LeadSponsorClass": "OTHER", "Collaborators": [ "Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT01120639", "BriefTitle": "Phase 1-2 of Temozolomide and Hypofractionated Radiotherapy in Tx of Supratentorial Glioblastoma Multiform", "OfficialTitle": "A Phase 1-2 Trial of Temozolomide and Hypofractionated Radiotherapy in Treatment of Supratentorial Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2016-11", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.", "OtherNames": [ "Temodar", "Temodal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Stereotactic Radiosurgery (SRS)", "Type": "PROCEDURE", "Description": "Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)", "OtherNames": [ "Hypofractionated stereotactic radiosurgery (h-SRS)", "Hypofractionated stereotactic radiotherapy", "Cyberknife surgery" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04266977", "BriefTitle": "Restrictive Use of Dexamethasone in Glioblastoma", "OfficialTitle": "Restrictive Use of Dexamethasone in Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-05-08", "PrimaryCompletionDate": "2027-04", "Interventions": [ { "Name": "Dexamethasone", "Type": "DRUG", "Description": "restrictive use of DEX, based on standardized clinical and radiological criteria.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Insel Gruppe AG, University Hospital Bern", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06389591", "BriefTitle": "RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)", "OfficialTitle": "A Phase I Study of RNA-Lipid Particle (RNA-LP) Vaccines for Recurrent Adult Glioblastoma (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-12-02", "PrimaryCompletionDate": "2026-12-01", "Interventions": [ { "Name": "pp65 RNA loaded lipid particles, pp65 RNA-LPs (Drug Product 1 or DP1)", "Type": "BIOLOGICAL", "Description": "pp65 RNA loaded lipid particles or pp65 RNA-LPs administered intravenously", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "RNA loaded lipid particles, RNA-LPs (Drug Product 2 or DP2)", "Type": "BIOLOGICAL", "Description": "personalized tumor mRNA, pp65 fl LAMP mRNA and DOTAP liposomes or RNA loaded lipid particles, RNA-LPs administered intravenously", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01004874", "BriefTitle": "Avastin/Radiation (XRT)/Temozolomide (Temodar) Followed by Avastin/Temodar/Topotecan for Glioblastoma", "OfficialTitle": "Avastin in Combination With Radiation and Temozolomide Followed by Avastin, Temozolomide, and Topotecan for Glioblastoma Multiformes and Gliosarcomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-12-30", "PrimaryCompletionDate": "2012-07", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab (Avastin) at 10 mg/kg every other week during standard radiation therapy (XRT). Following XRT, bevacizumab will remain at 10 mg/kg every other week.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation therapy (XRT). Following XRT, temozolomide will be dosed at 150 mg/m2 daily the first 5 days of each 28-day cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Radiation Therapy (XRT)", "Type": "RADIATION", "Description": "Standard radiation therapy for approximately 6.5 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Topotecan", "Type": "DRUG", "Description": "Following standard radiation therapy, patients will receive topotecan on days 2 through 6 of each 28-day cycle at a dose of 1.5 mg/m2 for patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs) and 2.0 mg/m2 for patients taking EIAEDs.", "OtherNames": [ "Hycamtin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03475186", "BriefTitle": "Testing Ramipril to Prevent Memory Loss in People With Glioblastoma", "OfficialTitle": "A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2019-03-25", "PrimaryCompletionDate": "2025-03-25", "Interventions": [ { "Name": "Ramipril", "Type": "DRUG", "Description": "2.5 - 5 mg oral, 1x daily for 22 weeks", "OtherNames": [ "Altace", "Tritace" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04280848", "BriefTitle": "Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma", "OfficialTitle": "Anticancer Therapeutic Vaccination Using Telomerase-derived Universal Cancer Peptides in Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-05-26", "PrimaryCompletionDate": "2023-12-21", "Interventions": [ { "Name": "UCPVax", "Type": "DRUG", "Description": "The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ).\n\nUCPVax vaccine will injected subcutaneously at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination one month after the last injection and then every 8 weeks for 12 months maximum.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "TERT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "6 additional monthly cures of Temozolomide (after concomitant radiotherapy and temozolomide) according to standard of care", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "TERT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire de Besancon", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "TERT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05432518", "BriefTitle": "Pilot Trial for Treatment of Recurrent Glioblastoma", "OfficialTitle": "Biomarker and Tumor Cell Culture-Driven Pilot Trial for Treatment of Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-06-27", "PrimaryCompletionDate": "2027-07-01", "Interventions": [ { "Name": "Afatinib", "Type": "DRUG", "Description": "Afatinib will be administered orally at a dose of 40 mg daily in patients with EGFR amplification.", "OtherNames": [ "Giotrif" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Dasatinib", "Type": "DRUG", "Description": "Dasatinib will be administered orally at a dose of 100 mg once daily in patients with PDGFR amplification.", "OtherNames": [ "Sprycel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Palbociclib", "Type": "DRUG", "Description": "Palbociclib will be administered orally at a dose of 125 mg once daily in patients with CDK4 and CDK6 amplification.", "OtherNames": [ "Ibrance" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "Everolimus will be administered orally at a dose of 10 mg daily in patients with PI3K/PTEN/mTOR activated pathways.", "OtherNames": [ "Teva-everolimus" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PI3K", "mTOR" ], "classes": [] } }, { "Name": "Olaparib", "Type": "DRUG", "Description": "Olaparib will be administered orally at a dose of 300 mg twice daily in patients with TP53 mutation.", "OtherNames": [ "Lynparza" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [ "Tom Baker Cancer Centre" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "EGFR", "PARP", "PI3K", "mTOR" ], "classes": [ "Cell cycle inhibitor", "DNA repair inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT00066248", "BriefTitle": "Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment", "OfficialTitle": "The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-06", "PrimaryCompletionDate": "2007-08", "Interventions": [ { "Name": "cyproheptadine hydrochloride", "Type": "DRUG", "Description": "Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.", "OtherNames": [ "Periactin" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "megestrol acetate", "Type": "DRUG", "Description": "Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.", "OtherNames": [ "Megace" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of South Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02296476", "BriefTitle": "A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)", "OfficialTitle": "A Phase IIa Trial With Dose Optimization of OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-terminal (BET) Proteins, in Recurrent Glioblastoma Multiforme (GBM) Patients", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-10-29", "PrimaryCompletionDate": "2015-10-20", "Interventions": [ { "Name": "Birabresib", "Type": "DRUG", "Description": "Administered orally in a fasted state once daily.", "OtherNames": [ "OTX015", "MK-8628" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01115491", "BriefTitle": "A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-06", "PrimaryCompletionDate": "2012-07", "Interventions": [ { "Name": "bevacizumab [Avastin]", "Type": "DRUG", "Description": "Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01240460", "BriefTitle": "Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection", "OfficialTitle": "An Exploratory Pharmacodynamic Study of XL765 and XL147 Administered as Single Agents to Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-01", "PrimaryCompletionDate": "2012-06", "Interventions": [ { "Name": "XL765 (SAR245409)", "Type": "DRUG", "Description": "Supplied as 10-mg and/or 50-mg capsules", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "XL147 (SAR245408)", "Type": "DRUG", "Description": "Supplied as 100-mg, 150-mg and/or 200-mg tablets", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sanofi", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00302159", "BriefTitle": "Valproic Acid With Temozolomide and Radiation Therapy to Treat Brain Tumors", "OfficialTitle": "A Phase II Clinical Trial of the Histone Deacetylase Inhibitor Valproic Acid in Combination With Temodar and Radiation Therapy in Patients With High Grade Gliomas: Multi-Institutional Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-03", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Orally 75mg/m\\^2 first day of radiation until completion. Restart 4 weeks post radiation.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "Name": "Valproic Acid", "Type": "DRUG", "Description": "Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.", "OtherNames": [ "Depakote" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Epigenetic modifier" ] } }, { "NCTId": "NCT02177578", "BriefTitle": "Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme", "OfficialTitle": "A Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2014-07-08", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients will be scheduled to receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Subventricular Zone radiation", "Type": "RADIATION", "Description": "Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:\n\nInitial treatment plan:\n\nWill be prescribed to 46 Gy in 2 Gy fractions\n\nCone down treatment plan:\n\nWill be prescribed to 14 Gy in 2 Gy fractions", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Neural Progenitor Cell Sparing radiation", "Type": "RADIATION", "Description": "Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:\n\nInitial treatment plan:\n\nWill be prescribed to 46 Gy in 2 Gy fractions\n\nCone down treatment plan:\n\nWill be prescribed to 14 Gy in 2 Gy fractions", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Reading Health System Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00753246", "BriefTitle": "Nimotuzumab in Adults With Glioblastoma Multiforma", "OfficialTitle": "Phase-III Study of Standard Radiotherapy Plus Concomitant and Adjuvant OSAG 101 (Theraloc®) Plus Temozolomide vs. Standard Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Patient With Newly Diagnosed, Histologically Confirmed Glioblastoma Multiforme Grade IV", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2007-08", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "nimotuzumab", "Type": "DRUG", "Description": "monoclonal antibody", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Oncoscience AG", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Neurological Clinic, Knappschaftskrankenhaus Bochum-Langendreer, Bochum, Germany", "University of Bonn", "Dep. of Neurosurgery and Policlinic, University Hospital, Dresden, Germany", "Heinrich-Heine University, Duesseldorf", "Johann Wolfgang Goethe University Hospital", "University of Giessen", "Universitätsklinikum Hamburg-Eppendorf", "University of Kiel", "Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany", "Universität Tübingen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04536649", "BriefTitle": "Proton and Heavy Ion Beam Radiation vs. Photon Beam Radiation for Newly Diagnosed Glioblastoma.", "OfficialTitle": "Proton and Heavy Ion Beam Radiation Versus Photon Beam Radiation for Newly Diagnosed Glioblastoma: A Multi-center Prospective Phase 3 Randomized Control Clinical Trial.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2020-10-01", "PrimaryCompletionDate": "2023-09-30", "Interventions": [ { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Multimodal brain imaging-guided radiotherapy using different beams", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shanghai Proton and Heavy Ion Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "RenJi Hospital", "Ruijin Hospital", "Fudan University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06946680", "BriefTitle": "IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Pediatric High-grade Glioma (HGG)", "OfficialTitle": "Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in CD70+ Adult GBM and Pediatric High-Grade Gliomas (pHGG)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-03-18", "PrimaryCompletionDate": "2030-12", "Interventions": [ { "Name": "Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells", "Type": "BIOLOGICAL", "Description": "Single dose of 8R-70CAR T cells administered IV", "OtherNames": [ "8R-70CAR T cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Florida Department of Health, Live Like Bella", "St. Baldrick's Foundation", "American Brain Tumor Association" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04482933", "BriefTitle": "HSV G207 With a Single Radiation Dose in Children With Recurrent High-Grade Glioma", "OfficialTitle": "Phase II Clinical Trial of HSV G207 With a Single 5 Gy Radiation Dose in Children With Recurrent High-Grade Glioma", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE2" ], "StartDate": "2025-09-01", "PrimaryCompletionDate": "2029-12-16", "Interventions": [ { "Name": "Biological G207", "Type": "BIOLOGICAL", "Description": "Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI", "OtherNames": [ "Experimental: HSV G207" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Treovir, LLC", "National Cancer Institute (NCI)", "American Lebanese Syrian Associated Charities" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006268", "BriefTitle": "Immunotoxin Therapy in Treating Patients With Malignant Glioma", "OfficialTitle": "Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-10", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "cintredekin besudotox", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "isolated perfusion", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03491683", "BriefTitle": "INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM)", "OfficialTitle": "An Open-Label, Multi-Center Trial of INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With REGN2810 in Subjects With Newly-Diagnosed Glioblastoma (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-05-31", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "INO-5401", "Type": "BIOLOGICAL", "Description": "INO-5401 is a combination of 3 separate DNA plasmids targeting Wilms tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) genes. Starting on Day 0 three milligrams (mg) of each plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by immunotherapy Response Assessment in Neuro-Oncology (iRANO), unacceptable toxicity, withdrawal of consent, or death.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "TERT" ], "classes": [] } }, { "Name": "INO-9012", "Type": "BIOLOGICAL", "Description": "INO-9012 is a DNA plasmid for expression of human interleukin-12 (IL-12). Starting on Day 0 one mg plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cemiplimab", "Type": "BIOLOGICAL", "Description": "Cemiplimab is an antibody to programmed death-1 (PD-1) protein. Starting on Day 0 cemiplimab will be administered intravenously (IV) every three weeks at a dose of 350 mg per dose in the absence of dose holding, until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.", "OtherNames": [ "REGN2810" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiation therapy (RT) will begin no later than 42 days after surgical intervention, and should start approximately 2 weeks after Day 0. RT will be given for three weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m\\^2).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Inovio Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "PD-1", "TERT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00350727", "BriefTitle": "Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma", "OfficialTitle": "Phase I and II, Open-Label, Multi-Center Trials of Pazopanib in Combination With Lapatinib in Adult Patients With Relapsed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-12", "PrimaryCompletionDate": "2009-12", "Interventions": [ { "Name": "pazopanib", "Type": "DRUG", "Description": "Pazopanib is a novel compound being developed for the treatment of various cancers.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "lapatinib", "Type": "DRUG", "Description": "Lapatinib is a novel compound being developed for the treatment of various cancers.", "OtherNames": [ "pazopanib" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "GlaxoSmithKline", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03626896", "BriefTitle": "Safety of BBB Disruption Using NaviFUS System in Recurrent Glioblastoma Multiforme (GBM) Patients", "OfficialTitle": "A FIH Feasibility Study to Evaluate the Safety of Transient Disruption of Blood-brain Barrier in Recurrent Glioblastoma Multiforme (GBM) Patients Using NaviFUS System", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2018-08-17", "PrimaryCompletionDate": "2019-05-20", "Interventions": [ { "Name": "NaviFUS System", "Type": "DEVICE", "Description": "BBB Disruption by FUS in recurrent GBM Other Name: Neuronavigation-guided focus ultrasound system", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NaviFUS Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Chang Gung Memorial Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00990496", "BriefTitle": "A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase I-II Study of Allogeneic CMV Specific Cytotoxic T Lymphocytes (CTL) for Patients With Refractory Glioblastoma Multiforme (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2010-10-28", "Interventions": [ { "Name": "Fludarabine", "Type": "DRUG", "Description": "30 mg/m2", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "600 mg/m2", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CMV Specific Cytotoxic T Lymphocytes (CTL)", "Type": "BIOLOGICAL", "Description": "CTL Infusion (3 - 5 x 10E6 cells/kg)", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Milton S. Hershey Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00499473", "BriefTitle": "Sunitinib in Treating Patients With Recurrent Malignant Gliomas", "OfficialTitle": "A Pharmacokinetic and Phase 2 Study of Sunitinib Malate in Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-06", "PrimaryCompletionDate": "2009-06", "Interventions": [ { "Name": "sunitinib malate", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "SU11248", "sunitinib", "Sutent" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01151670", "BriefTitle": "Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors", "OfficialTitle": "Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2014-08", "Interventions": [ { "Name": "pioglitazone", "Type": "DRUG", "Description": "Pioglitazone 22.5 mg daily before, during and after radiation therapy.", "OtherNames": [ "Actos" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pioglitazone", "Type": "DRUG", "Description": "Pioglitazone 45 mg by mouth daily before, during and after radiation therapy", "OtherNames": [ "Actos" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03033524", "BriefTitle": "Trial to Evaluate the Safety of TTAC-0001(Tanibirumab) in Recurrent Glioblastoma", "OfficialTitle": "A Multicenter, 3-Arm, Open-Label, Phase Ⅱa Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-02-04", "PrimaryCompletionDate": "2017-06-02", "Interventions": [ { "Name": "TTAC-0001", "Type": "DRUG", "Description": "Calculated amount of drug will be diluted with normal saline and administered intravenously.", "OtherNames": [ "Tanibirumab" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "PharmAbcine", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02285959", "BriefTitle": "Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme", "OfficialTitle": "Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2014-06", "PrimaryCompletionDate": "2025-06", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Global Neurosciences Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03551249", "BriefTitle": "Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption", "OfficialTitle": "Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-03-26", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Focused ultrasound (FUS)", "Type": "DEVICE", "Description": "FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.", "OtherNames": [ "ExAblate, Type 2" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00005855", "BriefTitle": "Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma", "OfficialTitle": "A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "efaproxiral", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05271240", "BriefTitle": "Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM", "OfficialTitle": "A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2022-04-27", "PrimaryCompletionDate": "2027-04-01", "Interventions": [ { "Name": "Repeated Superselective Intraarterial Cerebral infusion (SIACI) of Bevacizumab (Avastin) with Temozolomide and Radiation", "Type": "DRUG", "Description": "Subjects who are assigned to the IA BV+TMZ/RT group (Treatment Group), in addition to your standard of care cancer treatment, you will have a dose of bevacizumab delivered directly to your brain through superselective intra-cranial intra-arterial catheterization of the arteries that supply blood to your brain tumor along with the start of the initial 42 day oral temozolomide treatment. IA BV will be repeated every three months for a total of 3 infusions.", "OtherNames": [ "IA BV+TMZ/RT", "Intraarterial Bevacizumab" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide and Radiation Alone", "Type": "DRUG", "Description": "Subjects who are assigned to the TMZ/RT alone group (Control Group) you will receive standard of care cancer treatment that involves a daily oral dose of temozolomide for 42 days with radiation to the tumor followed by 28 days of rest and then repeated maintenance treatment cycles of daily oral temozolomide 5 days on and 23 days off.", "OtherNames": [ "TMZ/RT alone" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00763750", "BriefTitle": "PPX, Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors", "OfficialTitle": "BrUOG-Brain-223-A Phase II Study of PPX (CT-2103), Temozolomide, and Concurrent Radiation for Newly Diagnosed Brain Tumors (CTI # CT2103) Principal Investigator: Howard Safran, M.D.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-10", "PrimaryCompletionDate": "2011-06", "Interventions": [ { "Name": "PPX +TMZ+XRT", "Type": "DRUG", "Description": "PPX 50 mg/m2/week x 6 weeks (Days #1, 8, 15, 22, 29, 36) XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide 75 mg/m2/day: Day #1 of XRT until completion (including weekends and holidays)", "OtherNames": [ "PPX TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "howard safran", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rhode Island Hospital", "MaineHealth" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01954576", "BriefTitle": "NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study of the Optune System, Enhanced by Genomic Analysis to Identify the Genetic Signature of Response in the Treatment of Recurrent Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2013-10-10", "PrimaryCompletionDate": "2021-05-14", "Interventions": [ { "Name": "NovoTTF-100A", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-life assessment", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory biomarker analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Washington University School of Medicine", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06186440", "BriefTitle": "Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma", "OfficialTitle": "Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With Newly Diagnosed MGMT Promotor Unmethylated Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-01-01", "PrimaryCompletionDate": "2024-12-01", "Interventions": [ { "Name": "Cisplatin Plus Temozolomide", "Type": "DRUG", "Description": "Cisplatin Plus Temozolomide . Cisplatin 20mg/mCisplatin days 1-5", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Zhongnan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02768389", "BriefTitle": "Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma", "OfficialTitle": "A Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2016-09-06", "PrimaryCompletionDate": "2018-11", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Subjects receive Bevacizumab as standard of care", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "Modified Atkins Diet", "Type": "BEHAVIORAL", "Description": "The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\\< 20gm/day).", "OtherNames": [ "MAD" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Cincinnati", "OhioHealth Research Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT02750891", "BriefTitle": "A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas", "OfficialTitle": "A Phase 1/2 Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-04", "PrimaryCompletionDate": "2020-01", "Interventions": [ { "Name": "DSP-7888", "Type": "DRUG", "Description": "Phase1 portion: 1.75 or 3.5 mg/body, Id every 1-4 weeks Phase 2 portion: recommended phase 2 dose, Id every 1-4 weeks", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sumitomo Pharma Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00968240", "BriefTitle": "Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)", "OfficialTitle": "Phase I Trial of Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab) For Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-07", "PrimaryCompletionDate": "2014-01", "Interventions": [ { "Name": "Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB", "Type": "DRUG", "Description": "This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival of patients with relapsed/refractory GBM/AA.\n\nDay 0: Intraarterial Avastin single dose (starting at 2mg/kg and up to 10mg/kg) after Mannitol to open the blood brain barrier.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02631655", "BriefTitle": "POSitron Emission Imaging Using 18F-FDOPA in Neurooncology", "OfficialTitle": "Study of the Impact of 18F-FDOPA Positon Emission Tomography on Therapeutic Proposals Made at Neurooncology Multidisciplinary Case Conferences", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2015-12", "PrimaryCompletionDate": "2020-06", "Interventions": [ { "Name": "impact of device 18F-FDOPA PET on treatment decisions", "Type": "OTHER", "Description": "Imagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Antoine Lacassagne", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00128635", "BriefTitle": "Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme", "OfficialTitle": "An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131 I-chTNT-1/B MAb (COTARA(TM)) For the Treatment of Glioblastoma Multiforme (GBM) at 1st or 2nd Relapse", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-10", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "iodine I 131 monoclonal antibody TNT-1/B", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01233492", "BriefTitle": "Boron Phenylalanine With or Without Mannitol in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "A Cancer Research UK Pharmacokinetic Study of BPA in Patients With High Grade Glioma to Optimize Uptake Parameters for Clinical Trials of BNCT", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2013-09", "Interventions": [ { "Name": "boron phenylalanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "mannitol", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "biologic sample preservation procedure", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "radiation therapy treatment planning/simulation", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Cancer Research UK", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05941507", "BriefTitle": "A Study to Evaluate TROP2 ADC LCB84 Single Agent and in Combination With an Anti-PD-1 Ab in Advanced Solid Tumors", "OfficialTitle": "A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of TROP2-Directed Antibody-Drug Conjugate LCB84, as a Single Agent and in Combination With an Anti-PD-1 Ab, in Patients With Advanced Solid Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-10-05", "PrimaryCompletionDate": "2027-01", "Interventions": [ { "Name": "LCB84", "Type": "DRUG", "Description": "TROP2-directed human monoclonal antibody (Ab) linked to a monomethyl auristatin E (MMAE) prodrug", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Anti-PD-1 monoclonal antibody", "Type": "DRUG", "Description": "anti-PD-1 Ab", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "LigaChem Biosciences, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "AntibodyChem Biosciences, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT05163080", "BriefTitle": "SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)", "OfficialTitle": "Prospective Randomized Placebo-Controlled Trial of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma (SURVIVE)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-11-18", "PrimaryCompletionDate": "2024-08-18", "Interventions": [ { "Name": "SurVaxM", "Type": "BIOLOGICAL", "Description": "Consists of a synthetic peptide conjugate that stimulates immune responses capable of killing cancer cells that express the survivin molecule. Multiple copies of the multiplied peptide (SVN53-67/M57) are conjugated to Keyhole Limpet Hemocyanin (KLH) yielding a molecule designated as SVN53-67/M57-KLH. The SVN53-67/M57-KLH conjugate (SurVaxM)produces immune responses in mice and humans that are cross-reactive to the wild-type survivin molecule expressed by tumor cells. The survivin peptide in SurVaxM is a defined antigenic peptide comprised of 15 amino acids that encompass multiple epitopes capable of binding human MHC Class I and murine H2-Kb molecules. SurVaxM also contains a core antigenic epitope that has been modified by substitution of methionine for cysteine at amino acid position 57 (i.e., M57).", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "MimiVax, LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Translational Drug Development", "Merit" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00498927", "BriefTitle": "Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma", "OfficialTitle": "A Phase II Trial of Continuous Low-Dose Temozolomide for Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-06", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "protein expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "reverse transcriptase-polymerase chain reaction", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "diagnostic laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "immunoenzyme technique", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Weill Medical College of Cornell University", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00200161", "BriefTitle": "Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma", "OfficialTitle": "A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-08-09", "PrimaryCompletionDate": "2017-05-04", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough", "Columbia University", "Dana-Farber Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03043391", "BriefTitle": "Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children", "OfficialTitle": "Phase Ib Study of Oncolytic Polio/Rhinovirus Recombinant Against Recurrent Malignant Glioma in Children", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-11-07", "PrimaryCompletionDate": "2022-03-23", "Interventions": [ { "Name": "Polio/Rhinovirus Recombinant (PVSRIPO)", "Type": "BIOLOGICAL", "Description": "PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Istari Oncology, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Solving Kids' Cancer", "The Andrew McDonough B+ Foundation", "Duke University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01770626", "BriefTitle": "A Pilot Study to Determine Nutrition Status in Glioblastoma Multiforme Patients", "OfficialTitle": "A Pilot Study to Determine the Effectiveness of Bioelectrical Impedance Analysis as a Clinical Assessment Tool of Nutrition Status in Glioblastoma Multiforme Patients (The BEAM Study [BIA Effectiveness as Assessment Tool for Glioblastoma Multiforme (GBM) Patients])", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2011-04", "PrimaryCompletionDate": "2013-07", "Interventions": [ { "Name": "Nutrition", "Type": "OTHER", "Description": "Anthropometrics, Nutrition assessment, Bioelectrical Impedance Analysis, Blood sample, Resting Energy Expenditure. All will be done 2-3 weeks after initial study visit and will continue every 3 months study visit except the Resting Energy Expenditure which will be performed at only one visit (2-3 weeks after initial visit).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05218408", "BriefTitle": "CYNK-001 IV and IC in Combination With IL2 in Surgical Eligible Recurrent GBM With IDH-1 Wild Type", "OfficialTitle": "A Phase I/IIa Open Label Multicenter, Non-Randomized, Trial to Assess the Safety and Efficacy of CYNK-001in Combination With Recombinant Human Interleukin-2 in Adults With Recurrent Resection Eligible IDH1 Wild-type Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-03-08", "PrimaryCompletionDate": "2024-02", "Interventions": [ { "Name": "CYNK-001 systemic and Intra cavity administration", "Type": "BIOLOGICAL", "Description": "Phase 1 Lymphodepletion Days -5,-4 and -3 Cyclophosphamide 900 mg/m2, Fludarabine 30 mg/m2 and Mesna per SOC\n\nIL 2 at 6M IU subcutaneous administration:\n\nFor IV cycle ( cycle1) rhIL2 will be administered on Days 1,3,5,8,9,11 and 15 . On days 1, 8 and 15 rhIL-2 will be administered 1 to 3 hours prior to CYNK-001 infusions For IC cycles rhIL2 will be administered 1 to 3 hours prior to each CYNK-001 IC dose.\n\nCYNK-001 : for IV at 2.4 x10\\^9 or 3.6 x10\\^9 cells Days 1,8 and 15\n\nTumor resection will take place 7 to 14 day follow by first IC cycle ( Cycle 2) at 100 Million cells or 200 Million cells\n\nIC cycles 3,4,5 once a week for three weeks , 28 days cycle at100 Million cells or 200 Million cells only for Phase 1 cohort 4 and Phase 2a", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Celularity Incorporated", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT01225510", "BriefTitle": "A Trial Of PF-04856884 In Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 2 Trial Of PF-04856884 (CVX-060), A Selective Angiopoietin-2 (Ang-2) Binding CovX-body, In Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2011-01", "PrimaryCompletionDate": "2013-01", "Interventions": [ { "Name": "PF-04856884", "Type": "BIOLOGICAL", "Description": "PF-04856884 at a dose of 15 mg/kg/week", "OtherNames": [ "CVX-060" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PF-04856884", "Type": "BIOLOGICAL", "Description": "PF-04856884 at a dose of 15 mg/kg/week", "OtherNames": [ "CVX-060" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pfizer", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05627323", "BriefTitle": "CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Phase 1b Study to Evaluate CHM-1101, a CAR T-Cell Therapy With a Chlorotoxin Tumor-Targeting Domain for Patients With Matrix Metallopeptidase 2 Positive (MMP2+) Recurrent or Progressive Glioblastoma Multiforme", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-06-06", "PrimaryCompletionDate": "2025-10", "Interventions": [ { "Name": "CHM-1101 CAR-T cells", "Type": "BIOLOGICAL", "Description": "Administered via ICT/ICV dual delivery", "OtherNames": [ "Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery)", "Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Chimeric Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03382977", "BriefTitle": "Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects", "OfficialTitle": "A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-12-06", "PrimaryCompletionDate": "2025-07", "Interventions": [ { "Name": "VBI-1901", "Type": "BIOLOGICAL", "Description": "The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carmustine", "Type": "DRUG", "Description": "Treatment with carmustine intravenously at a dose of 150 mg/m² on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.", "OtherNames": [ "BiCNU" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Treatment with lomustine given orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg) on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.", "OtherNames": [ "Gleostine" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "VBI Vaccines Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06319027", "BriefTitle": "Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial", "OfficialTitle": "Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-04-11", "PrimaryCompletionDate": "2027-05-31", "Interventions": [ { "Name": "Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo DSC-MRI", "OtherNames": [ "DSC", "DSC-MRI", "Dynamic Susceptibility Contrast-Enhanced MRI", "DYNAMIC SUSCEPTIBILITY-CONTRAST MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Fluciclovine F18", "Type": "OTHER", "Description": "Given IV", "OtherNames": [ "(18F)Fluciclovine", "(18F)GE-148", "18F-Fluciclovine", "[18F]FACBC", "Anti-(18f)FABC", "Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid", "Anti-[18F] FACBC", "Axumin", "Fluciclovine (18F)", "FLUCICLOVINE F-18", "GE-148 (18F)", "GE-148 F-18" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gadolinium-Chelate", "Type": "DRUG", "Description": "Receive gadolinium-based contrast agent", "OtherNames": [ "Gadolinium Coordination Complex", "Gadolinium-based Contrast Agent", "Gadolinium-Chelant Complex" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Spectroscopy", "Type": "PROCEDURE", "Description": "Undergo MR spectroscopy", "OtherNames": [ "NMR Spectroscopy", "NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY", "Spectroscopy, MR", "Spectroscopy, NMR", "Spectroscopy, Nuclear Magnetic Resonance" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET scan", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron emission tomography (procedure)", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging", "PT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "ECOG-ACRIN Cancer Research Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03480867", "BriefTitle": "Pre-operative RT and TMZ in Patients With Newly Diagnosed GBM Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)", "OfficialTitle": "Pre-operative Radiation Therapy (RT) and Temozolomide (TMZ) in Patients With Newly Diagnosed Glioblastoma. A Phase I Study. (PARADIGMA)", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2017-03", "PrimaryCompletionDate": "2021-06", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Experimental: Registered one arm study Seven days of pre-operative Radiation+Temozolomide followed by surgery plus TMZ, as adjuvant component.for six cycles.", "OtherNames": [ "Surgery" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Pre-Operative Radiation", "Type": "RADIATION", "Description": "Radiation is given with Temozolomide for 7 days before surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "McGill University Health Centre/Research Institute of the McGill University Health Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04224441", "BriefTitle": "Repurposing Chlorpromazine in the Treatment of Glioblastoma", "OfficialTitle": "Repurposing the Antipsychotic Drug Chlorpromazine as a Therapeutic Agent in the Combined Treatment of Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2019-12-15", "PrimaryCompletionDate": "2022-06-15", "Interventions": [ { "Name": "Chlorpromazine Pill", "Type": "DRUG", "Description": "The experimental treatment involves the combination of chlorpromazine to the standard treatment with temozolomide solely in the adjuvant phase (after radio-chemotherapy, temozolomide for 5 days every 28, at a dose of 150-200 mg/mq for 6 cycles) of the Stupp protocol. Chlorpromazine will be administered at a dose of 50 mg/day concomitantly with the adjuvant treatment with temozolomide", "OtherNames": [ "Temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Marco G Paggi, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Regina Elena Cancer Institute", "Carlo Besta Neurological Institute", "Istituto Oncologico Veneto IRCCS" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07134842", "BriefTitle": "A Study Assessing if it is Safe and Possible to Treat Brain Cancer Patients With Immunotherapy Before They Receive the Standard Treatment.", "OfficialTitle": "Window Studies in Glioblastoma: A Phase I Trial Investigating Neoadjuvant Ipilimumab in Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-10", "PrimaryCompletionDate": "2027-01-01", "Interventions": [ { "Name": "Ipilimumab (3 mg/kg)", "Type": "BIOLOGICAL", "Description": "All participants will be treated with ipilimumab (3mg/kg) for up to 2 cycles. Each cycle will last 21 days with participants receiving ipilimumab on the 1st day of the cycle.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4" ], "classes": [] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4" ], "classes": [] } }, { "NCTId": "NCT07067905", "BriefTitle": "Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma", "OfficialTitle": "Clinical Evaluation of [68Ga]Ga-XT771 PET for Diagnosis in Patients With Glioblastoma and Clear Cell Renal Cell Carcinoma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-06-27", "PrimaryCompletionDate": "2026-04-01", "Interventions": [ { "Name": "68Ga-XT771", "Type": "DRUG", "Description": "68Ga-XT771 is injected intravenously with a dose of 4-8 mCi", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Chinese PLA General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Sinotau Pharmaceutical Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01975701", "BriefTitle": "A Phase 2 Study of BGJ398 in Patients With Recurrent GBM", "OfficialTitle": "A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-12-09", "PrimaryCompletionDate": "2018-10-03", "Interventions": [ { "Name": "BGJ398", "Type": "DRUG", "Description": "Capsule for oral use.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02465528", "BriefTitle": "Ceritinib Rare Indications Study in ALK+ Tumors", "OfficialTitle": "A Phase II, Open Label, Multi-center, Multi-arm Study of Ceritinib in Patients With Advanced Solid Tumors and Hematological Malignancies Characterized by Genetic Abnormalities of Anaplastic Lymphoma Kinase (ALK)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2016-05-06", "PrimaryCompletionDate": "2018-08-20", "Interventions": [ { "Name": "Ceritinib (LDK378)", "Type": "DRUG", "Description": "Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00128700", "BriefTitle": "Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study on Concomitant and Adjuvant Temozolomide and Radiotherapy With or Without PTK787/ZK222584 in Newly Diagnosed GBM", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-06", "PrimaryCompletionDate": "2007-11", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "vatalanib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02414165", "BriefTitle": "The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma", "OfficialTitle": "A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2015-11-30", "PrimaryCompletionDate": "2019-05-31", "Interventions": [ { "Name": "Toca 511", "Type": "BIOLOGICAL", "Description": "Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector.", "OtherNames": [ "vocimagene amiretrorepvec", "RRV", "retroviral replicating vector" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC", "Type": "DRUG", "Description": "Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets", "OtherNames": [ "flucytosine", "5-FC", "5-fluorocytosine" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": null, "OtherNames": [ "CCNU", "CeeNU" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05735171", "BriefTitle": "Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence", "OfficialTitle": "Tailored Supramarginal Resection in Glioblastoma Guided by Artificial Intelligence-based Recurrence Probability Maps. A Non-randomized Pilot Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2022-11-01", "PrimaryCompletionDate": "2025-05-30", "Interventions": [ { "Name": "AI-guided surgery", "Type": "PROCEDURE", "Description": "Neuronavigated targeted biopsy sampling. Supramarginal resection including high-risk areas of recurrence defined by a radiomics-based model.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hospital del Rio Hortega", "LeadSponsorClass": "OTHER", "Collaborators": [ "UiT The Arctic University of Norway", "University Hospital of North Norway", "University of Valladolid" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04424966", "BriefTitle": "Infigratinib in Recurrent High-Grade Glioma Patients", "OfficialTitle": "A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-07-21", "PrimaryCompletionDate": "2023-01-31", "Interventions": [ { "Name": "Infigratinib", "Type": "DRUG", "Description": "The Phase 0 study will include treatment of recurrent high-grade glioma participants with 125 mg of infigratinib 7 days prior to surgical resection. Participants with tumors demonstrating PK-response will continue treatment with the same dose continuously for 21 days in 28-day cycles after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ivy Brain Tumor Center", "Barrow Neurological Institute", "QED Therapeutics, a BridgeBio company" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04205357", "BriefTitle": "Sulfasalazine and Stereotactic Radiosurgery for Recurrent Glioblastoma", "OfficialTitle": "Phase I Trial Combining Sulfasalazine and Gamma Knife Radiosurgery for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2020-03-01", "PrimaryCompletionDate": "2022-10-14", "Interventions": [ { "Name": "Sulfasalazine", "Type": "DRUG", "Description": "Sulfasalazine combined with stereotactic radiosurgery", "OtherNames": [ "Stereotactic radiosurgery" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Haukeland University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Norwegian Cancer Society", "Northwell Health", "Weill Medical College of Cornell University", "University of Bergen", "Helse Stavanger HF" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03405792", "BriefTitle": "Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)", "OfficialTitle": "Phase 2, Single Arm, Historically Controlled Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-02-23", "PrimaryCompletionDate": "2022-11-26", "Interventions": [ { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Patients will begin treatment with adjuvant TMZ at least 4 weeks but no more than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and maximum of 12 cycles of adjuvant TMZ will be given depending on tolerability and toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Optune System", "Type": "DEVICE", "Description": "Patients will undergo 24-months of planned treatment with Optune therapy.", "OtherNames": [ "NovoTTF Therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab will be given intravenously every 3 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. Treatment with pembrolizumab every 3 weeks until first disease progression or unacceptable toxicities or 2 years, whichever comes first.", "OtherNames": [ "Keytruda" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01189513", "BriefTitle": "SCH-900105 in Recurrent Glioblastoma", "OfficialTitle": "A Phase I Evaluation of SCH 900105 With Correlative Tissue Studies in the Treatment of Adult Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2011-01", "Interventions": [ { "Name": "SCH 900105", "Type": "DRUG", "Description": "10 mg/kg by vein every week on days 1, 8 and 15 of a 30 day cycle.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006368", "BriefTitle": "Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer", "OfficialTitle": "A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-01", "PrimaryCompletionDate": "2003-11", "Interventions": [ { "Name": "yttrium Y 90-edotreotide", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02227576", "BriefTitle": "Prevention of Thrombocytopenia in Glioblastoma Patients", "OfficialTitle": "Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-07-10", "PrimaryCompletionDate": "2017-12-14", "Interventions": [ { "Name": "Romiplostim", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital, Lille", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07120620", "BriefTitle": "PriCoTTF Study: TTFields Before and During Radiotherapy for Newly Diagnosed Glioblastoma", "OfficialTitle": "PriCoTTF Study: A Phase I/II Study With TTFields Before and During Radiotherapy in Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-06-25", "PrimaryCompletionDate": "2023-08-28", "Interventions": [ { "Name": "TTFields before and during radiotherapy", "Type": "DEVICE", "Description": "Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm A)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "TTFields before and during radiotherapy", "Type": "DEVICE", "Description": "Administration of TTFields before and during radiation therapy in patients with primary glioblastoma (Arm B)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sied Kebir", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00042991", "BriefTitle": "Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas", "OfficialTitle": "Phase I/II Trial of Gefitinib and Radiation in Pediatric Patients Newly Diagnosed With Brain Stem Tumors or Incompletely Resected Supratentorial Malignant Gliomas With Phase II Limited to Brain Stem Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-07", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "gefitinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "Iressa" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo standard brain irradiation", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03466450", "BriefTitle": "Glasdegib (PF-04449913) With Temozolomide Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase Ib/II Multicentric Study Combining Glasdegib (PF-04449913) With Temozolomide in Patients With Newly Diagnosed Glioblastoma, Safety and Preliminary Efficacy for the Combination", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-03-15", "PrimaryCompletionDate": "2023-11-29", "Interventions": [ { "Name": "PF-04449913", "Type": "DRUG", "Description": "Glasdegib (3 dose levels will be evaluated: 100mg QD, 150mg QD and 200mg QD, or 75-50mg) will be administered:\n\nDuring concurrent phase concomitantly with radiation and Extended to the resting period (glasdegib will not be stopped in the 4 weeks of radiotherapy resting period).\n\nDuring adjuvant therapy with Temozolomide Oral Capsule. Additional treatment with glasdegib beyond 6 sequential TMZ cycles will continue until progression, unacceptable toxicity, non-compliance, consent withdrawal and/or 2 years of glasdegib administration.", "OtherNames": [ "Glasdegib" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide Oral Capsule", "Type": "DRUG", "Description": "During RT, patients will receive Temozolamide (TMZ). All patients will be given TMZ at 75 mg/m2\n\n/d concurrently with RT for a maximum of 42 days. At 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06552260", "BriefTitle": "A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma", "OfficialTitle": "A Surgical Window of Opportunity Clinical Trial of Troriluzole in Recurrent IDH Wild-Type Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-02-19", "PrimaryCompletionDate": "2026-08-01", "Interventions": [ { "Name": "Troriluzole", "Type": "DRUG", "Description": "Tripeptide prodrug of Riluzole, 100 mg capsule, taken orally per protocol.", "OtherNames": [ "Trigriluzole", "BHV-4157", "FC-4157", "2-Amino-N-({methyl-[(6-trifluoromethoxy-benzothiazol-2-ylcarbamoyl)-methyl]-carbamoyl}-methyl)-acetamide monohydrate monohydrochloride", "C15H16F3N5O4S.HCl.H2O" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [] } } ], "LeadSponsorName": "Ugonma Chukwueke", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)", "Biohaven Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH", "MET" ], "classes": [] } }, { "NCTId": "NCT01808820", "BriefTitle": "Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma", "OfficialTitle": "Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-08-21", "PrimaryCompletionDate": "2018-11-07", "Interventions": [ { "Name": "Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.", "OtherNames": [ "DC Vaccine" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor Lysate", "Type": "BIOLOGICAL", "Description": "Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.", "OtherNames": [ "Lysate of Tumor", "Lysate Boost" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Imiquimod", "Type": "DRUG", "Description": "5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate", "OtherNames": [ "Aldara" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Leukapheresis", "Type": "PROCEDURE", "Description": "Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.", "OtherNames": [ "Pheresis" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Macarena De La Fuente, MD", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00424060", "BriefTitle": "Epothilone ZK-219477 in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-12", "PrimaryCompletionDate": "2007-08", "Interventions": [ { "Name": "sagopilone", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "fluorescence in situ hybridization", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "gene expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01782976", "BriefTitle": "Ph II Cilengitide Plus Bevacizumab for Recurrent Glioblastoma (GBM)", "OfficialTitle": "A Phase II Trial of Cilengitide Plus Bevacizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2013-06", "PrimaryCompletionDate": "2017-06", "Interventions": [ { "Name": "Cilengitide", "Type": "DRUG", "Description": "2000 mg by vein twice weekly of each 28 day cycle.", "OtherNames": [ "EMD 121974" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "10 mg/kg by vein on Days 1 and 15 of each 28 day cycle.", "OtherNames": [ "Avastin", "Anti-VEGF monoclonal antibody", "rhuMAb-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Questionnaire", "Type": "BEHAVIORAL", "Description": "Completion of MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) at baseline, Day 1 of cycle 2, and at end of treatment visit. Questionnaire should take about 5 minutes to complete.", "OtherNames": [ "Survey" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Brain Tumor Trials Collaborative", "EMD Serono" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01778530", "BriefTitle": "TRC105 for Recurrent Glioblastoma", "OfficialTitle": "A Phase 2 Study of TRC105 in Patients With Recurrent Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2012-12", "PrimaryCompletionDate": "2014-02", "Interventions": [ { "Name": "TRC105", "Type": "DRUG", "Description": "Intravenous infusion.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07076472", "BriefTitle": "Sonodynamic Therapy With SONALA-001 and Magnetic Resonance Guided Focused Ultrasound for the Treatment of Progressive or Recurrent Glioblastoma", "OfficialTitle": "MC240704 Phase 1B Dose Escalation And Expansion Study of Sonodynamic Therapy With SONALA-001 in Combination With Exablate 4000 Type 2.0 MR-Guided Focused Ultrasound (MRgFUS) in Patients With Progressive or Recurrent Glioblastoma Multiforme (rGBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-08-14", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Aminolevulinic Acid Intravenous Formulation SONALA-001", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "ALA Intravenous Formulation SONALA-001", "SONALA 001", "SONALA-001", "SONALA001" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized axial tomography (procedure)", "Computerized Tomography", "Computerized Tomography (CT) scan", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Electronic Health Record Review", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MRI-Guided Focused Ultrasound Ablation", "Type": "PROCEDURE", "Description": "Undergo transcranial MRgFUS", "OtherNames": [ "Magnetic Resonance Imaging-guided High-Intensity Focused Ultrasound", "Magnetic Resonance-guided Focused Ultrasound", "MR-HIFU", "MRgFUS", "MRI Guided Focused Ultrasound Surgery", "MRI-HIFU" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01032200", "BriefTitle": "Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors", "OfficialTitle": "A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-08-01", "PrimaryCompletionDate": "2013-01-08", "Interventions": [ { "Name": "Armodafinil", "Type": "DRUG", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "placebo", "Type": "OTHER", "Description": "Given orally", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00014677", "BriefTitle": "NBI-3001 Followed by Surgery in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Randomized, Dose-Ranging, Safety and Tolerability Study of NBI-3001 Administered by Continuous Intratumoral Infusion Followed by Surgical Resection in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-03", "PrimaryCompletionDate": "2002-09", "Interventions": [ { "Name": "interleukin-4 PE38KDEL cytotoxin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Neurocrine Biosciences", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07021339", "BriefTitle": "Anterior Temporal Lobectomy in Temporal Glioblastoma", "OfficialTitle": "Randomized, Controlled Trial of Anterior Temporal Lobectomy Versus Gross Total Resection in Newly-diagnosed Temporal Glioblastoma (ATLAS/NOA-29)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-11-28", "PrimaryCompletionDate": "2028-02-28", "Interventions": [ { "Name": "Anterior temporal lobectomy (ATL)", "Type": "PROCEDURE", "Description": "Patients assigned to the experimental group will undergo an anterior temporal lobectomy (ATL) according to established protocols adapted from epilepsy surgery. ATL is a reproducible and anatomically well-defined procedure routinely performed in patients with pharmacoresistant temporal lobe epilepsy. On the non-dominant hemisphere, the neocortical resection typically extends 6.5 cm posteriorly from the temporal pole, while on the dominant side, the resection length is limited to 4.0 cm, both measured along the superior temporal gyrus and guided by the Sylvian fissure. Language dominance is determined based on handedness, as specified in the inclusion criteria. In most cases, the lateral neocortical segment can be removed en bloc.\n\nThe mesial component of ATL encompasses resection of the uncus, amygdala, and the anterior hippocampus, typically including both the head and body. Resection is carried out to the level of the tectal plate or, at minimum, to the lateral mesencephalic sulcus.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gross Total Resection (GTR)", "Type": "PROCEDURE", "Description": "Patients will be surgically treated with GTR in terms of removing 100% of the tumor tissue in gadolinium-enhanced MRI.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital, Bonn", "LeadSponsorClass": "OTHER", "Collaborators": [ "University Hospital RWTH Aachen, Department of Neurosurgery", "Kantonsspital Aarau, Department of Neurosurgery", "University Hospital Bonn, Department of Neurosurgery", "Dortmund Hospital, Neurosurgical Department", "Helios Kliniken, Erfurt, Department of Neurosurgery", "University Hospital Essen, Department of Neurosurgery and Spine Surgery", "University Hospital Frankfurt, Department of Neurosurgery", "University Hospital Giessen, Department of Neurosurgery", "University Medical Center Göttingen, Department of Neurosurgery", "University Medical Center Hamburg-Eppendorf, Department of Neurosurgery", "Heidelberg University Hospital, Department of Neurosurgery", "Jena University Hospital, Department of Neurosurgery", "University of Cologne, Center of Neurosurgery Department of General Neurosurgery", "University Hospital Leipzig, Department of Neurosurgery", "University Medical Center Schleswig-Holstein/Lübeck, Department of Neurosurgery", "Medical Faculty University Hospital Magdeburg, University Clinic for Neurosurgery", "University Medical Center Mainz, Department of Neurosurgery", "University Hospital Mannheim, Medical Faculty Mannheim, Department of Neurosurgery", "Klinikum Rechts der Isar, Technical University of Munich, Department of Neurosurgery", "LMU University Hospital, Department of Neurosurgery", "University Hospital of Münster, Department of Neurosurgery", "University Hospital Regensburg, Department of Neurosurgery", "University Medical Centre Rostock, Department of Neurosurgery", "University Hospital Tübingen, Department of Neurosurgery", "University Hospital Ulm/Günzburg, University of Ulm, Department of Neurosurgery", "Medical University of Vienna, Department of Neurosurgery" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03903419", "BriefTitle": "Feasibility Study of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT in Glioblastoma's Patients", "OfficialTitle": "Feasibility Study for the Realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for Identification of Early Recurrence in Patients Treated With Radiotherapy for Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2019-01-16", "PrimaryCompletionDate": "2021-08-16", "Interventions": [ { "Name": "Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.", "Type": "DIAGNOSTIC_TEST", "Description": "This study is a non-randomized, prospective, feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.\n\nPatients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Leon Berard", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06177964", "BriefTitle": "Lerapolturev (PVSRIPO) in GBM", "OfficialTitle": "Randomized Phase 2 Clinical Trial of Repeated Intratumoral and Cervical Perilymphatic Lerapolturev Injections Versus Lomustine in Recurrent Glioblastoma (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-07-15", "PrimaryCompletionDate": "2029-02", "Interventions": [ { "Name": "Lerapolturev", "Type": "DRUG", "Description": "Lerapolturev (intratumoral) will be dosed at 2x108 TCID50 in 3.0 mL x 2 doses (total dose 4x108 TCID50) by Convection Enhanced Delivery.\n\nFor the patients randomized to the lerapolturev Arm 1 of Stage 2, seven days (±2 days) following completion of the 2nd intratumoral infusion of lerapolturev, patients will begin cervical perilymphatic subcutaneous injection of lerapolturev at a dose of 2 x 108 TCID50 (in 0.5 ml diluent) around the cervical lymph node chain ipsilateral to the intracranial tumor.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine Pill", "Type": "DRUG", "Description": "Lomustine will be given as a single oral dose of 110 mg/m2 every six weeks for up to 9 cycles.", "OtherNames": [], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Istari Oncology, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06929819", "BriefTitle": "Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor", "OfficialTitle": "Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-06-01", "PrimaryCompletionDate": "2027-05-31", "Interventions": [ { "Name": "Intraoperative Radiation Therapy in Malignant Cerebral Tumor", "Type": "RADIATION", "Description": "This technique can fully expose the tumor bed during the operation, and pull the brain tissue around the tumor under the microscope to de-radiation, so as to exceed the total dose level of standard conformal conventional external radiation therapy (EBRT), maximize the radiobiological effect of a single high-dose irradiation, and deliver precise radiation to the tumor bed, while minimizing the radiation dose of peripheral nerve tissue. This technique is also a good choice for patients with orthotopic recurrent tumors who can no longer tolerate one more EBRT. Intraoperative radiotherapy technology can reduce the chance of postoperative tumor recurrence and improve the survival and prognosis of patients by providing a higher effective total dose to the tumor bed, while promoting dose escalation without significantly increasing the occurrence of complications in normal tissues, and improving the local control rate.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "First Affiliated Hospital, Sun Yat-Sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00657267", "BriefTitle": "Dose-Intense Temozolomide in Recurrent Glioblastoma", "OfficialTitle": "Phase 2 Study of Dose-Intense Temozolomide in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-05", "PrimaryCompletionDate": "2011-11", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Taken orally daily for the first three weeks of a four-week cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Patrick Y. Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Brigham and Women's Hospital", "Massachusetts General Hospital", "University of Pennsylvania", "Wake Forest University Health Sciences", "Tufts Medical Center", "Dartmouth-Hitchcock Medical Center", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00110032", "BriefTitle": "Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors", "OfficialTitle": "Microenvironment: Imaging/Implications in Brain Tumors; A Preliminary Investigation of the Biodistribution of [F-18]-EF5 in Patients With Brain Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2005-06", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "EF5", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [ "surgery, conventional" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "positron emission tomography", "Type": "PROCEDURE", "Description": "Undergo PET", "OtherNames": [ "FDG-PET", "PET", "PET scan", "tomography, emission computed" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "fluorine F 18 EF5", "Type": "RADIATION", "Description": "Given IV", "OtherNames": [ "18F-EF5" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05871021", "BriefTitle": "Protective VEGF Inhibition for Isotoxic Dose Escalation in Glioblastoma", "OfficialTitle": "A Phase IIa, Open-label, Multicenter Study of Radiochemotherapy With Isotoxic Dose Escalation and Protective VEGF Inhibition Using Bevacizumab in the Treatment of Patients With First Diagnosis of IDH Wild-type, MGMT Unmethylated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-04-10", "PrimaryCompletionDate": "2028-04-10", "Interventions": [ { "Name": "Dose escalation of radiation dose beyond the therapeutic standard", "Type": "RADIATION", "Description": "Dose escalation to 75 Gy with concomitant radioprotectant bevacizumab", "OtherNames": [ "bevacizumab" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University Hospital Tuebingen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "MGMT", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04678648", "BriefTitle": "A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies", "OfficialTitle": "A Phase Ia/Ib, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of RSC-1255 Alone or in Combination With Hydroxychloroquine in Patients With Advanced Solid Tumor Malignancies", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-03-03", "PrimaryCompletionDate": "2026-12-15", "Interventions": [ { "Name": "RSC-1255 Dose Escalation", "Type": "DRUG", "Description": "Phase 1a will enroll 40-80 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, with and without food. Each cycle is 21 days.", "OtherNames": [ "Phase 1a", "Dose Escalation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "RSC-1255 Dose Expansion", "Type": "DRUG", "Description": "Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days.", "OtherNames": [ "Phase 1b", "Dose Expansion" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "RasCal Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00492687", "BriefTitle": "Radiation Therapy, Temozolomide, Tamoxifen, and Carboplatin in Treating Patients With Malignant Gliomas", "OfficialTitle": "A Phase II Pilot Trial of Radiation Therapy With Concurrent and Adjuvant Temozolomide, Tamoxifen and Carboplatin (T2C) in the Treatment of Patients With Primary Central Nervous System Malignant Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2006-12", "PrimaryCompletionDate": "2009-07", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "tamoxifen citrate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "San Diego Pacific Oncology & Hematology Associates", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05561374", "BriefTitle": "Study of Safety and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma", "OfficialTitle": "A Phase 1b Open-Label Study Investigating the Tolerability, Safety, and Pharmacokinetic Properties of Oral OKN-007 in Patients with Recurrent High-Grade Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-17", "PrimaryCompletionDate": "2025-05-31", "Interventions": [ { "Name": "Low-dose OKN-007, BID", "Type": "DRUG", "Description": "Participants will be administered low doses of oral OKN-007 two times a day daily in 28-day cycles.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Low-dose OKN-007, TID", "Type": "DRUG", "Description": "Participants will be administered low doses of oral OKN-007 three times a day daily in 28-day cycles.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Mid-dose OKN-007, TID", "Type": "DRUG", "Description": "Participants will be administered mid doses of oral OKN-007 three times a day daily in 28-day cycles.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "High-dose OKN-007, TID", "Type": "DRUG", "Description": "Participants will be administered high doses of oral OKN-007 three times a day daily in 28-day cycles.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oblato, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01730950", "BriefTitle": "Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-12-20", "PrimaryCompletionDate": "2018-09-03", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Staring within 14 days of randomization, IV 10mg/kg every two weeks until disease progression.", "OtherNames": [ "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "Avastin", "rhuMAb VEGF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Starting with second dose of bevacizumab, 35 Gy in 10 fractions of 3.5 Gy each delivered on consecutive treatment days (typically 5 fractions per week).", "OtherNames": [ "3D conformal radiation therapy", "photon beam radiation therapy", "proton beam radiation therapy", "Intensity Modulated Radiation Therapy (IMRT)", "Image-Guided Radiation Treatment (IGRT)", "3D-CRT" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03722355", "BriefTitle": "Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma", "OfficialTitle": "A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "1990-11-09", "PrimaryCompletionDate": "1994-03-15", "Interventions": [ { "Name": "Conventional RT", "Type": "RADIATION", "Description": "Radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Hyperfractionated RT", "Type": "RADIATION", "Description": "Radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Carmustine", "Type": "DRUG", "Description": "Chemotherapy", "OtherNames": [ "BCNU", "Gliadel" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05736406", "BriefTitle": "A Dose-escalation Clinical Study of Intraoperative Photodynamic Therapy of Glioblastoma", "OfficialTitle": "An Interventional, Multicenter, and International Phase 1/2, Light-dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance® Solution Device in Male and Female Patients 18 to 75 Years of Age With Grade IV Glioblastoma.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-02-20", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 200 J/cm^2", "Type": "COMBINATION_PRODUCT", "Description": "5-ALA HCl, 20 mg/kg, is orally administered 4-6 hours before the surgery. Then after resection of tumor tissue is judged maximal, the intraoperative PDT procedure is initiated at 200 J/cm\\^2.", "OtherNames": [ "Pentalafen®", "5-aminolevulinic acid hydrochloride", "Heliance® Solution", "5-ALA PDT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "5-ALA HCl intraoperative Photodynamic Therapy (PDT) at 400 J/cm^2", "Type": "COMBINATION_PRODUCT", "Description": "5-ALA HCl, 20 mg/kg, is orally administered 4-6 hours before the surgery. Then after resection of tumor tissue is judged maximal, the intraoperative PDT procedure is initiated at 400 J/cm\\^2.", "OtherNames": [ "Pentalafen®", "5-aminolevulinic acid hydrochloride", "Heliance® Solution", "5-ALA PDT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hemerion Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00027625", "BriefTitle": "Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma", "OfficialTitle": "A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-01-28", "PrimaryCompletionDate": "2005-03-17", "Interventions": [ { "Name": "gefitinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT04869449", "BriefTitle": "Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas", "OfficialTitle": "Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas: A Phase 0 Clinical Trial", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-05-11", "PrimaryCompletionDate": "2022-05-12", "Interventions": [ { "Name": "Ketoconazole", "Type": "DRUG", "Description": "400 mg (two 200 mg tablets) orally", "OtherNames": [ "Nizoral" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Milton S. Hershey Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00615186", "BriefTitle": "Glioblastoma Multiforme (GBM) Locoregional Agent Survival Study - Anti-tenascin Radiolabeled Antibody Therapy", "OfficialTitle": "A Phase III Randomized Study of Neuradiab in Combination With External Beam Radiation and Temozolomide Versus External Beam Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2008-06", "PrimaryCompletionDate": "2013-08", "Interventions": [ { "Name": "Neuradiab + Radiotherapy + Temozolomide", "Type": "DRUG", "Description": "Prior Surgery\n\nRickham Catheter placement 99mTc-DTPA Flow Study\n\nNeuradiab Dosimetry Study\n\nNeuradiab Therapeutic Dose Administration\n\nRadiation Therapy (XRT) + Temozolomide:\n\nXRT 5 days/week + temozolomide (75 mg/m2/day) over 6.5 weeks.\n\nPost-Radiation Temozolomide Therapy:\n\nTemozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy + Temozolomide", "Type": "DRUG", "Description": "Prior Surgery: Gross total resection (\\< 1 cm. enhancing rim)\n\nRadiation Therapy (XRT) + Temozolomide:\n\nXRT 5 days/week + 42 days of temozolomide (75 mg/m2/day) over 6.5 weeks\n\nPost-Radiation Temozolomide Therapy:\n\nTemozolomide 150-200 mg/m2/day × 5 days, every 28 days until patient's death, confirmed disease progression, unacceptable toxicity, non-compliance with the protocol, withdrawal of consent, and/or other factor that in the opinion of the consulting oncologist precludes continued study treatment.", "OtherNames": [ "Temodar (US)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bradmer Pharmaceuticals Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02709889", "BriefTitle": "Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors", "OfficialTitle": "An Open-Label Study of Rovalpituzumab Tesirine in Subjects With Delta-Like Protein 3-Expressing Advanced Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-09-23", "PrimaryCompletionDate": "2019-08-27", "Interventions": [ { "Name": "Rovalpituzumab tesirine", "Type": "DRUG", "Description": null, "OtherNames": [ "SC16LD6.5" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dexamethasone", "Type": "DRUG", "Description": "Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00006355", "BriefTitle": "Pyrazoloacridine Followed by Radiation Therapy in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study of Pyrazoloacridine (PZA) in Adults With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-05", "PrimaryCompletionDate": "2004-10", "Interventions": [ { "Name": "pyrazoloacridine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00762255", "BriefTitle": "A Phase I Trial of Vorinostat in Combination With Bevacizumab & Irinotecan in Recurrent Glioblastoma", "OfficialTitle": "A Phase I Trial of Vorinostat in Combination With Bevacizumab and Irinotecan in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-09", "PrimaryCompletionDate": "2013-07", "Interventions": [ { "Name": "Vorinostat", "Type": "DRUG", "Description": "Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.", "OtherNames": [ "NSC 701852" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.", "OtherNames": [ "rhuMAb VEGF", "Avastin", "NSC 704865" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Vorinostat, Bevacizumab and Irinotecan Study. Determine maximum tolerated dose for treatment.", "OtherNames": [ "Camptosar", "CPT-11", "NSC 616348" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "H. Lee Moffitt Cancer Center and Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03896568", "BriefTitle": "MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-02-12", "PrimaryCompletionDate": "2027-09-30", "Interventions": [ { "Name": "Oncolytic Adenovirus Ad5-DNX-2401", "Type": "BIOLOGICAL", "Description": "Given IA", "OtherNames": [ "Ad5-Delta24RGD", "DNX-2401", "DNX2401", "Oncolytic Ad5-Delta 24RGD", "Oncolytic Adenovirus Ad5-Delta 24RGD" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "DNAtrix, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04201873", "BriefTitle": "Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma", "OfficialTitle": "Phase I Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the PD-1 Antibody Pembrolizumab With Autologous Tumor Lysate-Pulsed Dendritic Cell Vaccination in Patients With Surgically Accessible Recurrent/Progressive Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-01-08", "PrimaryCompletionDate": "2026-08-01", "Interventions": [ { "Name": "Dendritic Cell Tumor Cell Lysate Vaccine", "Type": "BIOLOGICAL", "Description": "Given ID", "OtherNames": [ "DC tumor cell lysate vaccine", "dendritic cell-pulsed tumor cell lysate vaccine" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Placebo Administration", "Type": "OTHER", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Poly ICLC", "Type": "DRUG", "Description": "Given IM", "OtherNames": [ "Hiltonol", "Poly I:Poly C with Poly-L-Lysine Stabilizer", "poly-ICLC", "PolyI:PolyC with Poly-L-Lysine Stabilizer", "Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose", "Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose", "Stabilized Polyriboinosinic/Polyribocytidylic Acid" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Merck Sharp & Dohme LLC", "Phase One Foundation", "Oncovir, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT04752813", "BriefTitle": "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)", "OfficialTitle": "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-08-22", "PrimaryCompletionDate": "2026-08-25", "Interventions": [ { "Name": "BPM31510", "Type": "DRUG", "Description": "Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Vitamin K1", "Type": "OTHER", "Description": "Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg subcutaneously prior to the beginning of each week of BPM31510 therapy.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "BPGbio", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06816927", "BriefTitle": "Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab", "OfficialTitle": "A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab (GIANT)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-11-28", "PrimaryCompletionDate": "2029-06-01", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "For Neoadjuvant treatment, on both Arms 1 and 2, all 92 patients will receive single dose of 480 mg by IV infusion on Day 1 followed by surgery. Post-resection, in Part 1 Adjuvant treatment, all patients will receive two doses of 480 mg of nivolumab by IV infusion on Days 1 and 29. In Part 2 Adjuvant Treatment of Nivolumab dosing will continue for up to 12 cycles. Each cycle is 28 Days long.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Relatlimab", "Type": "DRUG", "Description": "For Neoadjuvant treatment, only on Arm 2, 69 patients will receive a single dose of 480 mg of nivolumab and 480 mg of relatimab by IV infusions on Day 1 followed by surgery. Post resection in Part 1 Adjuvant treatment, all patients will receive two doses of 480 mg of nivolumab and relatlimab by IV infusion on Days 1 and 29. In Part 2 Adjuvant Treatment of Relatimab dosing will continue for up to 12 cycles. Each cycle is 28 Days long.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "TMZ", "Type": "DRUG", "Description": "All patients in safety lead-in, Arm 1 and Arm 2 post resection in Part 1 Adjuvant Treatment setting will receive 75 mg/m2 TMZ from Day 1 to Day 42 orally. In Part 2 Adjuvant Treatment of TMZ dosing with TMZ will continue for up to 6 cycles with 150 mg/m2 for cycle 3 and escalating to 200 mg/m2 for cycles 4 to 8 day 1 to 5 for these 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "All patients in safety lead-in, Arm 1 and Arm 2 post resection in Part 1 Adjuvant Treatment will receive External Beam Radiation 2 Gy/day (60 Gy in total) Once daily, 5 days per week, for 6 weeks Starting on Day 1", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03434262", "BriefTitle": "SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors", "OfficialTitle": "Molecularly-Driven Doublet Therapy for All Children With Refractory or Recurrent CNS Malignant Neoplasms and Young Adults With Refractory or Recurrent SHH Medulloblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-03-05", "PrimaryCompletionDate": "2022-09-30", "Interventions": [ { "Name": "Gemcitabine", "Type": "DRUG", "Description": "Given intravenously (IV).", "OtherNames": [ "Gemzar®" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "ribociclib", "Type": "DRUG", "Description": "Given orally (PO).", "OtherNames": [ "LEE011", "LEE-011", "KISQALI®" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "sonidegib", "Type": "DRUG", "Description": "Given PO.", "OtherNames": [ "LDE225", "LDE-225", "ODOMZO®" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "trametinib", "Type": "DRUG", "Description": "Given PO.", "OtherNames": [ "TMT212", "TMT-212", "MEKINIST(TM)" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Given subcutaneously (SQ).", "OtherNames": [ "G-CSF" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "MEK", "MET" ], "classes": [ "Cell cycle inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT03251027", "BriefTitle": "Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma", "OfficialTitle": "Intensity-Modulated Stereotactic Radiotherapy as an Upfront Scalp-Sparing Intervention for the Treatment of Newly Diagnosed Grade II-IV Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2017-07-17", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo IM-SRT", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment", "Quality-of-Life Assessment" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Cancer Center at Thomas Jefferson University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03869242", "BriefTitle": "NovoTTF-200A Together With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed GBM", "OfficialTitle": "A Prospective, Randomized, Single-center Trial of NovoTTF-200A Together With Radiation Therapy and Temozolomide Compared to Radiation Therapy and Temozolomide Alone in Patients With Newly Diagnosed GBM", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2018-10-01", "PrimaryCompletionDate": "2021-03-01", "Interventions": [ { "Name": "NovoTTF-200A", "Type": "DEVICE", "Description": "newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Tel-Aviv Sourasky Medical Center", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03958240", "BriefTitle": "Deciphering Mechanisms Underlying Cancer Immunogenicity", "OfficialTitle": "Deciphering Mechanisms Underlying Cancer Immunogenicity", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-01-17", "PrimaryCompletionDate": "2033-01", "Interventions": [ { "Name": "Blood samples, tumor biopsy specimens and ascites samples will be collected.", "Type": "OTHER", "Description": "Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice) for a maximum follow-up period of 5 years from baseline:\n\n* at Baseline.\n* at every surgical procedure or tumor biopsy.\n* every 6 months (± 2 months) (only blood sample).\n* at the time of the progression or recurrence, additional samples will be collected, and optionally at the time of the following progressions or recurrences (if applicable).\n\nFor patients undergoing a RT treatment, blood samples will be collected before the RT (i.e. at the time of planning CT-scan), at the last session of RT (± 2 days) and 3 months after the end of the RT (± 2 weeks).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03663725", "BriefTitle": "Treatment Intensification With Temozolomide in Adults With a Glioblastoma", "OfficialTitle": "Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2019-03-13", "PrimaryCompletionDate": "2027-02", "Interventions": [ { "Name": "Intensified protocol", "Type": "DRUG", "Description": "Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Stupp protocol", "Type": "DRUG", "Description": "RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Oscar Lambret", "LeadSponsorClass": "OTHER", "Collaborators": [ "Association de Neuro-Oncologues d'Expression Francaise", "Erasme University Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01547546", "BriefTitle": "A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma", "OfficialTitle": "An Open-label, Phase I, Dose-escalation Study Evaluating the Safety and Tolerability of GDC-0084 Administered to Patients With Progressive or Recurrent High-grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-04", "PrimaryCompletionDate": "2015-01", "Interventions": [ { "Name": "GDC-0084", "Type": "DRUG", "Description": "Multiple doses", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Genentech, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01317888", "BriefTitle": "Access Protocol for MAB-425 Radiolabeled With I-125 for High Grade Gliomas", "OfficialTitle": "An Access Protocol for Continued Use of Anti-Epidermal Growth Factor Receptor-425 (Anti-EGFr-425) Monoclonal Antibody Radiolabeled With 1-125 for High Grade Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2010-01", "PrimaryCompletionDate": "2014-01", "Interventions": [ { "Name": "MAB-425 radiolabeled with I-125", "Type": "DRUG", "Description": "MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Drexel University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT02780024", "BriefTitle": "Metformin, Neo-adjuvant Temozolomide and Hypo- Accelerated Radiotherapy Followed by Adjuvant TMZ in Patients With GBM", "OfficialTitle": "Metformin and Neo-adjuvant Temozolomide and Hypofractionated Accelerated Limited-margin Radiotherapy Followed by Adjuvant Temozolomide in Patients With Glioblastoma Multiforme (M-HARTT STUDY)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2015-03", "PrimaryCompletionDate": "2021-10-20", "Interventions": [ { "Name": "Metformin", "Type": "DRUG", "Description": "Metformin,", "OtherNames": [ "Glucophage" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "McGill University Health Centre/Research Institute of the McGill University Health Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05465954", "BriefTitle": "Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-01-24", "PrimaryCompletionDate": "2027-10-15", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Efineptakin alfa", "Type": "BIOLOGICAL", "Description": "Given IM", "OtherNames": [ "GX-I7", "Hyleukin-7 (TM)", "Il-7 Hybrid Fc", "IL-7-hyFc", "NT-I7", "rhIL-7-hyFc", "TJ 107", "TJ-107", "TJ107" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Biopsy", "Type": "PROCEDURE", "Description": "Undergo tumor biopsy", "OtherNames": [ "BIOPSY_TYPE", "Bx" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "NeoImmuneTech", "Merck Sharp & Dohme LLC", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT06455189", "BriefTitle": "Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas", "OfficialTitle": "Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-12", "PrimaryCompletionDate": "2029-06-01", "Interventions": [ { "Name": "Control Group - Standard of care neurosurgical resection", "Type": "OTHER", "Description": "The control group will include only standard of care tools. - Standard of care neurosurgical resection will include the use of all standard neurosurgical instruments and techniques (eg, microscope, intraoperative ultrasound, 5-ALA fluorescence guided surgery and neuronavigation system).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MRF/MRI infiltration guidance for extended resection", "Type": "PROCEDURE", "Description": "Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02926222", "BriefTitle": "Regorafenib in Relapsed Glioblastoma", "OfficialTitle": "Regorafenib in Relapsed Glioblastoma REGOMA Study Randomized, Controlled Open-label Phase II Clinical Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-11", "PrimaryCompletionDate": "2017-07", "Interventions": [ { "Name": "Regorafenib", "Type": "DRUG", "Description": "Regorafenib is formulated as tablets of 40mg for oral administration.", "OtherNames": [ "Stivarga" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Lomustine is formulated as tablets of 40mg for oral administration.", "OtherNames": [ "Ceenu" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Istituto Oncologico Veneto IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [ "BAYER S.p.A. - Italia" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02711137", "BriefTitle": "Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies", "OfficialTitle": "A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-05-18", "PrimaryCompletionDate": "2019-02-13", "Interventions": [ { "Name": "INCB057643", "Type": "DRUG", "Description": "Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gemcitabine", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Paclitaxel", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Rucaparib", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Abiraterone", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Ruxolitinib", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Azacitidine", "Type": "DRUG", "Description": "Standard of Care (SOC) agents", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Incyte Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT07193628", "BriefTitle": "B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma", "OfficialTitle": "An Open-label, First-in-human, Dose-escalation and Dose-expansion, Phase I Study of Fully Human B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy for Treatment of Recurrent or Refractory Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-09-26", "PrimaryCompletionDate": "2027-12-31", "Interventions": [ { "Name": "EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 1)", "Type": "BIOLOGICAL", "Description": "2.5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 2)", "Type": "BIOLOGICAL", "Description": "5 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 3)", "Type": "BIOLOGICAL", "Description": "10 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "EPC-003 Fully Human Anti-B7H3/IL13Ra2 Armored CAR-T Cell Therapy (Dose level 4)", "Type": "BIOLOGICAL", "Description": "20 × 10⁶ EPC-003 CAR-T cells will be administered into the Ommaya reservoir of the subjects weekly.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00075894", "BriefTitle": "Alanosine in Treating Patients With Progressive or Recurrent Malignant Gliomas", "OfficialTitle": "A Phase I/II, Open-Label, Non-Randomized, Multicenter, Single Agent Study Of Intravenous SDX-102 For The Treatment Of Patients With MTAP-Deficient High Grade Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-03", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "L-alanosine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00112619", "BriefTitle": "Topotecan in Treating Young Patients With Neoplastic Meningitis Due to Leukemia, Lymphoma, or Solid Tumors", "OfficialTitle": "A Phase I Pharmacokinetic Optimal Dosing Study of Intraventricular Topotecan for Children With Neoplastic Meningitis", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2005-08", "PrimaryCompletionDate": "2010-08", "Interventions": [ { "Name": "topotecan hydrochloride", "Type": "DRUG", "Description": "Participants receive intraventricular topotecan, .2 mg, administered via an indwelling ventricular reservoir daily for 5 consecutive days during weeks 1 and 3 of the first four weeks of therapy (induction), during weeks 5 and 8 of the next 6 weeks of therapy (consolidation), and during weeks 11, 15, 19, 23, 27, 31, 35, 39, 43, 47, and 51 (maintenance therapy).", "OtherNames": [ "Hycamptin" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03849105", "BriefTitle": "131I-IPA and Concurrent XRT in Recurrent GBM", "OfficialTitle": "A Multi-centre, Open-label, Single-arm, Dose-finding Phase I/II Study to Evaluate Safety, Tolerability, Dosing Schedule, and Preliminary Efficacy of Carrier-added 4-L-[131I]Iodo-phenylalanine (131I-IPA), Administered as Single or Repetitive Injections in Patients With Recurrent Glioblastoma Multiforme (GBM), Concomitantly to 2nd Line External Radiation Therapy (XRT) - IPAX- 1", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-04-09", "PrimaryCompletionDate": "2022-07-31", "Interventions": [ { "Name": "4-L-[131I]iodo-phenylalanine (131I-IPA)", "Type": "RADIATION", "Description": "Study participants will receive by intravenous infusion an escalating activity of 4-L-\\[131I\\]iodo-phenylalanine (131I-IPA).\n\nAdditional therapy is received in the form of externally administered radiotherapy", "OtherNames": [ "external radiotherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Telix Pharmaceuticals (Innovations) Pty Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03927222", "BriefTitle": "Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma", "OfficialTitle": "I-ATTAC: Improved Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2019-09-30", "PrimaryCompletionDate": "2023-02-10", "Interventions": [ { "Name": "Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF", "Type": "BIOLOGICAL", "Description": "2x10\\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.", "OtherNames": [ "CMV-specific dendritic cell vaccine", "DCs" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is a chemotherapy drug given to all enrolled patients at the post-RT clinic visit as dose-intensified TMZ (100 mg/m2/day for 21 days).", "OtherNames": [ "Temodar", "TMZ", "Temodal" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Tetanus-Diphtheria Toxoid (Td)", "Type": "BIOLOGICAL", "Description": "Before the first DC vaccination, patients will receive 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Prior to pp65 DC vaccination #4,(3±1) weeks after leukapheresis 2 the vaccine site will receive a pre-conditioning intradermal injection of Td (1 flocculation unit (Lf), in 0.3 mL of saline for a total of 0.4 mL).", "OtherNames": [ "Td pre-conditioning", "Td toxoid" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "GM-CSF", "Type": "BIOLOGICAL", "Description": "Granulocyte macrophage-colony stimulating factor (GM-CSF) is a sterile, white, preservative-free lyophilized powder in a vial containing 250 mcg that will be reconstituted in 0.5 mL of sterile water for injection and used as an adjuvant with the DC vaccine.", "OtherNames": [ "LEUKINE®", "Sargramostim" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "111-Indium-labeling of Cells for in vivo Trafficking Studies", "Type": "BIOLOGICAL", "Description": "111-In-labeled DCs are 2 x 10\\^7 pp65-LAMP mRNA loaded mature DCs labeled with 111-In (50 μCi / 5 x 10\\^7 DCs) and given i.d. as the fourth vaccine. In up to 16 patients, the fourth vaccine will be labeled with 111-In (50 μCi / 5 x 10\\^7 DCs) prior to injection.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Mustafa Khasraw, MBChB, MD, FRCP, FRACP", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01339039", "BriefTitle": "Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma", "OfficialTitle": "Phase I Study of Plerixafor (AMD3100) and Bevacizumab for Recurrent High-Grade Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2014-04", "Interventions": [ { "Name": "Plerixafor", "Type": "DRUG", "Description": "Given subcutaneously once a day for 3 weeks followed by 1 week off (standard 3x3 design); MTD determined in Part 1 will be used as dose in Part 2.", "OtherNames": [ "AMD3100", "Mozobil" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Plerixafor", "Type": "DRUG", "Description": "Given subcutaneously once daily; MTD determined in Part 1 will be used as dose in Part 3.", "OtherNames": [ "AMD3100", "Mozobil" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Given intravenously on days 1 and 15 (10 mg/kg) of each 28-day cycle", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Plerixafor", "Type": "DRUG", "Description": "Daily administration for 5-9 days prior to surgery", "OtherNames": [ "AMD3100", "Mozobil" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "After receiving 5-9 days of Plerixafor (AMD3100) monotherapy, patients proceed to surgery. After recovering from surgery, patients will proceed to 28-day post-surgical cycles of therapy (Plerixafor at the MTD established in Part 1, 21 days on / 7 days off; bevacizumab 10 mg/kg on days 1 \\& 15).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Patrick Y. Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dana-Farber Cancer Institute", "Brigham and Women's Hospital", "Massachusetts General Hospital", "Genzyme, a Sanofi Company" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05182905", "BriefTitle": "AZD1390 in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients", "OfficialTitle": "A Phase 0/1b, Single Center, Clinical Trial With an Expansion Phase of AZD1390 Plus Fractionated Radiotherapy in Recurrent and Newly Diagnosed WHO Grade 4 Glioma Patients", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-03-09", "PrimaryCompletionDate": "2025-09", "Interventions": [ { "Name": "AZD1390", "Type": "DRUG", "Description": "Phase 0: AZD1390 administered orally daily for 3 days prior to resection\n\nPhase 1b: AZD1390 administered daily for 5 days concurrently with standard of care radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Institute", "Ivy Brain Tumor Center", "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05653622", "BriefTitle": "Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma", "OfficialTitle": "Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-06-23", "PrimaryCompletionDate": "2028-07-01", "Interventions": [ { "Name": "Integrated boost technique (SIB) guided by PET FDOPA", "Type": "PROCEDURE", "Description": "intensity-modulated irradiation scheme with integrated boost technique (SIB) guided by PET FDOPA during the chemo-radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut de cancérologie Strasbourg Europe", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06815029", "BriefTitle": "Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma", "OfficialTitle": "A Phase 1 Trial to Evaluate the Safety of IL13Rα2-Targeting Chimeric Antigen Receptor (CAR) T Cells With CRISPR Knockout of TGFβR2 in Patients With Recurrent or Progressive High-Grade Glioma (HGG)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-06-17", "PrimaryCompletionDate": "2030-10-11", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo CSF and blood sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Chimeric Antigen Receptor T-Cell Therapy", "Type": "BIOLOGICAL", "Description": "Given autologous TGF-betaR2KO/IL13R-alpha2-CAR T cells intracranially", "OtherNames": [ "CAR T Infusion", "CAR T Therapy", "CAR T-cell Therapy", "Chimeric Antigen Receptor T-cell Infusion" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Echocardiography", "Type": "PROCEDURE", "Description": "Undergo echocardiography", "OtherNames": [ "EC" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Fludeoxyglucose F-18", "Type": "OTHER", "Description": "Undergo FDG-PET", "OtherNames": [ "18FDG", "FDG", "Fludeoxyglucose (18F)", "fludeoxyglucose F 18", "Fludeoxyglucose F18", "Fluorine-18 2-Fluoro-2-deoxy-D-Glucose", "Fluorodeoxyglucose F18" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Intracranial Catheter Placement", "Type": "PROCEDURE", "Description": "Undergo placement of Rickham catheter", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Leukapheresis", "Type": "PROCEDURE", "Description": "Undergo leukapheresis", "OtherNames": [ "Leukocyte Adsorptive Apheresis", "Leukocytopheresis", "Therapeutic Leukopheresis", "White Blood Cell Reduction Apheresis" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo FDG-PET", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron emission tomography (procedure)", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging", "PT" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Surgical Resection" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT03310372", "BriefTitle": "Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme", "OfficialTitle": "Phase II Clinical Trial of Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-02-13", "PrimaryCompletionDate": "2012-06-26", "Interventions": [ { "Name": "Ultrafractionated brain irradiation", "Type": "RADIATION", "Description": "0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)", "OtherNames": [ "Temodal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Central Hospital, Nancy, France", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02366728", "BriefTitle": "DC Migration Study for Newly-Diagnosed GBM", "OfficialTitle": "Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant TEtanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-10-12", "PrimaryCompletionDate": "2020-10-31", "Interventions": [ { "Name": "Unpulsed DCs", "Type": "BIOLOGICAL", "Description": "Patients in Group I will receive 1 x 10\\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.", "OtherNames": [ "Unpulsed DCs pre-conditioning" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Td", "Type": "BIOLOGICAL", "Description": "Patients in Groups II and III will receive a single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally 1 day before the fourth vaccine.", "OtherNames": [ "Td toxoid", "Td pre-conditioning" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Human CMV pp65-LAMP mRNA-pulsed autologous DCs", "Type": "BIOLOGICAL", "Description": "2x10\\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.", "OtherNames": [ "CMV-specific dendritic cell vaccine", "DCs" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "111In-labeled DCs", "Type": "BIOLOGICAL", "Description": "111In-labeled DCs are 2 x 10\\^7 pp65-LAMP mRNA loaded mature DCs will be labeled with 111In (50 μCi / 5 x 10\\^7 DCs) and given i.d. as fourth vaccine for Groups I and II only.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 5 (± 1) weeks for a total of 6 to 12 cycles at the discretion of the treating oncologist.", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Saline", "Type": "DRUG", "Description": "0.4mL of saline given in the opposite groin 1 day before the fourth vaccine in all groups", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Basiliximab", "Type": "DRUG", "Description": "Group III will receive basiliximab infusions (20 mg I.V) 1 week before the first vaccine and 1 week before the second vaccine.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mustafa Khasraw, MBChB, MD, FRCP, FRACP", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00784914", "BriefTitle": "A Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors", "OfficialTitle": "A Pilot Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-06", "PrimaryCompletionDate": "2010-11", "Interventions": [ { "Name": "temsirolimus", "Type": "DRUG", "Description": "Receive temsirolimus IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Plasma levels of temsirolimus and sirolimus will be evaluated in serial blood samples.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [] } }, { "Name": "cytokine levels", "Type": "OTHER", "Description": "Dialysate samples are collected at regular intervals during the 96 hours following placement of the catheter to measure changes in levels of cytokines, chemokines and growth factors", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "mTOR" ], "classes": [] } }, { "NCTId": "NCT06614855", "BriefTitle": "A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-06-02", "PrimaryCompletionDate": "2027-01-01", "Interventions": [ { "Name": "C134", "Type": "DRUG", "Description": "Initial Treatment . C134 Dose #1", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "C134", "Type": "DRUG", "Description": "2nd Treatment. C134 Dose #2", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "James Markert, MD", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00071539", "BriefTitle": "Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-10", "PrimaryCompletionDate": "2006-01", "Interventions": [ { "Name": "TP-38", "Type": "DRUG", "Description": "Recombinant chimeric protein", "OtherNames": [ "immunotoxin" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "TP38", "Type": "DRUG", "Description": "recombinant chimeric protein", "OtherNames": [ "immunotoxin" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Teva Branded Pharmaceutical Products R&D, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00735436", "BriefTitle": "A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM)", "OfficialTitle": "Phase II Trial for Patients With Glioblastoma Multiforme (GBM) Treated With Gliadel Followed by Avastin Plus Irinotecan", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2008-12", "PrimaryCompletionDate": "2011-07", "Interventions": [ { "Name": "Gliadel/Avastin/CPT-11", "Type": "DRUG", "Description": null, "OtherNames": [ "bevacizumab", "irinotecan" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Eisai Inc.", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03615404", "BriefTitle": "Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma", "OfficialTitle": "A Phase 1 Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-10-05", "PrimaryCompletionDate": "2019-11-19", "Interventions": [ { "Name": "CMV-DCs with GM-CSF", "Type": "BIOLOGICAL", "Description": "CMV-DCs are autologous dendritic cells derived from PBMCs loaded with RNA encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF.", "OtherNames": [ "pp65-flLAMP DC with GM-CSF" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Td (tetanus toxoid)", "Type": "BIOLOGICAL", "Description": "Patients will receive preconditioning with Td in the right groin, and approximately 6-24 hours later, they will receive their first CMV-DC vaccination. Patients will also receive Td preconditioning approximately 6-24 hours prior to their 4th vaccine and subsequent vaccines, if any.", "OtherNames": [ "Tetanus and Diphtheria Toxoid" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Gary Archer Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02630030", "BriefTitle": "Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma", "OfficialTitle": "Phase 0 Analysis of Ixazomib (MLN9708) in Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2016-03-24", "PrimaryCompletionDate": "2018-07-01", "Interventions": [ { "Name": "Ixazomib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "MLN9708" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Takeda" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01301430", "BriefTitle": "Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.", "OfficialTitle": "Phase I/IIa Study of Intratumoral/Intracerebral or Intravenous/Intracerebral Administration of Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-09", "PrimaryCompletionDate": "2015-05", "Interventions": [ { "Name": "H-1PV", "Type": "DRUG", "Description": "H-1PV administered at three increasing doses either intratumorally or intravenously and then 10 days after the first administration intracerebrally (into the walls of tumor resection cavity).", "OtherNames": [ "ParvOryx (brand name of H-1PV)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oryx GmbH & Co. KG", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03636477", "BriefTitle": "A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102", "OfficialTitle": "Protocol ATI001-102 Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Combination With Nivolumab in Subjects With Recurrent or Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-06-18", "PrimaryCompletionDate": "2020-10-15", "Interventions": [ { "Name": "Ad-RTS-hIL-12", "Type": "BIOLOGICAL", "Description": "* 2.0 x 10\\^11 viral particles (vp) per injection\n* intratumoral injection of Ad-RTS-hIL-12", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "veledimex", "Type": "DRUG", "Description": "* 2 doses (10mg/day, 20mg/day)\n* 15 oral daily doses of veledimex", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "* 2 doses (1mg/kg, 3mg/kg)\n* Every 2 weeks", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Alaunos Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT00390299", "BriefTitle": "Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I Trial of a Measles Virus Derivative Producing CEA (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-10-23", "PrimaryCompletionDate": "2018-11-29", "Interventions": [ { "Name": "Carcinoembryonic Antigen-Expressing Measles Virus", "Type": "BIOLOGICAL", "Description": "Given via injection into resection cavity or around tumor bed and/or IT", "OtherNames": [ "MV-CEA" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo en bloc resection", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02025231", "BriefTitle": "Image Guided Reirradiation of High-grade Glioma", "OfficialTitle": "Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2015-04", "Interventions": [ { "Name": "External beam radiotherapy", "Type": "RADIATION", "Description": "Study group 1: 3.5 Gray x 10, 5 fractions per week. Study group 2: 3.5 Gray x 10 + 7 Gray boost to biological target volume, 5 fractions per week. Study group 3: 5.9 Gray x 10, 5 fractions per week. Study group 4 (planning target volumes: 100 millilitres - 300 millilitres): 3.5 Gray x 10, 5 fractions per week. Phase II dosis: to be chosen based on results of phase I study.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rigshospitalet, Denmark", "LeadSponsorClass": "OTHER", "Collaborators": [ "Danish Center for Interventional Research in Radiation Oncology (CIRRO)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03618667", "BriefTitle": "GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification", "OfficialTitle": "A Phase II Clinical Study of GC1118 in Recurrent Glioblastoma Patients With High Epidermal Growth Factor Receptor (EGFR) Amplification", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-01-22", "PrimaryCompletionDate": "2018-09-08", "Interventions": [ { "Name": "GC1118", "Type": "DRUG", "Description": "GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Samsung Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00006773", "BriefTitle": "Bortezomib in Treating Patients With Recurrent Glioma", "OfficialTitle": "Phase I Evaluation of the Safety of PS 341 in the Treatment of Recurrent Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2001-05", "PrimaryCompletionDate": "2007-06", "Interventions": [ { "Name": "bortezomib", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "LDP 341", "MLN341", "VELCADE" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03718767", "BriefTitle": "Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype", "OfficialTitle": "Phase II Trial Evaluating Nivolumab In Patients With IDH-Mutant Gliomas With And Without Hypermutator Phenotype", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2019-03-27", "PrimaryCompletionDate": "2024-11-05", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Intravenous (IV) Nivolumab", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "IDH", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "IDH", "PD-1" ], "classes": [] } }, { "NCTId": "NCT00335764", "BriefTitle": "Sorafenib Combined With Erlotinib, Tipifarnib, or Temsirolimus in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase I/II Studies of BAY 43-9006 (Sorafenib) in Combination With OSI-774 (Erlotinib), R115777 (Tipifarnib) or CCI-779 (Temsirolimus) in Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-04", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "sorafenib tosylate", "Type": "DRUG", "Description": "given orally", "OtherNames": [ "BAY 43-9006", "BAY 43-9006 Tosylate Salt", "BAY 54-9085", "Nexavar", "SFN" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "given orally", "OtherNames": [ "CP-358,774", "erlotinib", "OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "tipifarnib", "Type": "DRUG", "Description": "given orally", "OtherNames": [ "R115777", "Zarnestra" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "temsirolimus", "Type": "DRUG", "Description": "IV administration", "OtherNames": [ "CCI-779", "cell cycle inhibitor 779", "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT04765098", "BriefTitle": "Tamoxifen Versus Etoposide After First Recurrence in GBM Patients", "OfficialTitle": "A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-01-28", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Tamoxifen", "Type": "DRUG", "Description": "Tamoxifen 20 mg daily for 3 days then 20 mg BID for 3 days then increase by 20 mg daily every 3 days until 100 mg BID continuously", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Etoposide", "Type": "DRUG", "Description": "etoposide 50mg/m2 daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00002463", "BriefTitle": "Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors", "OfficialTitle": "Phase II Study of Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP) as Primary Therapy in Infants or Young Children With Primitive Neuroectodermal Tumors or High-Grade Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1989-02", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "MOPP Regimen", "Type": "DRUG", "Description": "Methotrexate, Mechlorethamine, Vincristine, Prednisone, and Procarbazine (MMOPP)", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Leucovorin Calcium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Mechlorethamine Hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Methotrexate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Prednisone", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Procarbazine Hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Vincristine Sulfate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Conventional Surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04521686", "BriefTitle": "Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations", "OfficialTitle": "A Phase 1 Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-10-01", "PrimaryCompletionDate": "2023-07-17", "Interventions": [ { "Name": "LY3410738", "Type": "DRUG", "Description": "Oral LY3410738", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Gemcitabine", "Type": "DRUG", "Description": "Intravenous gemcitabine", "OtherNames": [ "LY188011" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Cisplatin", "Type": "DRUG", "Description": "Intravenous cisplatin", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Durvalumab", "Type": "DRUG", "Description": "Intravenous durvalumab", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH", "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "PD-L1" ], "classes": [] } }, { "NCTId": "NCT00508456", "BriefTitle": "Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM", "OfficialTitle": "A Phase I Study of Dietary Methionine Restriction and Temodar® (Temozolomide) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2004-08", "PrimaryCompletionDate": "2008-11", "Interventions": [ { "Name": "Temodar (Temozolomide)", "Type": "DRUG", "Description": "150 mg/m\\^2 orally once a day for 7 consecutive days (days 8 through 15).", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Hominex-2", "Type": "DIETARY_SUPPLEMENT", "Description": "Methionine free diet during Days 1 - 7 and Days 15 - 21 by consuming only \"shakes\" containing Hominex-2®.", "OtherNames": [ "Hominex-2® shakes", "Methionine restriction diet", "Hominex®-2 Amino Acid-Modified Medical Food" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02876003", "BriefTitle": "Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma", "OfficialTitle": "An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy, Safety and CNS Exposure of G-202 in Patients With PSMA Positive Recurrent or Progressive Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2016-09", "PrimaryCompletionDate": "2019-10", "Interventions": [ { "Name": "G-202", "Type": "DRUG", "Description": "G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity", "OtherNames": [ "Mipsagargin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "GenSpera, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Saint John's Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00805961", "BriefTitle": "RT, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in First-line Treatment of GBM", "OfficialTitle": "A Phase II Study of Concurrent Radiation Therapy, Temozolomide, and Bevacizumab Followed by Bevacizumab/Everolimus in the First-line of Treatment of Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-01", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Radiation therapy, 2.0 Gy daily, 5 days per week by single daily dose, to a total of 60 Gy over 6 weeks", "OtherNames": [ "Combined Modality Treatment" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide 75mg/m2 by mouth daily, beginning day 1 of radiation therapy and continuing through the last day of radiation therapy", "OtherNames": [ "Combined Modality Treatment" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab 10mg/kg IV, every 2 weeks, beginning day 1 of radiation therapy", "OtherNames": [ "Combined Modality Treatment" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab 10mg/kg IV, every 2 weeks, beginning Week 11", "OtherNames": [ "Systemic Therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "Everolimus 10mg by mouth daily, beginning Week 11", "OtherNames": [ "Systemic Therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "SCRI Development Innovations, LLC", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00337883", "BriefTitle": "A Study of the Safety and Efficacy of Tarceva in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)", "OfficialTitle": "A Phase II, Multicenter, Open-Label Trial of the Safety and Efficacy of Tarceva (Erlotinib Hydrochloride) in Patients With First Relapse of Grade IV Glioma (Glioblastoma Multiforme)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Erlotinib HCl (OSI-774)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Genentech, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00751270", "BriefTitle": "Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas", "OfficialTitle": "A Phase 1b Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-11", "PrimaryCompletionDate": "2010-01", "Interventions": [ { "Name": "AdV-tk", "Type": "BIOLOGICAL", "Description": "Three different dosing levels of AdV-tk (3x10e10, 1x10e11, 3X10e11) were evaluated. A single injection of AdV-tk at the assigned dose level was administered, followed by 14 days of the oral prodrug valacyclovir. Patients then received standard of care radiation therapy and chemotherapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Valacyclovir", "Type": "DRUG", "Description": "The oral prodrug valacyclovir was given beginning 1-3 days following the AdV-tk. Valacyclovir tablets were taken three times a day for a total of 14 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Candel Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03780569", "BriefTitle": "TTFields Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM", "OfficialTitle": "A Prospective Trial of NovoTTF-200A Together With Temozolomide and Radiotherapy in Patients With Newly Diagnosed GBM", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2017-04-27", "PrimaryCompletionDate": "2019-01", "Interventions": [ { "Name": "NovoTTF-200A", "Type": "DEVICE", "Description": "Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "60Gy given in 30 2Gy fractions concomitant to temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide(TMZ) will be administered at 75 mg/m\\^2 concomitant to radiotherapy(RT) and NovoTTF-200A.\n\nMaintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m\\^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m\\^2 in the absence of toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NovoCure Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02337686", "BriefTitle": "Pembrolizumab in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Pharmacodynamic Study of Pembrolizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2015-04-28", "PrimaryCompletionDate": "2017-05-24", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT03717142", "BriefTitle": "Feasibility of the LUM Imaging System for Detection of Cancer to the Brain", "OfficialTitle": "Feasibility of the LUM Imaging System for in Vivo and Ex Vivo Detection of Cancer in Subjects with Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2019-05-03", "PrimaryCompletionDate": "2023-09-13", "Interventions": [ { "Name": "LUM Imaging System", "Type": "COMBINATION_PRODUCT", "Description": "Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Lumicell, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06061809", "BriefTitle": "N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma", "OfficialTitle": "Open-Label, Single-Arm Phase 2 Study of Nogapendekin Alfa Inbakicept, PD-L1 t-haNK, Bevacizumab and Randomized Phase 2B Study of Nogapendekin Alfa Inbakicept, Bevacizumab, and Tumor Treatment Fields With or Without PD-L1 t-haNK in Participants With Recurrent or Progressive Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-08-07", "PrimaryCompletionDate": "2029-12-31", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Participants will receive 10mg/kg of Bevacizumab intravenously (IV) on Day 1 and Day 15 of each repeated cycle of treatment.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "PD-L1 t-haNK", "Type": "DRUG", "Description": "Participants will receive PD-L1 t-haNK (\\~2 × 109 cells/infusion) intravenously (IV) on Day 1 and Day 15 of each repeated cycle of treatment.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "N-803", "Type": "DRUG", "Description": "Participants will receive 1mg subcutaneously (SC) on Day 1 and Day 15 of each repeated cycle of treatment.", "OtherNames": [ "ALT-803", "Anktiva" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Tumor Treating Fields (TTFields, 200 kHz)", "Type": "DEVICE", "Description": "TTFields (OPTUNE Gio®), for the treatment of newly diagnosed and/or recurrent GBM, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields (\"TTFields\") within the human body/brain. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells. TTFields is comprised of two main components: (1) an Electric Field Generator and (2) INE Insulated Transducer Arrays (the transducer arrays). Patients carry the device in an over-the-shoulder bag or backpack and receive continuous treatment without changing their daily routine.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "ImmunityBio, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03712293", "BriefTitle": "ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy", "OfficialTitle": "Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of Glioblastoma in Patients Undergoing Standard Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2018-08-28", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "BBB Disruption with Chemotherapy Arm", "Type": "DEVICE", "Description": "The ExAblate BBB disruption of targets associated with enhancing post-resection MRI imaging procedure will be performed with ExAblate 4000 type 2.0 system and will coincide with on one of three first days of each planned TMZ adjuvant therapy cycle as one procedure per cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02014844", "BriefTitle": "Phase 2 Study to Investigate the Efficacy and Safety of Aldoxorubicin in Subjects With Glioblastoma", "OfficialTitle": "An Open-Label Pilot Phase 2 Study to Investigate the Preliminary Efficacy and Safety of Aldoxorubicin in Subjects With Unresectable Glioblastoma Whose Tumors Have Progressed Following Prior Treatment With Surgery, Radiation and Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-03", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "250 mg/m2 aldoxorubicin", "Type": "DRUG", "Description": null, "OtherNames": [ "INNO-206" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "350 mg/m2 aldoxorubicin", "Type": "DRUG", "Description": null, "OtherNames": [ "INNO-206" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "ImmunityBio, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02038699", "BriefTitle": "A First-in-man Phase I/II Study of Oral ONC201 in Patients With Advanced Cancer", "OfficialTitle": "A First-in-man Phase I/II Single-agent Open-label Dose-escalation Study of Every Three-week Dosing of Oral ONC201 in Patients With Advanced Cancer and Limited Treatment Options", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "ONC201", "Type": "DRUG", "Description": "ONC201 capsules will be administered orally once every three weeks with flat dosing. Dosage will be given according to a modified Fibonacci sequence with the anticipated starting dose being 125 mg.", "OtherNames": [ "TIC10" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jazz Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01290263", "BriefTitle": "Amgen 386 for Recurrent Glioblastoma", "OfficialTitle": "Phase I/II Study of Amgen 386 With and Without Bevacizumab for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2015-07", "Interventions": [ { "Name": "Amgen 386", "Type": "DRUG", "Description": "For Cohort A, AMG 386 will be administered intravenously at 30 mg/kg every week.\n\nFor Cohort B Phase I, AMG 386 will be administered intravenously at beginning at starting dose level of 15 mg/kg every week.\n\nFor Cohort B Phase II, AMG 386 will be administered intravenously at the maximum tolerated dose determined in the Phase I portion of the study every week.", "OtherNames": [ "Trebananib" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "The dose of bevacizumab will be 10 mg/kg and will be administered intravenously every other week.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Amgen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT07218367", "BriefTitle": "Phase I Trial of pH Resections of GBM at VA", "OfficialTitle": "Targeting Infiltrating Glioblastoma Via pH Sensitive Visualization of Tumor and pH Modulation Through Bicarbonate Transporter SLC4A4", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2026-02-01", "PrimaryCompletionDate": "2031-02-01", "Interventions": [ { "Name": "pH MRI based resection of GBM", "Type": "PROCEDURE", "Description": "This will require a chemical exchange saturation transfer MRI followed by surgical resection based on this MRI.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "VA Office of Research and Development", "LeadSponsorClass": "FED", "Collaborators": [ "University of California, Los Angeles" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01149109", "BriefTitle": "Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients", "OfficialTitle": "Phase III Trial of CCNU/Temozolomide (TMZ) Combination Therapy vs. Standard TMZ Therapy for Newly Diagnosed MGMT-methylated Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2017-04-06", "Interventions": [ { "Name": "Temozolomide and lomustine", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodal, Temomedac, CeCeNu" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodal, Temomedac" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital, Bonn", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05131711", "BriefTitle": "Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)", "OfficialTitle": "Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas (inSituVac2)(CSREIG)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-11-16", "PrimaryCompletionDate": "2022-11-16", "Interventions": [ { "Name": "Combined stereotactic radiosurgery and enhanced immunotherapy", "Type": "COMBINATION_PRODUCT", "Description": "Patients will be administrated immunal adjuvants intratumorally and systemically with concurrent stereotactic radiosurgery.", "OtherNames": [ "stereotactic radiosurgery and GM-CSF, Sapylin, MnCl2" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04091503", "BriefTitle": "Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma", "OfficialTitle": "Pilot Study to Evaluate the Safety, Tolerability and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma (Phase I)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2019-12-20", "PrimaryCompletionDate": "2022-09-21", "Interventions": [ { "Name": "Intranasal Modified Temozolomide", "Type": "DRUG", "Description": "Intranasally Modified Temozolomide is administered to patients at a dose of 75/150/200 mg / M2 for five days continuously. After the 5-day course, patients do not take treatment for two days, and they will be examined on an outpatient basis (blood tests, kidney and liver tests, visually mucous membranes of the mouth, nasal cavity, olfactory rapid tests, including the University of Pennsylvania test, etc.).\n\nAfter 30 days after the first intranasal administration of Modified Temozolomide (IM-TMZ), all patients undergo an MRI of the brain with perfusion and ultrasound of the abdominal cavity as an outpatient, after which the results are evaluated", "OtherNames": [ "Temozolomide", "TMZ", "IM-TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Center Trials & Treatment Europe", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00431561", "BriefTitle": "Phase IIb Clinical Trial With TGF-β2 Antisense Compound AP 12009 for Recurrent or Refractory High-grade Glioma", "OfficialTitle": "Multi-national, Open-label, Active-controlled, Randomized Dose-finding Study to Evaluate Efficacy of 2 Doses of AP 12009 in Recurrent Glioma, Administered Intratumorally as Continuous High-flow Microperfusion Over 7 Days Every Other Week", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-04", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "AP 12009 10 µM", "Type": "DRUG", "Description": "10 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks", "OtherNames": [], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "AP 12009 80 µM", "Type": "DRUG", "Description": "80 µM AP 12009 (trabedersen), intratumoral infusion, every other week, 11 cycles, maximum 21 weeks", "OtherNames": [], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "temozolomide or PCV", "Type": "DRUG", "Description": "temozolomide: capsules, up to 200 mg/sqm/day, 5 days per cycle; PCV (procarbazine, CCNU, vincristine): standard regimen", "OtherNames": [ "Temodar", "Temodal", "TMZ", "lomustine", "Cecenu", "CeeNU" ], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Drug delivery system for administration of AP 12009", "Type": "DEVICE", "Description": "Drug delivery system for Convection Enhanced Delivery consists of a portable pump with drug reservoir and infusion line. Main implanted parts are the port access system and the intratumoral catheter.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placement of Drug Delivery System", "Type": "PROCEDURE", "Description": "Surgery for placement of intratumoral catheter and subcutaneous port access system as per routine clinical practice. Stereotactical catheter placement controlled by CT.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Isarna Therapeutics GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04391062", "BriefTitle": "Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma", "OfficialTitle": "A Multi-center Phase II Study With Light Dose Escalation During Intraoperative Photodynamic Therapy of Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2021-09-28", "PrimaryCompletionDate": "2024-03-25", "Interventions": [ { "Name": "Gliolan", "Type": "DRUG", "Description": "patient will receive 5-ALA 4 to 6 hours before surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intraoperative PDT", "Type": "DEVICE", "Description": "The protocol requires the realization of specific procedures in addition to the usual care.\n\nThe intra-operative photodynamic therapy (\"intraoperative PDT\") added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital, Lille", "LeadSponsorClass": "OTHER", "Collaborators": [ "Institut National de la Santé Et de la Recherche Médicale, France", "Hemerion Therapeutics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00024570", "BriefTitle": "Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma", "OfficialTitle": "Interstitial Infusion of IL13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-11", "PrimaryCompletionDate": "2007-07", "Interventions": [ { "Name": "IL13-PE38QQR", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "targeted fusion protein therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01430351", "BriefTitle": "Temozolomide, Memantine Hydrochloride, Mefloquine, and Metformin Hydrochloride in Treating Patients With Glioblastoma Multiforme After Radiation Therapy", "OfficialTitle": "A Phase I Lead-In to a 2x2x2 Factorial Trial of Temozolomide, Memantine, Mefloquine, and Metformin as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-09-14", "PrimaryCompletionDate": "2025-02-02", "Interventions": [ { "Name": "Mefloquine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Memantine Hydrochloride", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Ebixia", "Namenda" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Metformin Hydrochloride", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "APO-Metformin", "Cidophage", "Dimefor", "Glifage", "Glucoformin", "Glucophage", "Glucophage ER", "Metformin HCl", "Riomet", "Siofor" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02717962", "BriefTitle": "Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting", "OfficialTitle": "Phase 2 Study of VAL-083 Treatment for MGMT Unmethylated Bevacizumab-naïve Glioblastoma in the Adjuvant or Recurrent Setting", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-01-20", "PrimaryCompletionDate": "2024-12-30", "Interventions": [ { "Name": "VAL-083, Dianhydrogalactitol", "Type": "DRUG", "Description": "The dosing regimen for patients will be VAL-083 (30 mg/m2) administered IV for 3 consecutive days at the beginning of every 21-day cycle. Patients will continue to receive VAL 083, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Kintara Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00905060", "BriefTitle": "HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM", "OfficialTitle": "PHASE 2, Multi-center, Single Arm Investigation of HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-06-29", "PrimaryCompletionDate": "2014-06-03", "Interventions": [ { "Name": "HSPPC-96", "Type": "BIOLOGICAL", "Description": "Autologous tumor-derived heat shock protein peptide-complex (HSPPC-96) administered at 25 μg per dose injected intradermally once weekly for 4 consecutive weeks and monthly following standard treatment with radiation and temozolomide.", "OtherNames": [ "Heat Shock", "Vitespen" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Maintenance temozolomide treatment is given 2 weeks after administration of the fourth vaccine at an initial dose of 150 mg per square meter (mg/m2) for 5 consecutive days in a 28-day cycle. The dose was increased to 200 mg/m2 for 5 days in subsequent cycles.", "OtherNames": [ "Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard Surgical Resection", "Type": "PROCEDURE", "Description": "Patients will undergo standard surgical resection of intracranial tumor", "OtherNames": [ "Craniotomy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "Agenus Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04838782", "BriefTitle": "Role of Repeat Resection in Recurrent Glioblastoma", "OfficialTitle": "Role of Repeat Resection in Recurrent Glioblastoma (4rGBM) Trial: a Randomized Care Trial for Patients With Recurrent GBM", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2021-08-26", "PrimaryCompletionDate": "2025-03-24", "Interventions": [ { "Name": "Repeat Surgical Management of Recurrent GBM", "Type": "PROCEDURE", "Description": "Routine of surgical operative management. Details of treatment will be left to local centers, and recorded in the case report form (CRF).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02573324", "BriefTitle": "A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification", "OfficialTitle": "A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2015-01-04", "PrimaryCompletionDate": "2022-04-04", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Oral Capsule", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Depatuxizumab mafodotin", "Type": "DRUG", "Description": "Intravenous (IV) Infusion", "OtherNames": [ "ABT-414" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo for ABT-414", "Type": "DRUG", "Description": "IV Infusion (IV)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Radiation Therapy Oncology Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06090903", "BriefTitle": "Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma", "OfficialTitle": "Exploration Into the Association Between Decorin (DCN) Expression and MR Phenotypes in GBM", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-04-14", "PrimaryCompletionDate": "2027-04-18", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "patients will receive 1-3 image-guided biopsies within tumor tissue already designated for resection or removal.", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI scan", "OtherNames": [ "Magnetic Resonance", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Medical Chart Review", "Type": "OTHER", "Description": "Review Medical Chart", "OtherNames": [ "Chart Review" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SCREENING", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00501891", "BriefTitle": "Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma", "OfficialTitle": "A Phase II Study of Bevacizumab in Combination With Metronomic Temozolomide for Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-07", "PrimaryCompletionDate": "2007-12", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab administered intravenously 10mg/kg every other week.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Metronomic Temozolomide", "Type": "DRUG", "Description": "Temozolomide 50mg/m2 given orally on a daily basis.", "OtherNames": [ "Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05927610", "BriefTitle": "Genetic Testing of Cerebrospinal Fluid to Diagnose and Monitor Glioblastoma", "OfficialTitle": "Evaluating the Role of Cerebrospinal Fluid (CSF) Cell-free DNA (cfDNA) as a Prognostic Biomarker in Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2023-06-19", "PrimaryCompletionDate": "2024-02-15", "Interventions": [ { "Name": "Lumber Puncture", "Type": "DIAGNOSTIC_TEST", "Description": "During the lumbar puncture/LP, 20cc will be collected per standard practice in adult patients. LP will be performed either at bedside or under interventional radiology (IR) guidance (due to patient anatomy).", "OtherNames": [ "LP" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04630379", "BriefTitle": "Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers", "OfficialTitle": "Pilot Study of Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2018-06-13", "PrimaryCompletionDate": "2019-06-13", "Interventions": [ { "Name": "Palliative Therapy", "Type": "OTHER", "Description": "Visit with palliative care team", "OtherNames": [ "Comfort Care", "PA-Palliative Therapy", "palliation", "Palliative", "Palliative Care", "Palliative Treatment", "Symptom Management", "Symptoms Management" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Supportive Care", "Type": "OTHER", "Description": "Visit with neuro-oncologist", "OtherNames": [ "Supportive Therapy", "Symptom Management", "Therapy, Supportive" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Survey Administration", "Type": "OTHER", "Description": "Complete survey", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00036660", "BriefTitle": "SarCNU in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-01-10", "PrimaryCompletionDate": "2003-04-15", "Interventions": [ { "Name": "SarCNU", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NCIC Clinical Trials Group", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004017", "BriefTitle": "Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma", "OfficialTitle": "Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 131 monoclonal antibody TNT-1/B", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Peregrine Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04967690", "BriefTitle": "A Dose Escalation Study to Estimate MTD, DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed GBM", "OfficialTitle": "An Open-label Dose Escalation Study to Estimate MTD, Identify DLTs and Study Pharmacokinetics Following a Single Dose of Intracranially Administered Temozolomide-based SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2024-01", "PrimaryCompletionDate": "2025-07", "Interventions": [ { "Name": "SI-053", "Type": "DRUG", "Description": "SI-053 will be used as an add-on to SoC for newly diagnosed GBM.In conjunction with surgical resection, SI-053 will be applied intracranially (i.c.) into the cavity that is formed after tumor resection. Post-operative chemoradiotherapy (including concomitant and adjuvant TMZ or following the CeTeG protocol) will be initiated at least 21 and no later than 35 days after SI-053 administration.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Double Bond Pharmaceutical AB", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03478462", "BriefTitle": "Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma", "OfficialTitle": "An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-04-30", "PrimaryCompletionDate": "2025-12-25", "Interventions": [ { "Name": "CLR 131", "Type": "DRUG", "Description": "IV dose of CLR 131, increased/decreased by dose level; single or fractionated dose", "OtherNames": [ "I-131-CLR1404" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cellectar Biosciences, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04671459", "BriefTitle": "TTFields and Radiosurgery of Recurrent Glioblastoma +/- 18F-Fluoro-Ethyl-Thyrosine", "OfficialTitle": "A Phase II Trial of Tumor Treating Fields (TTFields) Concomitant With Radiosurgery for the Treatment of Recurrent, Bevacizumab-naïve Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-12-26", "PrimaryCompletionDate": "2023-07-20", "Interventions": [ { "Name": "TTFields and SRS", "Type": "COMBINATION_PRODUCT", "Description": "SRS procedure will be delivered within 7 days after start of TTFields therapy . A 5-day SRS regimen is allowed. TTFields should be interrupted in time of SRS and start immediately after.", "OtherNames": [ "Optune, Stereotactic Radiosurgery" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Prof. Franciszek Lukaszczyk Memorial Oncology Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure GmbH" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00054496", "BriefTitle": "Erlotinib in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme", "OfficialTitle": "Phase II Study Trial Of Tarceva In Patients With Recurrent/Progressive Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2002-08", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "The Cleveland Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00104091", "BriefTitle": "Safety and Efficacy Study to Treat Recurrent Grade 4 Malignant Brain Tumors", "OfficialTitle": "A Multicenter Phase II Study of TP-38 in Those Patients With Glioblastoma Multiforme Who Have Recurred or Progressed After Previous Resection and Radiation Therapy and Are Scheduled for Gross Total Resection", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-12", "PrimaryCompletionDate": "2007-04", "Interventions": [ { "Name": "TP-38", "Type": "DRUG", "Description": "TP-38 is a recombinant chimeric protein composed of the epidermal growth factor (EGFR) binding ligand (TGF-α)and a genetically engineered form of the Pseudomonas exotoxin, PE-38.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Teva Branded Pharmaceutical Products R&D, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT06665724", "BriefTitle": "Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy (ALA SDT GLIOMA 401)", "OfficialTitle": "A Phase 1 Single Center Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-01-27", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "5-Aminolevulinic acid Hydrochloride (Gliolan®)", "Type": "DRUG", "Description": "Patients will receive 5-Aminolevulinic acid hydrochloride via oral administration (20 mg/kg) 6-8 hours before CV01 treatment.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CV01", "Type": "DEVICE", "Description": "Ultrasound will be delivered 6-8 hours after administration of 5-aminolevulinic acid hydrochloride. A total of 12 fields will be treated (10 treatment sites across the hemisphere with 2 additional treatments over areas of increased enhancement).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Universität Münster", "LeadSponsorClass": "OTHER", "Collaborators": [ "Alpheus Medical, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003474", "BriefTitle": "Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1996-03-14", "PrimaryCompletionDate": "2003-06-21", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00052208", "BriefTitle": "Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), ZD 1839 (Iressa), [NSC #715055] With Radiation Therapy in Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-03", "PrimaryCompletionDate": "2005-06", "Interventions": [ { "Name": "gefitinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Iressa", "ZD 1839" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02423525", "BriefTitle": "Safety Study of Afatinib for Brain Cancer", "OfficialTitle": "A Phase I Dose Escalation and Central Nervous System (CNS) Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients With Recurrent or Progressive Brain Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-12", "PrimaryCompletionDate": "2020-08", "Interventions": [ { "Name": "Afatinib", "Type": "DRUG", "Description": null, "OtherNames": [ "Gilotrif" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Santosh Kesari", "LeadSponsorClass": "OTHER", "Collaborators": [ "Boehringer Ingelheim" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01737346", "BriefTitle": "Procarbazine and Lomustine in Recurrent Glioblastoma", "OfficialTitle": "Phase 2 Clinical Trial of PC(Procarbazine-CCNU) Chemotherapy in Patients With Recurrent or Resistant Glioblastoma With Methylated MGMT", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2012-10", "PrimaryCompletionDate": "2013-09", "Interventions": [ { "Name": "lomustine and procarbazine", "Type": "DRUG", "Description": "1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles", "OtherNames": [ "CCNU", "Matulan" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Incheon St.Mary's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Center, Korea" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03630289", "BriefTitle": "Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM", "OfficialTitle": "Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2018-07-27", "PrimaryCompletionDate": "2023-05-15", "Interventions": [ { "Name": "Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)", "Type": "PROCEDURE", "Description": "Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.", "OtherNames": [ "surgical tissue flap", "tissue autograft" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04209790", "BriefTitle": "Neoadjuvant Chemoradiation for Resectable Glioblastoma", "OfficialTitle": "Phase II Study of Neoadjuvant Chemoradiation for Resectable Glioblastoma (NeoGlio)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2020-04-01", "PrimaryCompletionDate": "2022-09-14", "Interventions": [ { "Name": "Neoadjuvant chemoradiation", "Type": "RADIATION", "Description": "Intensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular Modulated Arc Therapy (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue.", "OtherNames": [ "Standard adjuvant therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Drug Therapy with Temozolomide (benzolamide) (Standard of Care)", "Type": "DRUG", "Description": "During Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg.", "OtherNames": [ "Neoadjuvant therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgery post Radiation and Temozolomide (benzolamide)", "Type": "PROCEDURE", "Description": "Surgical resection of GBM will be done after radiation and Temozolomide treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Geisinger Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05191784", "BriefTitle": "GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients", "OfficialTitle": "A Phase 2, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of GX-I7 in Combination With Bevacizumab in Recurrent Glioblastoma (GBM) Patients", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2022-01-26", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "GX-I7", "Type": "DRUG", "Description": "Administered by intramuscular (IM) injection", "OtherNames": [ "rhIL-7-hyFc", "Efineptakin alfa" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Administered by intravenous (IV) injection", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Genexine, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02820584", "BriefTitle": "A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-09", "PrimaryCompletionDate": "2017-06", "Interventions": [ { "Name": "GSC-loaded autologous dendritic cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00662506", "BriefTitle": "Cediranib, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase Ib/II Study of AZD2171 in Combination With Daily Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma Not Taking Enzyme-Inducing Anti-epileptic Drugs", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-04", "PrimaryCompletionDate": "2014-04", "Interventions": [ { "Name": "Cediranib Maleate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD2171", "AZD2171 Maleate", "Recentin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Diffusion Tensor Imaging", "Type": "PROCEDURE", "Description": "Undergo DTI", "OtherNames": [ "DTI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Diffusion Weighted Imaging", "Type": "PROCEDURE", "Description": "Undergo T1 weighted DCE-MRI", "OtherNames": [ "Diffusion Weighted MRI", "Diffusion-Weighted Magnetic Resonance Imaging", "Diffusion-Weighted MR Imaging", "Diffusion-Weighted MRI", "DWI", "DWI MRI", "DWI-MRI", "MR Diffusion-Weighted Imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Dynamic Contrast-Enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo DCE-MRI", "OtherNames": [ "DCE MRI", "DCE-MRI", "DYNAMIC CONTRAST ENHANCED MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Fludeoxyglucose F-18", "Type": "RADIATION", "Description": "Undergo 18 FDG PET", "OtherNames": [ "18FDG", "FDG", "fludeoxyglucose F 18", "Fludeoxyglucose F18", "Fluorine-18 2-Fluoro-2-deoxy-D-Glucose", "Fluorodeoxyglucose F18" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo IMRT", "OtherNames": [ "IMRT", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Perfusion Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo PWI", "OtherNames": [ "magnetic resonance perfusion imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo 18 F FDG-PET", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET SCAN", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003176", "BriefTitle": "Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma", "OfficialTitle": "A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1998-03-25", "PrimaryCompletionDate": "2001-12-03", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03048240", "BriefTitle": "INtraoperative photoDYnamic Therapy of GliOblastoma", "OfficialTitle": "A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma.", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-05-05", "PrimaryCompletionDate": "2021-04-28", "Interventions": [ { "Name": "\"perPDT\"", "Type": "DEVICE", "Description": "The protocol requires the realization of specific procedures in addition to the usual care.\n\nThe per-operative photodynamic therapy (\"perPDT\") added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "GLIOLAN", "Type": "DRUG", "Description": "patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital, Lille", "LeadSponsorClass": "OTHER", "Collaborators": [ "Institut National de la Santé Et de la Recherche Médicale, France" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05063682", "BriefTitle": "The Efficacy and Safety of Brain-targeting Immune Cells (EGFRvIII-CAR T Cells) in Treating Patients With Leptomeningeal Disease From Glioblastoma. Administering Patients EGFRvIII -CAR T Cells May Help to Recognize and Destroy Brain Tumor Cells in Patients", "OfficialTitle": "A Phase 1 Study to Evaluate EGFRvIII -Targeted Chimeric Antigen Receptor (CAR) T Cells for Adult Patients With Leptomeningeal Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2020-05-15", "PrimaryCompletionDate": "2023-10", "Interventions": [ { "Name": "EGFRvIII-specific hinge-optimized CD3 ζ-stimulatory/41BB-co-stimulatory Chimeric Antigen Receptor autologous T-lymphocytes", "Type": "BIOLOGICAL", "Description": "ICV administration", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Chembrain LTD", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University of Oulu", "Jyväskylä Central Hospital", "Apollo Hospital, New Delhi, India" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT02540135", "BriefTitle": "Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma", "OfficialTitle": "Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2015-03-01", "PrimaryCompletionDate": "2018-07-18", "Interventions": [ { "Name": "fluorescein", "Type": "OTHER", "Description": "fluorescein and conventional neuro-navigation", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "intraoperative MRI", "Type": "OTHER", "Description": "conventional neuro-navigation and iMRI", "OtherNames": [ "iMRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Colorado, Denver", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02649582", "BriefTitle": "Adjuvant Dendritic Cell-immunotherapy Plus Temozolomide in Glioblastoma Patients", "OfficialTitle": "Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-12", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Dendritic cell vaccine plus temozolomide chemotherapy", "Type": "BIOLOGICAL", "Description": "When eligible after total or subtotal resection (as assessed by neurosurgeon and post-operative brain MRI):\n\n1. Leukocyte apheresis (before chemoradiation): for DC vaccine production\n2. Chemoradiation (standard treatment: initiated as soon as the patient's hematological blood values are adequate after apheresis): 2 Gy once daily 5 days/week for 6 weeks with 75 mg/m² temozolomide daily from the first until the last day of radiotherapy (no longer than 49 days in total)\n3. Induction immunotherapy: intradermal vaccination with autologous WT1 mRNA-loaded DCs weekly (+/-1 day) for 3 weeks, starting ≥ 1 week after radiotherapy\n4. Chemo-immunotherapy: 150-200 mg/m²/d temozolomide days 1-5 every 28 days +/- 2 days (max. 12 months) starting ≥3 days after the third vaccine of the induction immunotherapy + DC vaccination on day 21±3 days of every 28-day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital, Antwerp", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003417", "BriefTitle": "Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Radiation Dose Escalation Study Applying Conformal Radiation Therapy in Supratentorial Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1998-09", "PrimaryCompletionDate": "2004-05", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01294735", "BriefTitle": "Study of the Safety and Efficacy of MK-4827 Given With Temozolomide in Participants With Advanced Cancer (MK-4827-014 AM1)", "OfficialTitle": "A Phase I Study of MK-4827 in Combination With Temozolomide in Patients With Advanced Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-02", "PrimaryCompletionDate": "2012-04", "Interventions": [ { "Name": "MK-4827", "Type": "DRUG", "Description": "MK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "MK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04541225", "BriefTitle": "Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors", "OfficialTitle": "Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2020-12-08", "PrimaryCompletionDate": "2022-08-31", "Interventions": [ { "Name": "NUV-422", "Type": "DRUG", "Description": "NUV-422 is an investigational drug for oral dosing.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Nuvation Bio Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05577091", "BriefTitle": "Tris-CAR-T Cell Therapy for Recurrent Glioblastoma", "OfficialTitle": "Phase 1 Study of Autologous Tris-CAR-T Cell Locoregional Immunotherapy for Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-09-30", "PrimaryCompletionDate": "2024-11-01", "Interventions": [ { "Name": "Inverse correlated dual-target, truncated IL7Ra modified CAR -expressing autologous T-lymphocytes.", "Type": "GENETIC", "Description": "Intratumoral or intraventricular administration via Ommaya reservoir.\n\nDose level 0: 1×10\\^7 autologous Tris-CAR-T cells, at least one dose, maximum 6 doses, 2 patients.\n\nDose level 1: 1×10\\^8/ 5×10\\^6 autologous Tris-CAR-T cells, at least one dose, maximum 6 doses, 2 patients. The dose of Dose level 1 will refer to the adverse effect of Dose level 0. When dose-related side effects occurred in 2 patients in the Dose level 0, the dose should be reduced to 5×10\\^6 cells.\n\nIn Dose levels 0 and 1, the second dose will be infused 28 days after the first dose, and the subsequent doses will be administered weekly.\n\nDose level 2: 5×10\\^7 autologous Tris-CAR-T cells, weekly administered, maximum 8 weeks, 4 patients. If the results of Dose levels 0 and 1 suggested that dose-related toxic side effects could have occurred in the 1×10\\^7cells dose, the researcher would re-determine the dosage of the multidose clinical exploration study.", "OtherNames": [ "Autologous Tris-CAR-T cell." ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Beijing Neurosurgical Institute", "Tasly Pharmaceutical Group Co., Ltd" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05095376", "BriefTitle": "Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma", "OfficialTitle": "A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2022-03-28", "PrimaryCompletionDate": "2026-08-08", "Interventions": [ { "Name": "Lomustine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea", "1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-", "Belustin", "Belustine", "CCNU", "Cecenu", "CeeNU", "Chloroethylcyclohexylnitrosourea", "Citostal", "Gleostine", "Lomeblastin", "Lomustinum", "Lucostin", "Lucostine", "N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea", "Prava", "RB-1509", "WR-139017" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Photon Beam Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "External beam radiation therapy using photons (procedure)", "Photon", "Photon EBRT", "Photon External Beam Radiotherapy", "PHOTON Therapy", "Radiation, Photon Beam" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NRG Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00717197", "BriefTitle": "Study of Capecitabine to Treat Recurrent High Grade Gliomas", "OfficialTitle": "Pilot Study to Determine Therapeutic Response of Oral Capecitabine (Xeloda) in Recurrent High Grade Gliomas (HGGs) by Establishing the Radiographic Response Rate Using Modified Macdonald Criteria", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2012-03", "Interventions": [ { "Name": "Capecitabine", "Type": "DRUG", "Description": "1,000-1,250 mg/m2 taken by mouth twice daily for 14 out of 21 consecutive days until progression or unacceptable toxicity.", "OtherNames": [ "Xeloda" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07244835", "BriefTitle": "A Study of DEG6498 in Participants With Solid Tumors", "OfficialTitle": "A First in Human Phase 1 Open-Label, Multicenter, Dose Escalation and Expansion Study of DEG6498 in Patients With Solid Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-11-13", "PrimaryCompletionDate": "2028-12", "Interventions": [ { "Name": "DEG6498", "Type": "DRUG", "Description": "DEG6498 is an orally bioavailable molecular glue drug that potently induces the degradation of human antigen R (HuR).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Degron Therapeutics Co.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07093814", "BriefTitle": "A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma", "OfficialTitle": "A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-09-02", "PrimaryCompletionDate": "2028-12-31", "Interventions": [ { "Name": "VRT106", "Type": "DRUG", "Description": "VRT106,intravenous", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Guangzhou Virotech Pharmaceutical Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02348255", "BriefTitle": "NovoTTF-100A With Bevacizumab and Carmustine in Treating Patients With Glioblastoma Multiforme in First Relapse", "OfficialTitle": "A Phase II, Multi-institutional Trial of NOVO-TTF-100A, BCNU and Bevacizumab for GBM in First Relapse", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2016-01", "PrimaryCompletionDate": "2017-01", "Interventions": [ { "Name": "Electric Field Therapy", "Type": "PROCEDURE", "Description": "Undergo NovoTTF-100A", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Avastin", "rhuMab-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Carmustine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "FDA 0345" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of California, Davis", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03587038", "BriefTitle": "OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma", "OfficialTitle": "Feasibility Pilot Study of OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-09-03", "PrimaryCompletionDate": "2020-12-23", "Interventions": [ { "Name": "OKN 007", "Type": "DRUG", "Description": "400 mg OKN-007/mL in a phosphate buffer", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "75 mg/m2", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Photon/Proton IMRT", "Type": "RADIATION", "Description": "standard of care treatment to be given 1 to 2 hours after OKN-007", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Oklahoma", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00641706", "BriefTitle": "Vorinostat and Bortezomib in Treating Patients With Progressive, Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Vorinostat (SAHA) in Combination With Bortezomib (PS-341) in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2010-07", "Interventions": [ { "Name": "vorinostat", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "L-001079038", "SAHA", "suberoylanilide hydroxamic acid", "Zolinza" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Patient undergoes surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "bortezomib", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "LDP 341", "MLN341", "VELCADE" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02798406", "BriefTitle": "Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects", "OfficialTitle": "A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-10-06", "PrimaryCompletionDate": "2021-03-17", "Interventions": [ { "Name": "DNX-2401", "Type": "BIOLOGICAL", "Description": "On Day 0, following brain tumor biopsy and confirmation of recurrent tumor, a single injection of DNX-2401 is administered directly into the brain tumor.", "OtherNames": [ "Oncolytic virus", "Genetically-modified adenovirus", "Delta-24", "Delta-24-RGD" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "pembrolizumab", "Type": "BIOLOGICAL", "Description": "Sequential intravenous administration every three weeks beginning 7-9 days after Day 0/DNX-2401", "OtherNames": [ "KEYTRUDA", "lambrolizumab", "MK-3475", "SCH 900475", "Checkpoint inhibitor", "monoclonal antibody", "anti-PD1/PD-L1" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1", "PD-L1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "DNAtrix, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-1", "PD-L1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT06193174", "BriefTitle": "Re-Administration of C134 in Patients With Recurrent GBM (C134-HSV-1)", "OfficialTitle": "A Phase IB (Repeat Dosing) Trial of Second Dose Oncolytic HSV Administered Intratumorally in Patients With Recurrent Malignant Glioma.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2024-06-21", "PrimaryCompletionDate": "2025-03-07", "Interventions": [ { "Name": "C134 Re-Administration", "Type": "DRUG", "Description": "Administration of a second dose of C134 to participants that have completed the study Trial of C134 in Patients With Recurrent GBM (C134-HSV-1).", "OtherNames": [ "C134-HSV-1 Re-Administration" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01107522", "BriefTitle": "Safety and Tolerability of Carboxyamidotriazole Orotate (CTO) in Solid Tumors or With Temodar® in Glioblastoma or Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas", "OfficialTitle": "A Phase I Study of Oral Carboxyamidotriazole Orotate (CTO) Titrated as a Single Agent in Patients With Advanced or Metastatic Solid Tumors and Titrated in Combination Therapy With Temodar® for Patients With Glioblastoma and Other Recurrent Malignant Gliomas or in Combination With Temodar® and Radiation Therapy for Patients With Newly Diagnosed Glioblastoma and Malignant Gliomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2010-05", "PrimaryCompletionDate": "2025-01", "Interventions": [ { "Name": "CTO", "Type": "DRUG", "Description": "Oral administration daily for 28 day cycles; starting dose of CTO = 50 mg/m2", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "CTO and Temodar®", "Type": "DRUG", "Description": "Oral administration of CTO daily for 28 day cycles, starting dose of CTO = 219 mg/m2.\n\nTemodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle.\n\nExpansion Cohort of 6 patients on fixed dose of 600mg CTO/day Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "CTO, Temodar®, Radiation therapy", "Type": "DRUG", "Description": "Oral administration of CTO daily for 28 day cycles; starting dose of CTO = 219 mg/m2 Temodar® administered orally at a dose of 75 mg/m2 daily during radiation therapy, then at 150mg/m2 for Days 1-5 of Cycle 1, and then up to 200 mg/m2 Days 1-5 of subsequent cycles Radiation: 3-dimensional conformal radiation therapy or, Radiation: intensity-modulated radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Tactical Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04674527", "BriefTitle": "Pilot Study of Elemene in Treating Patients With Refractory Glioblastoma", "OfficialTitle": "A Pilot Study of Elemene Injectable Emulsion in Treating Patients With Refractory Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-06-01", "PrimaryCompletionDate": "2023-06-01", "Interventions": [ { "Name": "Elemene", "Type": "DRUG", "Description": "Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.", "OtherNames": [ "elemene injectable emulsion" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.", "OtherNames": [ "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Hangzhou Normal University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02761070", "BriefTitle": "Bevacizumab Alone Versus Dose-dense Temozolomide Followed by Bevacizumab for Recurrent Glioblastoma, Phase III", "OfficialTitle": "A Multicenter Randomized Phase III Study for Recurrent Glioblastoma Comparing Bevacizumab Alone With Dose-dense Temozolomide Followed by Bevacizumab (JCOG1308C, RE-GEND-pIII)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2016-07-11", "PrimaryCompletionDate": "2025-11-10", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar", "Temodal" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Kyorin University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Japan Clinical Oncology Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06183983", "BriefTitle": "Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma", "OfficialTitle": "Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-01-03", "PrimaryCompletionDate": "2025-08", "Interventions": [ { "Name": "Extended or additional MRI-scan (with contrast) prior to radiotherapy", "Type": "DIAGNOSTIC_TEST", "Description": "The MRI-protocol before radiotherapy is extended with 20 minutes. Patients who would not have received an MRI-scan prior to radiotherapy, will get an extra MRI-scan when participating.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Erasmus Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05977322", "BriefTitle": "A Phase I Study of [177Lu]Lu-FF58 in Patients With Advanced Solid Tumors.", "OfficialTitle": "A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry and Preliminary Activity of [177Lu]Lu-FF58 in Patients With Selected Advanced Solid Tumors.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2023-10-06", "PrimaryCompletionDate": "2024-12-13", "Interventions": [ { "Name": "68Ga-FF58", "Type": "DRUG", "Description": "Kit for radiopharmaceutical preparation of 68Ga- FF58 solution for injection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "177Lu-FF58", "Type": "DRUG", "Description": "Solution for injection/infusion", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04388475", "BriefTitle": "Open-label Study Investigating of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase II Open-label Study Investigating the Efficacy, Safety and Pharmacokinetic Properties of OKN-007 Combined With Temozolomide in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-06-12", "PrimaryCompletionDate": "2024-05-08", "Interventions": [ { "Name": "OKN-007", "Type": "DRUG", "Description": "Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.", "OtherNames": [ "NXY-059, HPN-07" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Oblato, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003456", "BriefTitle": "Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1995-03-14", "PrimaryCompletionDate": "2004-12-07", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006656", "BriefTitle": "Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2000-06", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carmustine in ethanol", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Direct Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00612651", "BriefTitle": "PH I Addition of Farnesyl Transferase Inhibitor to Temozolomide for Pts w Gr 3 & 4 Malignant Gliomas", "OfficialTitle": "A Phase I Trial of the Addition of the Farnesyl Transferase Inhibitor, SCH 66336, to Temodar for Patients With Grade 3 and 4 Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-10", "PrimaryCompletionDate": "2009-01", "Interventions": [ { "Name": "Temodar and SCH 66336", "Type": "DRUG", "Description": "2 separate strata accrued independently: Stratum 1-pts receiving CYP3A4-inducing anticonvulsants. Stratum 2-pts on non CYP3A4-inducing anticonvulsants or pts not on any anti-convulsants. Each strata treated \\& escalated independent of each other. Temozolomide administered orally at dose of 150 mg/m2 daily for 5 days, at bedtime, for 1st cycle \\& escalated to 200 mg/m2 daily for 5 days, at bedtime during subsequent cycles if tolerated. Treatment cycles repeated every 4wks following doses of Temozolomide from previous cycle. SCH 66336 administered orally twice daily, approximately every 12hrs. Except as specifically noted, pts advised to take capsules wh morning \\& evening meals, with approximately 240ml of non-carbonated water. Initial doses will be 125mg BID for stratum 1 \\& 75mg BID for stratum2. Treatment cycles repeated every 4 wks following dose of Temozolomide from previous cycle.", "OtherNames": [ "Temodar-Temozolomide", "Farnesyl transferase inhibitor-SCH 66336" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06186401", "BriefTitle": "Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells", "OfficialTitle": "Phase 1 Study of Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13R alpha2 CAR (E-SYNC) T Cells in Adult Participants With EGFRvIII+ Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-04-30", "PrimaryCompletionDate": "2026-08-31", "Interventions": [ { "Name": "E-SYNC T Cells", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13R alpha2 CAR T Cells", "Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13R alpha2 CAR T Cells", "Autologous Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ra2 CAR T Cells" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Cyclophosphamide (non-investigational)", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Cytoxan", "Cytoxan Lyophilized", "Neosar" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Fludarabine (non-investigational)", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Fludara", "Oforta" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Leukapheresis", "Type": "PROCEDURE", "Description": "Undergo leukapheresis", "OtherNames": [ "Therapeutic Leukopheresis" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Surgical resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection of tumor tissue", "OtherNames": [ "Resection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Hideho Okada, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "California Institute for Regenerative Medicine (CIRM)", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT06512311", "BriefTitle": "Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening", "OfficialTitle": "Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial (ATTRACT)", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-07-10", "PrimaryCompletionDate": "2030-12-31", "Interventions": [ { "Name": "CBMed Drug Screening Plattform", "Type": "DIAGNOSTIC_TEST", "Description": "The main devices used within the drug screening process are purchased from PerkinElmer, Liconic Instruments, BioTek and Beckman Coulter Diagnostics.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical University of Vienna", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02510950", "BriefTitle": "Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2015-12-03", "PrimaryCompletionDate": "2017-02-14", "Interventions": [ { "Name": "Personalized peptide vaccine", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Poly-ICLC", "Type": "DRUG", "Description": null, "OtherNames": [ "Hiltonol" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00782756", "BriefTitle": "Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma", "OfficialTitle": "A Phase II Study of Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-10-28", "PrimaryCompletionDate": "2017-03-23", "Interventions": [ { "Name": "radiotherapy (RT) in combination with temozolomide and bevacizumab", "Type": "OTHER", "Description": "Bevacizumab10 mg/kg IV once every two weeks on days 1 and 15 of every cycle (Cycle defined as 28 days). Temozolomide 75mg/m2 daily beginning on day 1 through completion of radiotherapy. Hypofractionated dose painting IMRT will start on day 1 and will be delivered on a Monday, Wednesday, Friday schedule for a total of 6 fractions.\n\nPost RT therapy: Bevacizumab 10mg/kg IV every two weeks. Temozolomide 150-200mg/m2 daily for 5 consecutive days will be given on 28 day cycles.\n\nFollow up: CBC weekly, comprehensive panel and urinalysis monthly, blood pressure every other week. Neurological/physical examination monthly. Gd-enhanced MRI with perfusion every 2 cycles. Neurocognitive testing (approximately 4months post RT, 1 year after diagnosis and then annually in long term survivors). Blood sample for correlative studies monthly.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03557372", "BriefTitle": "Mathematical Model-Adapted Radiation In Glioblastoma", "OfficialTitle": "Mathematical Model-Adapted Radiation Fractionation Schedule for Patients With Recurrent Glioblastoma (MARS-Glio)", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2018-11-12", "PrimaryCompletionDate": "2022-11-09", "Interventions": [ { "Name": "Mathematical Model-Adapted Radiation Fractionation Schedule", "Type": "RADIATION", "Description": "* Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks\n* Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.\n* Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01721577", "BriefTitle": "Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas", "OfficialTitle": "Phase I/II Clinical Trial of the Safety, Tolerability, and Anti-tumor Efficacy of the IGF-1R Inhibitor, AXL1717 (Picropodophyllin), in the Treatment of Recurrent Malignant Astrocytomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-12", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "AXL1717", "Type": "DRUG", "Description": "IGF-1 receptor inhibitor", "OtherNames": [ "picropodophyllin" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rush University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Axelar AB" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00576641", "BriefTitle": "Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma", "OfficialTitle": "A Phase l Trial of Tumor Associated Antigen Pulsed Dendritic Cell Immunotherapy for Patients With Brain Stem Glioma and Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-05", "PrimaryCompletionDate": "2010-01", "Interventions": [ { "Name": "autologous dendritic cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cedars-Sinai Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04574856", "BriefTitle": "Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II Study of Multiparametric MR-Guided High Dose Adaptive Radiotherapy With Concurrent Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-11-04", "PrimaryCompletionDate": "2026-10", "Interventions": [ { "Name": "Dose-Intensified Radiotherapy", "Type": "RADIATION", "Description": "Adaptive, dose-intensified radiotherapy targeting an advanced imaging signature, with a target, nominal radiotherapy dose of 80 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide chemotherapy (75 mg/m2 daily for 6 weeks)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Adjuvant temozolomide", "Type": "DRUG", "Description": "Adjuvant temozolomide will be delivered at 150-200 mg/m2 days 1-5 every 28 days for 6 cycles, with additional cycles delivered at the discretion of the investigator.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Michigan Rogel Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00365222", "BriefTitle": "Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase II Study of Dose Intensive Temozolomide in Elderly Adults With Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2006-07", "PrimaryCompletionDate": "2007-06", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "temozolomide 75 mg/m2 /d", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "H. Lee Moffitt Cancer Center and Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02340156", "BriefTitle": "Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma", "OfficialTitle": "Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-12", "PrimaryCompletionDate": "2018-11", "Interventions": [ { "Name": "SGT-53", "Type": "GENETIC", "Description": "SGT-53, at 3.6 mg DNA per infusion, will be administered twice per week for 3 weeks (on Day 1, 4, 8, 11, 15 and 18 of each cycle) for 3 cycles. If SGT-53-related toxicity occurs, the dose of SGT-53 will be de-escalated to 2.4 or 1.2 mg DNA/infusion when appropriate.", "OtherNames": [], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "TMZ will be administered orally on days 9-13 of each cycle. In cycle 1, the dose of TMZ will be 150 mg/m². If the TMZ-related toxicities are tolerated in cycle 1, the dose of TMZ will be escalated to 200 mg/m² for cycle 2 and beyond. If TMZ-related toxicity occurs, the dose if TMZ will be de-escalated to 125 mg/m² (dose level -1), 100 mg/m² (dose level -2) or 75 mg/m² (dose level -3) when appropriate.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "SynerGene Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04044937", "BriefTitle": "Fluoroethyltyrosine for Evaluation of Intracranial Neoplasms", "OfficialTitle": "Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-10-29", "PrimaryCompletionDate": "2024-03-31", "Interventions": [ { "Name": "F-18 Fluoroethyltyrosine (FET)", "Type": "DRUG", "Description": "Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner", "OtherNames": [ "18F-FET", "18FET", "2''-[F18] Fluoro-ethyl-L-tyrosine", "[18F]-Fluoro-ethyl-L-tyrosine", "Fluorine-18 2''-Fluoroethyl-L-tyrosine", "Fluoroethyltyrosine F18", "O-(2[F18]fluoroethyl)-L-tyrosine" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography (PET)", "Type": "PROCEDURE", "Description": "All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography", "Positron Emission Tomography Scan", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Thomas Hope", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04547777", "BriefTitle": "Phase 1 Trial of D2C7-IT in Combination With 2141-V11 for Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1 Trial of D2C7-IT in Combination With an Fc-engineered Anti-CD40 Monoclonal Antibody (2141-V11) Administered Intratumorally Via Convection-Enhanced Delivery Followed by Perilymphatic Injections of 2141-V11 and Assessment of the Tumor Monorail for Adult Patients With Recurrent Malignant Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-07-09", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "D2C7-IT", "Type": "DRUG", "Description": "D2C7-IT intratumoral infusion", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "2141-V11", "Type": "DRUG", "Description": "2141-11 intratumoral infusion", "OtherNames": [ "anti-CD40" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rockefeller University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00005856", "BriefTitle": "Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-12", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "oxaliplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "1-OHP", "Dacotin", "Dacplat", "Eloxatin", "L-OHP" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03707457", "BriefTitle": "Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence of Glioblastoma", "OfficialTitle": "Phase I Protocol to Assess Safety of Biomarker-Driven Therapy Using Selective Immune Activators in Combination With Anti-PD-1 (Nivolumab) in Patients With First Recurrence of Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2019-03-22", "PrimaryCompletionDate": "2019-11-30", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "OtherNames": [ "anti-PD1" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Anti-GITR Monoclonal Antibody MK-4166", "Type": "DRUG", "Description": "Patients receive anti-GITR intravenously (IV) over 30 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "OtherNames": [ "anti-GITR" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "IDO1 inhibitor INCB024360", "Type": "DRUG", "Description": "Patients receive IDO1 inhibitor by mouth daily beginning on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Ipilimumab", "Type": "DRUG", "Description": "Patients receive ipilimumab intravenously (IV) over 90 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 21 days for up to 4 doses in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT01250470", "BriefTitle": "Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma", "OfficialTitle": "Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Survivin-Positive Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-09-05", "PrimaryCompletionDate": "2014-05-29", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Montanide ISA-51/Survivin Peptide Vaccine", "Type": "DRUG", "Description": "Given SC", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sargramostim", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [ "23-L-Leucinecolony-Stimulating Factor 2", "DRG-0012", "Leukine", "Prokine", "rhu GM-CFS", "Sagramostim", "Sargramostatin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Roswell Park Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01238237", "BriefTitle": "Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory GBM and AA", "OfficialTitle": "Phase I Trial of Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-12", "PrimaryCompletionDate": "2016-01", "Interventions": [ { "Name": "Superselective Intraarterial Cerebral Infusion of Cetuximab", "Type": "DRUG", "Description": "Intraarterial Mannitol 25% 3-10 ml to open the blood brain barrier followed by Intraarterial Cetuximab single dose (starting at 100mg/m2 and escalating up to 500mg/m2)", "OtherNames": [ "Erbitux" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01822275", "BriefTitle": "Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2019-09", "Interventions": [ { "Name": "Chemotherapy with Temodar.", "Type": "DRUG", "Description": "Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Maryland, Baltimore", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05318612", "BriefTitle": "Effectiveness of MR-guided LITT Therapy in Irresectable Glioblastoma (EMITT)", "OfficialTitle": "(Cost)Effectiveness of MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Prospective Multicenter Randomized Controlled Trial (EMITT)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2022-04-08", "PrimaryCompletionDate": "2025-10-31", "Interventions": [ { "Name": "Laser Interstitial Thermal Therapy (LITT)", "Type": "PROCEDURE", "Description": "LITT is a minimally invasive neurosurgical procedure in which a laser catheter is placed into the tumor and warms the tumor to such an extent that tumor tissue is destroyed. LITT is performed under MR-guidance.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Biopsy", "Type": "PROCEDURE", "Description": "A sample of tissue from the tumor is obtained to confirm the diagnosis.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Radboud University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dutch National Health Care Institute", "ZonMw: The Netherlands Organisation for Health Research and Development", "UMC Utrecht" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03107780", "BriefTitle": "Testing the Ability of AMG 232 (KRT 232) to Get Into the Tumor in Patients With Brain Cancer", "OfficialTitle": "Phase 0/I Study of AMG 232 (KRT 232) Concentrations in Brain Tissue in Patients With Recurrent Glioblastoma and of AMG 232 (KRT 232) in Combination With Radiation in Patients With Newly Diagnosed Glioblastoma and Unmethylated MGMT Promoters", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-07-09", "PrimaryCompletionDate": "2025-08-15", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo collection of blood and tissue samples", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Navtemadlin", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "(3R,5R,6S)-5-(3-Chlorophenyl)-6-(4-chlorophenyl)-3-methyl-1-((1S)-2-methyl-1-(((1-methylethyl)sulfonyl)methyl)propyl)-2-oxo-3-piperidineacetic Acid", "AMG 232", "AMG-232", "KRT 232", "KRT-232", "KRT232", "MDM2 Inhibitor KRT-232" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT03392545", "BriefTitle": "Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)", "OfficialTitle": "Combination of Immunization and Radiotherapy for Malignant Gliomas (InSituVac1)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2018-04-01", "PrimaryCompletionDate": "2020-04-01", "Interventions": [ { "Name": "Combined immune adjuvants and radiation", "Type": "COMBINATION_PRODUCT", "Description": "24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.", "OtherNames": [ "GM-CSF, poly I:C and radiation", "CAR-T", "TCR-T" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Duke University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00463008", "BriefTitle": "Pharmacologic Study of Methotrexate in Patients Undergoing Stereotactic Biopsy for Recurrent High-Grade Glioma", "OfficialTitle": "A Pharmacokinetic Study of Methotrexate Using an Intratumoral Microdialysis Catheter", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2004-05", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "methotrexate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01266031", "BriefTitle": "Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma", "OfficialTitle": "Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-07-12", "PrimaryCompletionDate": "2015-06-30", "Interventions": [ { "Name": "vorinostat", "Type": "DRUG", "Description": "Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.", "OtherNames": [ "Zolinza" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "DRUG", "Description": "Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "M.D. Anderson Cancer Center", "Genentech, Inc.", "Merck Sharp & Dohme LLC", "Brain Tumor Trials Collaborative", "Ohio State University", "Northwestern University Feinberg School of Medicine", "UF Health Cancer Center at Orlando Health", "Baylor Health Care System", "MUSC Hollings Cancer Center", "University of Utah Health System", "University of Washington", "Henry Ford Health System", "Columbia University", "Rush University Medical Center", "Endeavor Health", "The Cleveland Clinic", "University of North Carolina, Chapel Hill", "Washington University School of Medicine", "Texas Oncology-Austin" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05222802", "BriefTitle": "A Study to Evaluate ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)", "OfficialTitle": "A Phase 1 Study to Evaluate the CNS-Penetrant EGFR/ERBB1 Inhibitor ERAS-801 in Patients With Recurrent Glioblastoma (THUNDERBBOLT-1)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-02-25", "PrimaryCompletionDate": "2025-08-31", "Interventions": [ { "Name": "ERAS-801", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Katmai Pharmaceuticals Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Erasca, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT03739372", "BriefTitle": "Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma", "OfficialTitle": "A Pilot Trial Testing the Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan in Children and Young Adults With High Grade Glioma (Excluding Diffuse Intrinsic Pontine Glioma)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2018-11-28", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Specialized tumor board recommendation", "Type": "OTHER", "Description": "Based on the molecular profile, the specialized tumor board will determine an individualized treatment recommendation for each patient using up to four FDA approved drugs. In special circumstances, Investigational new drug (IND) study agents may be used.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pacific Pediatric Neuro-Oncology Consortium", "The V Foundation for Cancer Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02529072", "BriefTitle": "Nivolumab With DC Vaccines for Recurrent Brain Tumors", "OfficialTitle": "AVeRT: Anti-PD-1 Monoclonal Antibody (Nivolumab) in Combination With DC Vaccines for the Treatment of Recurrent Grade III and Grade IV Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-01", "PrimaryCompletionDate": "2017-09-15", "Interventions": [ { "Name": "nivolumab", "Type": "DRUG", "Description": "Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, programmed death-ligands 1 and 2, results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T cell responses to both foreign antigens as well as self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies. The clinical study product is a sterile solution for parenteral administration.", "OtherNames": [ "BMS-936558", "MDX1106" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "DC", "Type": "BIOLOGICAL", "Description": "DCs are potent immunostimulatory cells that continuously sample the antigenic environment of the host and specifically activate cluster of differentiation 4 positive (CD4+) and cluster of differentiation 8 positive (CD8+) T-cells and B-cells. They are at the crossroads of many of the elegant networks of the immune system, and DCs represent the most promising contemporary biologic entity for realizing the promise of immunotherapy. Potent immune responses and encouraging clinical results have been seen in Phase I and II human clinical trials in systemic cancers. Numerous animal studies and the investigator's institution's humans studies have demonstrated potent antitumor responses using DC-based immunotherapy against MGs.", "OtherNames": [ "DC vaccine", "pp65 DC vaccine", "Human CMV pp65-LAMP mRNA-pulsed autologous DCs", "CMV pp65 DCs" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Gary Archer Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb", "Duke Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT02859857", "BriefTitle": "Phase 1 Study of BXQ-350 in Adult Patients With Advanced Solid Tumors", "OfficialTitle": "Phase 1, Dose-Escalation, Open-label, Safety and Pharmacokinetic, First in Human Study of BXQ-350 Administered as a Single Agent by Intravenous Infusion in Adult Patients With Advanced Solid Tumors and Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-09-01", "PrimaryCompletionDate": "2019-06-17", "Interventions": [ { "Name": "BXQ-350", "Type": "DRUG", "Description": "BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes. When both the components are assembled together stable SapC-DOPS nanovesicles are formed(clinical formulation BXQ-350).", "OtherNames": [ "SapC-DOPS" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Bexion Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "CTI Clinical Trial and Consulting Services" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03619239", "BriefTitle": "Dose-escalation Study to Evaluate the Safety and Tolerability of GX-I7 in Patients With Glioblastoma", "OfficialTitle": "A Phase 1b, Dose-escalation Study to Evaluate the Safety, Tolerability, and the Lymphocyte Increasing Effects of GX-I7 Intramuscular Administration in Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-06-20", "PrimaryCompletionDate": "2020-09-25", "Interventions": [ { "Name": "GX-I7", "Type": "DRUG", "Description": "During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4\\~12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Genexine, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05043701", "BriefTitle": "Individualized Systems Medicine Functional Profiling for Recurrent Glioblastoma", "OfficialTitle": "Individualized Systems Medicine Strategy for Targeting Cancer Stem Cells in Patients With Recurrent Glioblastoma (ISM-GBM)", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-03-01", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Personalized drug combination", "Type": "DRUG", "Description": "A personalized drug combination will be prescribed to each patient based on the functional drug screen", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oslo University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Institute for Molecular Medicine" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02490930", "BriefTitle": "A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma", "OfficialTitle": "A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2015-07", "PrimaryCompletionDate": "2017-09", "Interventions": [ { "Name": "Fingolimod", "Type": "DRUG", "Description": "Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and temozolomide and will be discontinued immediately upon completion of the six weeks of therapy.", "OtherNames": [ "Gilenya" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02928575", "BriefTitle": "Combining Sunitinib, Temozolomide and Radiation to Treat Patients Diagnosed With Glioblastoma", "OfficialTitle": "A Phase II Trial of Concurrent Sunitinib, Temozolomide and Radiation Therapy Followed by Adjuvant Temozolomide for Newly Diagnosed Glioblastoma Patients With an Unmethylated MGMT Gene Promoter", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2012-08", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "Sunitinib", "Type": "DRUG", "Description": "Before concurrent treatment, patients will receive sunitinib orally at a dose of 12.5 mg once daily for one week prior to radiation. Patients will then receive a concomitant treatment of sunitinib at a dose of 12.5 mg once daily along with temozolomide (75 mg/m2 daily) along with radiotherapy (60 Gy in 30 fractions) over a period of 6 weeks.", "OtherNames": [ "Sutent (SU11248)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (75 mg/m2 daily) will be administered along with sunitinib (12.5 mg once daily) and radiotherapy (60 Gy in 30 fractions) over a period of 6 weeks. This concurrent treatment of sunitinib, temozolomide and radiotherapy is followed by a 1 month break after which the adjuvant temozolomide treatment is administered at a dose of 150/200mg/m2 daily, for 5 of 28 days over a period of 6 months.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Patients will receive a concomitant treatment of radiotherapy (60 Gy in 30 fractions), sunitinib (12.5 mg once daily) and temozolomide (75 mg/m2 daily) over a period of 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Bassam Abdulkarim", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer", "Canadian Cancer Society (CCS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01884740", "BriefTitle": "Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22", "OfficialTitle": "Phase I/II Trial Of Super-Selective Intraarterial Infusion Of Erbitux (Cetuximab) And Avastin (Bevacizumab)For Treatment Of Relapsed/Refractory Intracranial Glioma In Patients Under 22 Years Of Age", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-06", "PrimaryCompletionDate": "2018-10", "Interventions": [ { "Name": "SIACI of Erbitux and Bevacizumab", "Type": "DRUG", "Description": "Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).", "OtherNames": [ "Cetuximab", "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Weill Medical College of Cornell University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00619112", "BriefTitle": "Temozolomide in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "single arm study", "OtherNames": [ "temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02433392", "BriefTitle": "Study of Intraparenchymal Therapy as Adjunct Therapy in Patients With Recurrent, Resectable Glioblastoma Multiforme.", "OfficialTitle": "A Phase 1 Study of Intraparenchymal Therapy With Irinotecan Hydrochloride Drug-eluting Beads (CM-BC2) as an Adjunct Therapy to Best Standard of Care in Patients With Recurrent, Surgically Resectable Glioblastoma Multiforme.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2015-07", "Interventions": [ { "Name": "CM-BC2", "Type": "PROCEDURE", "Description": "CM-BC2 is a drug-eluting bead, a drug-device combination", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Boston Scientific Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University of Birmingham" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01582269", "BriefTitle": "A Study in Recurrent Glioblastoma (GB)", "OfficialTitle": "A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-04-26", "PrimaryCompletionDate": "2014-07-26", "Interventions": [ { "Name": "Galunisertib", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [ "LY2157299 monohydrate" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [ "Galunisertib-matched Placebo" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00004015", "BriefTitle": "Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery", "OfficialTitle": "Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-06", "PrimaryCompletionDate": "2003-07", "Interventions": [ { "Name": "sodium borocaptate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01310868", "BriefTitle": "Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma", "OfficialTitle": "An Evaluation of the Tolerability and Feasibility of Combining 5-Amino-Levulinic Acid (5-ALA) With Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2015-03", "Interventions": [ { "Name": "5-ALA", "Type": "DRUG", "Description": "5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers", "OtherNames": [ "Amino-levulinic Acid", "Gliolan" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Gliadel wafers", "Type": "DRUG", "Description": "The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.", "OtherNames": [ "Carmustine wafers", "polifeprosan 20 with carmustine implant" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist", "Type": "RADIATION", "Description": "60Gy in 30 fractions (2Gy per fraction given once daily, five days per week (Monday-Friday) over 6 weeks. Radiotherapy delivered to gross tumour volume with 2-3cm margin. Standard treatment following neurosurgery for glioblastoma", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist", "Type": "DRUG", "Description": "temozolomide given alongside the radiotherapy at 75mg/m2 daily from the first day of radiotherapy, until the last day of radiotherapy, but for no longer than 49 days. Standard treatment following neurosurgery for glioblastoma", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist", "Type": "DRUG", "Description": "Following a 4 week break after contomitant chemo/RT, temozolomide given 150-200mg/m2 TMZ 5/28 days for 6 cycles (dosage increase to 200mg/m2 on second and subsequent cycles dependent on haematological toxicity. Sites should follow local guidelines if different.). TMZ to be given on 5 consecutive days followed by 23 days with no TMZ, per cycle. Standard treatment following neurosurgery and concomitant chemo/RT for glioblastoma", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00004024", "BriefTitle": "Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma", "OfficialTitle": "Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1997-06", "PrimaryCompletionDate": "2004-01", "Interventions": [ { "Name": "aldesleukin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous tumor cell vaccine", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "muromonab-CD3", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic autologous lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Barbara Ann Karmanos Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03914742", "BriefTitle": "BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations", "OfficialTitle": "Phase I/II Study of BGB-290 With Temozolomide in Recurrent Gliomas With IDH1/2 Mutations", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-02-16", "PrimaryCompletionDate": "2023-10-31", "Interventions": [ { "Name": "PARP Inhibitor BGB-290", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BGB-290, PARP, Inhibitor BGB-290" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Temodar, Methazolastone" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "resection surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "BeiGene" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT01349660", "BriefTitle": "Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study of the Combination of BKM120 and Bevacizumab in Patients With Refractory Solid Tumors (Phase I) and Relapsed/Refractory Glioblastoma Multiforme (Phase II)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab 10 mg/kg IV every 2 weeks", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "BKM120", "Type": "DRUG", "Description": "BKM120 orally (PO) once daily", "OtherNames": [ "Buparlisib" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "SCRI Development Innovations, LLC", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04221503", "BriefTitle": "Niraparib/TTFields in GBM", "OfficialTitle": "A Phase II Study Evaluating the Efficacy and Safety of Niraparib and Tumor-Treating Fields in Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2019-12-30", "PrimaryCompletionDate": "2026-01", "Interventions": [ { "Name": "Niraparib", "Type": "DRUG", "Description": "Niraparib (\\[3S\\]-3-\\[4-{7-(aminocarbonyl)-2H-indazol-2-yl} phenyl\\] piperidine \\[tosylate monohydrate salt\\]) is an orally available, potent, highly selective poly (adenosine diphosphate \\[ADP\\]-ribose) polymerase (PARP) -1 and -2 inhibitor. The niraparib drug product is provided as 100-mg capsules filled with a dry blend of niraparib tosylate monohydrate, lactose monohydrate, and magnesium stearate in a hard gelatin capsule.", "OtherNames": [ "ZEJULA" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Optune", "Type": "DEVICE", "Description": "Optune, which is manufactured by Novocure, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields (\"TTFields\") within the human body. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells.", "OtherNames": [ "Tumor Treatment Fields (TTFields)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Planned surgical resection", "Type": "PROCEDURE", "Description": "Surgery of supratentorial glioblastoma (GBM).", "OtherNames": [ "Tumor Resection" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Tesaro, Inc.", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "NCTId": "NCT00047073", "BriefTitle": "Sirolimus in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "A Modified Phase I/II Trial Of Rapamycin In Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-07", "PrimaryCompletionDate": "2005-06", "Interventions": [ { "Name": "Rapamycin", "Type": "DRUG", "Description": "Phase 1: Initial dose 6mg on day 1 and then 2mg each day for 5-7 days before surgery. No dosing during surgery recovery. After recorvery 6mg loading dose on day 1 then 2mg each day. Cycle is every 4 weeks.\n\nDose escalation: Level 2: 15mg load/5mg/day, Level 3: 30mg load/10mg/day, Level 4: 45mg load/15mg/day.\n\nPhase 2: Will utilize dose established in phase I. Dosing schedule will remain the same.", "OtherNames": [ "Sirolimus" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Surgical resection.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Supportive Care", "Type": "PROCEDURE", "Description": "Corticosteroids should be used in smallest dose to control symptoms of cerebral edema and mass effect.\n\nAnti-seizure medications should be used as indicated. Febrile neutropenia may be managed according to local institution's infectious disease guidelines.\n\nIf neurosurgical management is required for reasons not due to tumor progression, these procedures must be documented.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT04200066", "BriefTitle": "A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma", "OfficialTitle": "A Phase 1 Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2022-06-01", "PrimaryCompletionDate": "2023-10-01", "Interventions": [ { "Name": "Temozolomide, Tamoxifen, Maprotiline", "Type": "DRUG", "Description": "Subjects will receive a combination of temozolomide and tamoxifen for two weeks. After that, they will receive a combination of temozolomide, tamoxifen and maprotiline for the remainder of the study. All drugs are administered orally. Subjects will undergo visits at the beginning of week 3, week 5 and week 7 that will involve multiple blood draws and ECGs to evaluate for pharmacokinetics and drug interactions. Response will be assessed every two months with an MRI and patients will continue on study as long as their tumors are under control and they are tolerating the regimen.", "OtherNames": [ "TMZ", "TMX", "TMT" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Rochester", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02345824", "BriefTitle": "Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma", "OfficialTitle": "Early-Phase Study to Assess Tumor Pharmacokinetics and Efficacy of the CDK4/6 Inhibitor Ribociclib (LEE011) in Patients With Recurrent Glioblastoma or Anaplastic Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2016-03", "PrimaryCompletionDate": "2019-09", "Interventions": [ { "Name": "Ribociclib", "Type": "DRUG", "Description": "CDK4/6 INHIBITOR", "OtherNames": [ "LEE011" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "University of Virginia", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT04430842", "BriefTitle": "Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S", "OfficialTitle": "A Phase 1, Open Label, Multi-Center, Single and Multiple Dose, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QBS10072S in Previously Treated Patients With Advanced or Metastatic Cancers With High LAT1 Signatures, and in Patients With Relapsed or Refractory Grade 4 Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2020-07-20", "PrimaryCompletionDate": "2022-09-21", "Interventions": [ { "Name": "QBS10072S", "Type": "DRUG", "Description": "QBS10072S targets cancers with high LAT1 expression.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Quadriga Biosciences, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Novotech (Australia) Pty Limited" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01499251", "BriefTitle": "Clinical Study on the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 1/1b, Open-label Study in Patients With Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination With Dose-dense Temozolomide", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2012-01", "PrimaryCompletionDate": "2016-01", "Interventions": [ { "Name": "Phase 1 Dose Escalation", "Type": "DRUG", "Description": "Macitentan 30, 60, 90 mg or higher in 30 mg dose increments, given orally, up to 150 mg, then 225 mg, 300 mg and 375 mg, unless otherwise decided by the Safety Monitoring Committee. Dose-dense temozolomide 150 mg/m2 body surface area alternating 1 week on 1 week off.", "OtherNames": [ "dose-dense temozolomide", "Macitentan" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Phase 1b", "Type": "DRUG", "Description": "Macitentan given orally and daily at doses/schedule determined from the dose escalation period. Dose-dense temozolomide 150mg/m2 body surface area alternating 1 week on 1 week off.", "OtherNames": [ "Macitentan", "dose-dense temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Ancillary Study", "Type": "DRUG", "Description": "Macitentan dosed initially for 8-14 days prior to craniotomy, then treatment interrupted from time of craniotomy until 7 days before start of dose dense temozolomide therapy. dose-dense temozolomide 150 mg/m2 body surface area alternating 1 week on 1 week off.", "OtherNames": [ "dose-dense temozolomide", "Macitentan" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Actelion", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01849146", "BriefTitle": "Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed or Recurrent Glioblastoma", "OfficialTitle": "Phase I Study of AZD1775 (Adavosertib) With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma and Evaluation of Intratumoral Drug Distribution in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-10-24", "PrimaryCompletionDate": "2021-07-29", "Interventions": [ { "Name": "Adavosertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD 1775", "AZD-1775", "AZD1775", "MK 1775", "MK-1775", "MK1775" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03746288", "BriefTitle": "To Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM)", "OfficialTitle": "A Multicenter, Randomized, Open-label, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2018-11-20", "PrimaryCompletionDate": "2021-07-01", "Interventions": [ { "Name": "CAN008", "Type": "DRUG", "Description": "CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day", "OtherNames": [ "Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "CANbridge Life Sciences Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02904525", "BriefTitle": "Glioblastoma: Validation and Comparison Between Primary Tumor and Its Murine Model", "OfficialTitle": "Towards Patient-specific Treatments in Glioblastoma: Comparison and Validation of High-resolution Imaging and Molecular Profiles of Human Glioblastoma and Respective Paired Orthotopic Xenografts in the Mouse", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2015-06", "PrimaryCompletionDate": "2021-01-27", "Interventions": [ { "Name": "7 Tesla MRI, no contrast agent", "Type": "DEVICE", "Description": "Patients with newly diagnosed glioblastoma undergo a 7Tesla MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Andreas Hottinger", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ecole Polytechnique Fédérale de Lausanne" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00629889", "BriefTitle": "Levetiracetam or Pregabalin in Treating Seizures in Patients Undergoing Chemotherapy and/or Radiation Therapy For Primary Brain Tumors", "OfficialTitle": "Levetiracetam and Pregabalin for Monotherapy in Patients With Brain Tumors and Seizures. A Phase II Randomized Study.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-02", "PrimaryCompletionDate": "2012-05", "Interventions": [ { "Name": "levetiracetam", "Type": "DRUG", "Description": "After inclusion, patients receive Levetiracetam 2x250mg per day. The medication may be increased, in intervals of 500mg of Levetiracetam of at least 24h up to maximally: Levetiracetam 2x1500mg.\n\nPatients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pregabalin", "Type": "DRUG", "Description": "After inclusion, patients receive Pregabalin 2x75mg per day. The medication may be increased, in intervals of 150mg of Pregabalin of at least 24h up to maximally: Pregabalin 2x300mg.\n\nPatients might be treated up to one year within the study. If well tolerated, treatment might continue after end of study.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dr Andrea Rossetti", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07274397", "BriefTitle": "Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma", "OfficialTitle": "Assessment of Early Post-operative Nuclear Imaging in Neurosurgery: a Safety and Feasibility Study in Patients Operated for Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2026-01-01", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Early post-operative brain PET-MRI with 18F-DOPA and Gadolinium", "Type": "DIAGNOSTIC_TEST", "Description": "This intervention consists of a combined brain PET-MRI imaging session performed within 48 hours after surgical resection of a suspected glioblastoma. The PET scan uses 18F-DOPA as the radiotracer, administered intravenously at a dose of 2 MBq/kg, with static brain acquisition starting immediately post-injection. The MRI includes standard sequences and gadolinium-based contrast-enhanced imaging. The goal is to assess the feasibility and safety of this early post-operative imaging procedure, and to validate imaging parameters for the detection of residual tumor. Radiation dosimetry and potential adverse events related to imaging agents will be monitored.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Beta Emitting Accurate Monitored Systems", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Assistance Publique - Hôpitaux de Paris, FRANCE" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00535379", "BriefTitle": "SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme", "OfficialTitle": "SUTENT (SUNITINIB, SU11248)in Patients With Recurrent or Progressive Glioblastoma Multiforme An Academic Prospective Single-arm Phase II Clinical Trial Including Ranslational Research Studies", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "Sunitinib", "Type": "DRUG", "Description": "Patients will receive SUTENT 37.5mg (3 x 12.5mg capsules) PO daily in the morning after breakfast. After 2 weeks without treatment-related adverse events grade ≥ 2 (ECOG common toxicity criteria: refer to Protocol Attachment A.4) a SUTENT dose escalation to 50mg (4 x 12.5mg capsules) PO daily has to be performed. Treatment will continue until patients develop progression of disease or until unacceptable adverse events occur.", "OtherNames": [ "SUTENT" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Medical University Innsbruck", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05759195", "BriefTitle": "Biomolecular Analysis for Predicting Response to Regorafenib", "OfficialTitle": "Tumor Biomolecular Analysis for Defining Predictive Factors for Response to Regorafenib in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2021-01-07", "PrimaryCompletionDate": "2024-09-30", "Interventions": [ { "Name": "Biomolecular tumor analysis", "Type": "DIAGNOSTIC_TEST", "Description": "NGS analysis, other molecular analyses on FFPE tumor tissue", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02799238", "BriefTitle": "Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma", "OfficialTitle": "An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-03", "PrimaryCompletionDate": "2019-11-14", "Interventions": [ { "Name": "ALECSAT", "Type": "BIOLOGICAL", "Description": "3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Radiotherapy 5 days/week for 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CytoVac A/S", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06499831", "BriefTitle": "18F-FET-PET/MRI vs Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas", "OfficialTitle": "18F-FET-PET/MRI Versus Standard MRI Alone for Stereotactic RadioTherapy Planning for High Grade Brain Gliomas: A Pilot Study", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2021-12-15", "PrimaryCompletionDate": "2025-01-31", "Interventions": [ { "Name": "0-(2-18F-Fluoroethyl)-L-Tyrosine", "Type": "DIAGNOSTIC_TEST", "Description": "0-(2-18F-Fluoroethyl)-L-Tyrosine positron emission tomography (FET) is an amino acid agent derived from tyrosine that is able to cross the blood brain barrier. It has been studied primarily in diagnosis and detection of tumor recurrence in glioblastomas with emerging evidence for its use in brain metastases. Compared to conventional MRI, FET-PET has been shown to delineate geographically distinct tumor volume in newly diagnosed GBM suggesting the complementarity of the two modalities.", "OtherNames": [ "FET" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sunnybrook Health Sciences Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04902586", "BriefTitle": "Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma", "OfficialTitle": "The Clinical Effect and Safety of Radiotherapy Concurrent of TTFields in the Treatment of Post-operation Patients With Glioblastoma.", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-06-19", "PrimaryCompletionDate": "2021-12-19", "Interventions": [ { "Name": "TTFields", "Type": "DEVICE", "Description": "The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Zhongnan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00080054", "BriefTitle": "A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas", "OfficialTitle": "Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": null, "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Motexafin Gadolinium Injection", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Pharmacyclics LLC.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03181477", "BriefTitle": "Study Evaluating the Efficacy of Radiotherapy With SIB-IMRT, Associated With Temozolomide in Glioblastomas", "OfficialTitle": "Multicenter Phase II Study Evaluating the Efficacy of Radiotherapy With Modulation Intensity and Integrated Boost (SIB-IMRT) at the Dose of 80Gy, Associated With Chemotherapy by Temozolomide in the Treatment of Adult Glioblastomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2017-04-07", "PrimaryCompletionDate": "2023-09-02", "Interventions": [ { "Name": "Radiotherapy", "Type": "DEVICE", "Description": "Radiotherapy of 80 GY + Chemotherapy (Temozolomide)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Georges Francois Leclerc", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003241", "BriefTitle": "Phenylacetate in Treating Children With Recurrent or Progressive Brain Tumors", "OfficialTitle": "Phase II Study of Phenylacetate in Pediatric Patients With Central Nervous System Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1998-05", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "phenylacetate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Texas Children's Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00879437", "BriefTitle": "Valproic Acid, Radiation, and Bevacizumab in Children With High Grade Gliomas or Diffuse Intrinsic Pontine Glioma", "OfficialTitle": "A Phase 2 Study of Valproic Acid and Radiation, Followed by Maintenance Valproic Acid and Bevacizumab in Children With Newly Diagnosed High-grade Gliomas or Brainstem Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-09-01", "PrimaryCompletionDate": "2015-08-30", "Interventions": [ { "Name": "Valproic acid", "Type": "DRUG", "Description": "Daily (pre-XRT, During XRT, Post-XRT and Maintenance Therapy) Started at 15 mg/kg/day divided into three doses a day as soon as patients have recovered from surgery but no later than the first day of XRT.\n\nDosage will be adjusted in increments of 5 mg/kg/day every 3-5 days to achieve and maintain trough concentrations between 85 and 115 mcg/ml", "OtherNames": [ "sodium valproate" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "All patients will receive bevacizumab (10 mg/kg iv) during the maintenance phase every two weeks for a maximum duration of therapy of 24 months.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Radiation therapy will start within 30 days of the definitive surgical procedure. Primary brain malignant gliomas will receive a total dose of between 54.0 and 59.4 Gy in 30-33 fractions over 6-7 weeks. Total dose will be 54.0 Gy for completely resected tumors and brainstem gliomas. The total dose will be 59.4 if the tumor is located in the brain but not the brainstem, and the tumor was incompletely resected. Primary spinal cord malignant gliomas will receive a total dose of between 50.4-54 Gy in 28-30 fractions over 5-6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Baylor College of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cook Children's Medical Center", "University of Oklahoma", "University of Texas, Southwestern Medical Center at Dallas", "The University of Texas Health Science Center at San Antonio", "M.D. Anderson Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05495295", "BriefTitle": "First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Advanced Solid Tumours", "OfficialTitle": "An Adaptive First-in-human Trial of PhOx430, a First-in-class Acetylglucosaminyltransferase V Inhibitor, in Patients With Advanced Solid Tumours (PhAST Trial)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-07-18", "PrimaryCompletionDate": "2024-11-04", "Interventions": [ { "Name": "PhOx430", "Type": "DRUG", "Description": "A standard 3 + 3 design will be followed. PhOx430 will be administered orally twice a day (bid), at a 12-hour interval, continuously in cycles of 21 days. At each dose level (DL), three patients will be included and the first patient will be observed for at least 21 days before enrolling the following two. Three additional patients will be enrolled at each DL if a DLT is observed in the first three patients.\n\nA maximum of 4 increasing Dose Levels are foreseen (10, 20, 40 and 70 mg/kg/day), and PhOx430 will be administered in two doses at a 12-hour interval.", "OtherNames": [ "Dose Escalation Phase - STEP 1 and STEP 2" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PhOx430", "Type": "DRUG", "Description": "The implementation of this cohort (Step 3) was decided by the Protocol Steering Committee (PSC) based on clinical and pharmacokinetic data obtained in Steps 1 and 2. Six patients will be enrolled, who will receive PhOx430 orally thrice a day (tid) at a -6-hour interval over 12 hours for 21 days, and then, starting from day 22, four times a day (qid) at a 4-hour interval over 12 hours, continuously in cycles of 21 days. PhOx430 will be taken in single doses of 1,200 mg to patients weighing ≥ 50 kg and of 600 mg to patients weighing \\< 50 kg, with no requirement for a full or empty stomach. The first patient will be observed after treatment start for at least 21 days before enrolling the following two. After the third patient is observed for 21 days after treatment start, 3 additional patients will be enrolled without waiting time between them. If the daily dose tested with the tid schedule is not deemed safe, the flat dose will be tested twice a day (bid) at a 12-hour interval.", "OtherNames": [ "Dose Escalation Phase - STEP 3 (Dosing-optimization Cohort)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Phost'In Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00281905", "BriefTitle": "Combination Chemotherapy With or Without Radiation Therapy in Treating Children With Brain Tumors", "OfficialTitle": "Management of Children Aged Less Than 3 Years With Brain Tumors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "1992-06", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "methotrexate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Cancer and Leukaemia Group", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06344130", "BriefTitle": "Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma", "OfficialTitle": "A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-10-01", "PrimaryCompletionDate": "2027-12-31", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiation therapy will be administered via a linear accelerator using 6 megavoltage (MV) photons or greater.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06991101", "BriefTitle": "Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma", "OfficialTitle": "Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-12-03", "PrimaryCompletionDate": "2030-12", "Interventions": [ { "Name": "Ruxolitinib", "Type": "DRUG", "Description": "\"During Radiation Therapy\" phase: 20 mg ruxolitinib will be self-administered orally (PO) twice every day (BID), starting on Day 1 for 6 weeks. Then there will be a 4-week break after radiotherapy is complete.\n\n\"Maintenance\" phase: Occurs thirty days (4 weeks) after receiving the last dose of radiotherapy. Ruxolitinib 20 mg will be self-administered PO BID, starting on Day 1 in consecutive 28-day cycles.\n\nEither phase:\n\nAside from the 30-day break, ruxolitinib will be continued daily until disease progression or treatment intolerance. Ruxolitinib should be administered at approximately the same time each day. The tablets should be swallowed whole with water and should not be opened, broken, or chewed. The dose may be reduced in the case of certain adverse events.", "OtherNames": [ "Jakavi" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "\"During Radiation Therapy\" phase: 75 mg/m\\^2 will be self-administered PO once every day, starting on Day 1, for 6 weeks. Then there will be a 4-week break after radiotherapy is complete.\n\n\"Maintenance\" phase: Occurs thirty days (4 weeks) after receiving the last dose of radiotherapy. Temozolomide 150-200 mg/m\\^2 will be self-administered PO BID, starting on Day 1 to Day 5 of each cycle for six cycles.\n\nEither phase:\n\nThe dose may be reduced in the case of certain adverse events.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiation will be administered every weekday (Monday to Friday) in 2 Gy fractions for 30 fractions during a 6-week period (60 Gy total).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Baptist Health South Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Incyte Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01817751", "BriefTitle": "Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "Phase 2 Study of Sorafenib, Valproic Acid, and Sildenafil in the Treatment of Recurrent High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-04-11", "PrimaryCompletionDate": "2020-08-27", "Interventions": [ { "Name": "sorafenib tosylate", "Type": "DRUG", "Description": "Given by mouth", "OtherNames": [ "pyridinecarboxamide, chloro-trifluoromethylphenyl pyridine-carboxylic acid methylamide-methylbenzenesulfonate tosylate, Nexavar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "valproic acid", "Type": "DRUG", "Description": "Given by mouth", "OtherNames": [ "2-Propylpentanoic or Propylvaleric Acid, Alti-Valproic, Depakene, Di-n-propylacetic Acid, Ergenyl, Novo-Valproic, VA, Valproate, Valproate Sodium" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sildenafil citrate", "Type": "DRUG", "Description": "Given by mouth", "OtherNames": [ "Viagra" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Virginia Commonwealth University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04270461", "BriefTitle": "NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors", "OfficialTitle": "A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2020-03-17", "PrimaryCompletionDate": "2020-10-17", "Interventions": [ { "Name": "NKG2D-based CAR T-cells", "Type": "BIOLOGICAL", "Description": "Autologous genetically modified anti-NKG2DLs CAR transduced T cells", "OtherNames": [ "KD-025 CAR T-cells" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jiujiang University Affiliated Hospital", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "KAEDI" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01124240", "BriefTitle": "Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene", "OfficialTitle": "Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2009-11", "PrimaryCompletionDate": "2012-11", "Interventions": [ { "Name": "Cilengitide", "Type": "DRUG", "Description": "Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.\n\nStarting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA \\< 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).\n\nAfter a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA \\< 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.", "OtherNames": [ "Temozolomide", "Procarbazine" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northern Sydney and Central Coast Area Health Service", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck KGaA, Darmstadt, Germany" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00031083", "BriefTitle": "Dose Escalation Study to Determine the Safety of IFN-Beta Gene Transfer in the Treatment of Grade III & Grade IV Gliomas", "OfficialTitle": "A Multi-center, Open Label, Two Part, Dose Escalation Study to Determine the Tolerability of Interferon-Beta Gene Transfer (BG00001) in the Treatment of Recurrent or Progressive Grade III and Grade IV Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-04-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Interferon-beta", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Biogen", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00209989", "BriefTitle": "Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-10", "PrimaryCompletionDate": "2011-06", "Interventions": [ { "Name": "Zarnestra", "Type": "DRUG", "Description": "ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "standard Radiation therapy", "Type": "PROCEDURE", "Description": "Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [ "Janssen-Cilag Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02864368", "BriefTitle": "Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens", "OfficialTitle": "Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2016-12-07", "PrimaryCompletionDate": "2020-06-15", "Interventions": [ { "Name": "5-day TMZ", "Type": "DRUG", "Description": "Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m\\^2/day on days 1-5 of each 28 day cycle", "OtherNames": [ "temozolomide", "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "21-day TMZ", "Type": "DRUG", "Description": "Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)", "OtherNames": [ "temozolomide", "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "PEP-CMV: Component A", "Type": "BIOLOGICAL", "Description": "500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tetanus-Diphtheria booster", "Type": "DRUG", "Description": "At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)", "OtherNames": [ "Td", "tetanus" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tetanus Pre-Conditioning", "Type": "DRUG", "Description": "All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ", "OtherNames": [ "Td", "Tetanus-Diphtheria", "tetanus" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "PEP-CMV: Component B", "Type": "BIOLOGICAL", "Description": "500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Eric Thompson, M.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "Annias Immunotherapeutics, Inc.", "National Institutes of Health (NIH)", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04699773", "BriefTitle": "LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)", "OfficialTitle": "Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy For Treatment Of Newly Diagnosed High-Grade Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2021-02-20", "PrimaryCompletionDate": "2027-02", "Interventions": [ { "Name": "LITT", "Type": "PROCEDURE", "Description": "This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.", "OtherNames": [ "Laser Interstitial thermal therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Hypofractionated Radiation Therapy", "Type": "RADIATION", "Description": "Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Maryland, Baltimore", "LeadSponsorClass": "OTHER", "Collaborators": [ "Keep Punching Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01925573", "BriefTitle": "Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)", "OfficialTitle": "Proposed Pilot Study of Combined Optune+ Bevacizumab, and Hypofractionated Stereotactic Irradiation for Bevacizumab-Naive Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2019-08", "Interventions": [ { "Name": "Optune(NOVOTTF-100A)", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Maryland, Baltimore", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04479241", "BriefTitle": "LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 2, Open-label, Single-arm Study Evaluating the Efficacy, Safety and Tolerability of Lerapolturev (PVSRIPO) and the Immune Checkpoint Inhibitor Pembrolizumab in the Treatment of Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-10-21", "PrimaryCompletionDate": "2024-06-05", "Interventions": [ { "Name": "lerapolturev", "Type": "BIOLOGICAL", "Description": "Lerapolturev (5x10\\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "pembrolizumab", "Type": "BIOLOGICAL", "Description": "Pembrolizumab (200 mg IV) given every 3 weeks.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Istari Oncology, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT03175224", "BriefTitle": "APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors", "OfficialTitle": "Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2017-09-27", "PrimaryCompletionDate": "2026-03-30", "Interventions": [ { "Name": "APL-101 Oral Capsules", "Type": "DRUG", "Description": "Subjects will receive APL-101 capsules BID for oral administration.", "OtherNames": [ "PLB-1001", "CBI-3103", "Bozitinib", "CBT-101", "Vebreltinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Apollomics Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05366179", "BriefTitle": "Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc", "OfficialTitle": "Phase I Study of Intraventricular Infusion of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) in Subjects With Recurrent or Refractory Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-09-02", "PrimaryCompletionDate": "2030-05-30", "Interventions": [ { "Name": "CAR.B7-H3T cells infusion", "Type": "DRUG", "Description": "The Chimeric Antigen Receptors (CAR).B7-H3T cells will be administered via intraventricular infusion up to 3 weekly infusions. A suspension of T cells infusion is given, over 5-10 minutes, via a Rickham catheter and will be followed by a normal-saline flush.\n\nDose escalation will be performed considering the dose limiting toxicities (DLTs) listed in the protocol. Six doses will be explored. The starting dose will be 2 × 10\\^6 transduced cells/infusion (Dose Level (DL) 1) and will enroll at least 3 subjects. If there are no dose DLTs within 4 weeks of the third cellular product administration in the first 3 subjects, then the next cohort will evaluate 5 × 10\\^6 transduced cells/infusion (DL2).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "UNC Lineberger Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03400917", "BriefTitle": "Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens for Treatment of Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase II Trial of Autologous Dendritic Cells Loaded With Autologous Tumor Associated Antigens (AV-GBM-1) as an Adjunctive Therapy Following Primary Surgery Plus Concurrent Chemoradiation in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2018-06-20", "PrimaryCompletionDate": "2021-12-01", "Interventions": [ { "Name": "AV-GBM-1", "Type": "BIOLOGICAL", "Description": "Investigational treatment with AV-GBM-1", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Aivita Biomedical, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01353625", "BriefTitle": "Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.", "OfficialTitle": "A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-04-25", "PrimaryCompletionDate": "2021-03-12", "Interventions": [ { "Name": "CC-115", "Type": "DRUG", "Description": "Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity).\n\nPart B: Optimal dose schedule is administered in 28-day cycles until disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00703859", "BriefTitle": "Combining Radiotherapy and Temozolomide With Dichloroacetate in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I Single Arm Trial Combining Radiotherapy and Temozolomide With Dichloroacetate (DCA) in Patients With Newly Diagnosed Glioblastoma Multiform Tumours", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2010-01", "Interventions": [ { "Name": "Dichloroacetate (DCA)", "Type": "DRUG", "Description": "DCA starting at an initial dose of 3mg/kg twice daily PO for consecutive days (days 1-5) on a 28 days cycle up to 6 cycles unless evidence of tumour progression. Each dose to be administered with food at the same time everyday 12 hours apart.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05990556", "BriefTitle": "Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients", "OfficialTitle": "Research on the Safety and Efficacy of Blocking Dural Blood Supply in Glioblastoma Patients", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-05-11", "PrimaryCompletionDate": "2025-09-01", "Interventions": [ { "Name": "interventional procedure to block bilateral meningeal blood supply", "Type": "PROCEDURE", "Description": "The embolic agent used in bilateral meningeal blood supply occlusion through interventional surgery is Onyx glue (\"liquid embolic system\"). After the location of bilateral middle meningeal artery was determined by femoral artery puncture angiography, SL-10 was sent to the opening of bilateral middle meningeal artery through guiding catheter, and Onxy glue was used to block the bilateral middle meningeal artery. The standard of embolization was that the middle meningeal artery was not seen and Onyx glue was not diffused to the petrous branch of the middle meningeal artery. In order to avoid dangerous anastomotic branches and complications, attention should be paid to superselecting the middle meningeal artery and slowly injecting Onyx glue during the operation. After embolization of the middle meningeal artery by interventional surgery, glioblastoma was removed immediately under the guidance of multimodal imaging.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "First Affiliated Hospital, Sun Yat-Sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05281731", "BriefTitle": "Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma", "OfficialTitle": "Sonobiopsy for Noninvasive and Sensitive Detection of Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-04-18", "PrimaryCompletionDate": "2028-11-30", "Interventions": [ { "Name": "Sonobiopsy", "Type": "DEVICE", "Description": "Ultrasound combined with microbubbles to facilitate sampling of biomarkers from brain tumors via blood-based liquid biopsy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Research blood", "Type": "PROCEDURE", "Description": "No more than 10 minutes prior to ultrasound sonication, 10 minutes after ultrasound sonication, 30 minutes after ultrasound sonication (optional at the discretion of the PI), and 60 minutes after ultrasound sonication (optional at the discretion of the PI)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cancer Personalized Profiling", "Type": "GENETIC", "Description": "Cancer Personalized Profiling by deep Sequencing will be used to compare the frequency of tumor-specific variants in the blood before and after sonobiopsy.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Definity®", "Type": "DEVICE", "Description": "Being used off-label in this trial", "OtherNames": [ "Definity® microbubbles" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07268053", "BriefTitle": "A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases", "OfficialTitle": "A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2026-01", "PrimaryCompletionDate": "2027-07", "Interventions": [ { "Name": "Risvutatug rezetecan", "Type": "DRUG", "Description": "Risvutatug rezetecan will be administered intravenously.", "OtherNames": [ "HS-20093", "GSK5764227" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02017717", "BriefTitle": "A Study of the Effectiveness and Safety of Nivolumab Compared to Bevacizumab and of Nivolumab With or Without Ipilimumab in Glioblastoma Patients", "OfficialTitle": "A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and Multiple Phase 1 Safety Cohorts of Nivolumab or Nivolumab in Combination With Ipilimumab Across Different Lines of Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2014-02-07", "PrimaryCompletionDate": "2019-06-17", "Interventions": [ { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "specified dose on specified days", "OtherNames": [ "BMS-936558" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "specified dose on specified days", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Ipilimumab", "Type": "BIOLOGICAL", "Description": "specified dose on specified days", "OtherNames": [ "Yervoy" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Bristol-Myers Squibb", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05091866", "BriefTitle": "Natural Progesterone for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "Pilot Study of Subcutaneously Administered Natural Progesterone for the Treatment of Recurrent GBM", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-04-11", "PrimaryCompletionDate": "2026-04-01", "Interventions": [ { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Progesterone", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [ "Corlutina", "Corluvite", "Corpus luteum hormone", "Cyclogest", "Gestiron", "Gestone", "Lipo-Lutin", "Luteohormone", "Lutocyclin", "Lutocylin M", "Lutogyl", "Lutromone", "Progestasert", "Progesterone", "Progestin", "Progestogel", "Progestol", "Progeston", "Prolidon", "Proluton", "Syngesterone", "Utrogestan" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01390571", "BriefTitle": "Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma", "OfficialTitle": "A Cancer Research UK Phase I Trial of Olaparib (AZD2281), an Oral PARP Inhibitor, in Combination With Extended Low-Dose Oral Temozolomide in Patients With Relapsed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-07", "PrimaryCompletionDate": "2017-06-20", "Interventions": [ { "Name": "olaparib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "gene expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "protein expression analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "diffusion-weighted magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "dynamic contrast-enhanced magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Cancer Research UK", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT03294486", "BriefTitle": "Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients", "OfficialTitle": "Safety and Efficacy of the ONCOlytic VIRus Armed for Local Chemotherapy, TG6002/5-FC, in Recurrent Glioblastoma Patients", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-10-12", "PrimaryCompletionDate": "2019-05", "Interventions": [ { "Name": "Combination of TG6002 and 5-flucytosine (5-FC, Ancotil®)", "Type": "DRUG", "Description": "Phase 1, TG6002 administered in a total volume of 250mL of saline solution (0.9 %) as three intravenous infusions at the following doses:\n\n* Dose 1 : 5.0 log10 pfu •Dose 2 : 6.0 log10 pfu •Dose 3 : 7.0 log10 pfu •Dose 4 : 7.5 log10 pfu\n* Dose 5 : 8.0 log10 pfu •Dose 6 : 8.5 log10 pfu Additional dose levels •Dose 2-1 : 5.5 log10 pfu •Dose 3-2 : 6.5 log10 pfu Phase 2a, treatment IV at the recommended Phase 2 dose 5-Flucytosine (5-FC) is provided in its commercial packaging with brand name ANCOTIL 500 mg, tablet (Ancotil®) marketed by MEDA Pharma: polypropylene tube containing 100 tablets.\n\n 5-FC administered orally as 500 mg tablets taken 4 times per day (qid). Daily starting dose is 200 mg/kg. The daily dose will be adjusted at Day 19 following the measurement of 5-FC plasma concentration at steady state (Day 7), which should be kept below 100 mg/L.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [ "Transgene" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05557292", "BriefTitle": "RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma", "OfficialTitle": "A Phase I/Ib, Open-Label, Dose-Escalation Study of RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-03", "PrimaryCompletionDate": "2030-04-30", "Interventions": [ { "Name": "RMC-5552", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "mTORC1/4EBP1" ], "modality": [ "Other" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Nicholas Butowski", "LeadSponsorClass": "OTHER", "Collaborators": [ "Revolution Medicines, Inc.", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT04840069", "BriefTitle": "Radiotherapy Planning Using Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II Randomized Clinical Trial of Radiotherapy Planning Using Conventional Imaging +/- Fluciclovine PET in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-06-07", "PrimaryCompletionDate": "2024-03-30", "Interventions": [ { "Name": "Fluciclovine PET guided Radiotherapy", "Type": "DRUG", "Description": "PET+MRI Based There is no GTV\\_5400. The GTV\\_6000 will be defined as the surgical cavity inclusive of any remaining tumor enhancement and the hypermetabolic volume. CTV\\_5400 will include the GTV\\_6000 plus a margin of 1.0 cm which may be reduced around natural barriers to tumor growth such as the skull, ventricles, falx, etc. CTV\\_5400 must also include the entirety of the GTV\\_6000. There is no CTV\\_6000. PTV\\_5400 is the CTV\\_5400 plus a geometric 3 mm expansion in all dimensions; PTV\\_6000 is GTV\\_6000 plus a geometric 3 mm expansion in all dimensions. PTV may extend beyond bony margins and the skin surface. The PTV\\_5400 must contain the PTV\\_6000. In the setting of multi-focal disease, the primary target volumes will be defined as above, but for satellite lesions, the GTV\\_6000 will be defined as any tumor enhancement and hypermetabolic volume. There will be no CTV\\_6000. PTV\\_6000 will be defined as GTV\\_6000 plus a geometric 3 mm expansion in all dimensions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Foundation", "Arizona Biomedical Research Commission (ABRC)", "Blue Earth Diagnostics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05139056", "BriefTitle": "Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients With Recurrent High-Grade Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-05-02", "PrimaryCompletionDate": "2026-08-07", "Interventions": [ { "Name": "Neural Stem Cells-expressing CRAd-S-pk7", "Type": "BIOLOGICAL", "Description": "Given intracerebrally", "OtherNames": [ "CRAd-S-pk7 loaded NSCs", "NSC-CRAd-S-pk7", "NSC-CRAd-S-pk7 Virotherapeutic", "NSCs loaded with CRAd-S-pk7", "SC-CRAd-Survivin-pk7" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Intracerebral administration of NSC-CRAd-S-pk7 via intracavitary catheter", "Removal of CSF samples via a catheter placed in the lateral cerebral ventricle" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03243851", "BriefTitle": "Study on Low Dose Temozolomide Plus Metformin or Placebo in Patient With Recurrent or Refractory Glioblastoma", "OfficialTitle": "Efficacy and Safety of Low Dose Temozolomide Plus Metformin as Combination Chemotherapy Compared With Low Dose Temozolomide Plus Placebo in Patient With Recurrent or Refractory Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-11-21", "PrimaryCompletionDate": "2020-12-31", "Interventions": [ { "Name": "Temozolomide+Metformin", "Type": "DRUG", "Description": "Low dose temozolomide+metformin for 24 weeks", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide+Placebo", "Type": "DRUG", "Description": "Low dose temozolomide+placebo for 24 weeks", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Yong-Kil Hong", "LeadSponsorClass": "OTHER", "Collaborators": [ "Saint Vincent's Hospital, Korea", "Incheon St.Mary's Hospital", "National Cancer Center, Korea", "Konkuk University Hospital", "Seoul National University Bundang Hospital", "Samsung Medical Center", "Seoul National University Hospital", "Asan Medical Center", "Ajou University School of Medicine", "Severance Hospital", "Chonnam National University Hospital", "Seoul St. Mary's Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03367715", "BriefTitle": "Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma", "OfficialTitle": "A Phase II, Open-label, Single Arm Trial of Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-02-07", "PrimaryCompletionDate": "2021-05-20", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "study treatment on Day 1 with one dose of nivolumab 3 mg/kg", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [] } }, { "Name": "Ipilimumab", "Type": "DRUG", "Description": "study treatment on Day 1 with one dose of ipilimumab 1mg/kg", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [] } }, { "Name": "Radiation Therapy (RT)", "Type": "RADIATION", "Description": "total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "MGMT", "PD-1" ], "classes": [] } }, { "NCTId": "NCT05370079", "BriefTitle": "Control Cohort CTRL COH", "OfficialTitle": "Control Cohort CTRL COH", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-08-08", "PrimaryCompletionDate": "2028-08-08", "Interventions": [ { "Name": "Collection of biological sample (blood and/or CSF)", "Type": "BIOLOGICAL", "Description": "Blood sample will be collected one time for each patient:\n\n2 \\*4ml of blood on dry tube 2 \\*4ml of blood on EDTA tube\n\nIf cerebrospinal fluid (CSF) has been drawn for diagnosis, remaining sample available will be stored in the control cohort (1 ml).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Hospices Civils de Lyon", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04479696", "BriefTitle": "Customized Neuro-Imaging Referenced Symptom Video for the Reduction of Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors", "OfficialTitle": "Novel Intervention to Reduce Patient and Caregiver Anxiety Around Radiation Treatment for Brain Tumors With a Customized Neuro-Imaging Referenced Symptom Video", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2019-06-05", "PrimaryCompletionDate": "2026-06-01", "Interventions": [ { "Name": "Educational Intervention", "Type": "OTHER", "Description": "Receive standard of care verbal and written education materials", "OtherNames": [ "Education for Intervention", "Intervention by Education", "Intervention through Education", "Intervention, Educational" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Survey Administration", "Type": "OTHER", "Description": "Complete optional survey", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Video", "Type": "OTHER", "Description": "Watch NIRS video", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05914935", "BriefTitle": "Safety and Tolerability Study of Recombinant L-IFN Adenovirus Injection in Patients With Recurrent Glioblastoma", "OfficialTitle": "Safety、Tolerability、Pharmacokinetics and Initial Efficacy of Recombinant L-IFN Adenovirus Injection in the Treatment of Recurrent Glioblastoma：an Open-label, Single-arm, Single-center, Multi-dose Investigator-initiated Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-06-27", "PrimaryCompletionDate": "2024-06-12", "Interventions": [ { "Name": "Recombinant L-IFN adenovirus injection", "Type": "DRUG", "Description": "The Ommaya reservoir was surgically implanted, and multiple intracapsular injections were given medicine. On the second day after Ommaya reservoir implantation, CT examination confirmed that the implantation was successful, and the experimental drug injection was started.", "OtherNames": [ "YSCH-01", "Oncolytic adenovirus" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Binhai Hospital of Fujian Medical University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Shanghai Yuansong Biotechnology Co., LTD" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02590497", "BriefTitle": "Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma Patients Before Surgery", "OfficialTitle": "The Correlation Between the Genetic and Neuroimaging Signatures in Newly Diagnosed Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2016-03-20", "PrimaryCompletionDate": "2017-10-26", "Interventions": [ { "Name": "Diffusion Weighted Imaging", "Type": "PROCEDURE", "Description": "Undergo diffusion weighted MRI", "OtherNames": [ "Diffusion Weighted MRI", "Diffusion-Weighted Magnetic Resonance Imaging", "Diffusion-Weighted MR Imaging", "Diffusion-Weighted MRI", "DWI", "DWI MRI", "DWI-MRI", "MR Diffusion-Weighted Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gadolinium", "Type": "DRUG", "Description": "Undergo gadolinium-enhanced MRI", "OtherNames": [ "Gd" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Tissue genetic analysis", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo gadolinium-enhanced MRI", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo 3D volumetric T1-weighted sequence", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo FLAIR sequence", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Perfusion Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo perfusion MRI", "OtherNames": [ "magnetic resonance perfusion imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ohio State University Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01972750", "BriefTitle": "Dovitinib (TKI258) in the Treatment of Patients With Relapsed Glioblastoma", "OfficialTitle": "The Multi-targeted Tyrosine Kinase Inhibitor Dovitinib (TKI258) in the Treatment of Patients With Relapsed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2013-10", "PrimaryCompletionDate": "2016-11", "Interventions": [ { "Name": "Dovitinib", "Type": "DRUG", "Description": "daily oral intake of capsule", "OtherNames": [ "TKI258" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "PD Dr. Martin Glas", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02311920", "BriefTitle": "Ipilimumab and/or Nivolumab in Combination With Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma", "OfficialTitle": "Phase I Study of Ipilimumab, Nivolumab, and the Combination in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-04-16", "PrimaryCompletionDate": "2017-12-31", "Interventions": [ { "Name": "Ipilimumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody", "BMS-734016", "Ipilimumab Biosimilar CS1002", "MDX-010", "MDX-CTLA4", "Yervoy" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "BMS-936558", "CMAB819", "MDX-1106", "NIVO", "Nivolumab Biosimilar CMAB819", "ONO-4538", "Opdivo" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06258018", "BriefTitle": "Niraparib and Temozolomide in Patients Glioblastoma", "OfficialTitle": "A Phase I-II Study of Niraparib Plus Temozolomide \"One Week on, One Week Off\" in Patients With Recurrent Isocitrate Dehydrogenase (IDH) Wild Type Glioblastoma and IDH Mutant Gliomas.", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-09", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Temodal", "Type": "DRUG", "Description": "given orally for 7 consecutive days, followed by 7 days OFF, in a cycle of 28 days", "OtherNames": [ "Temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Niraparib", "Type": "DRUG", "Description": "given orally in continous", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Armando Santoro, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Istituto Clinico Humanitas", "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT01071837", "BriefTitle": "APG101 in Glioblastoma", "OfficialTitle": "A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-12", "PrimaryCompletionDate": "2014-10", "Interventions": [ { "Name": "APG101", "Type": "DRUG", "Description": "400mg weekly as intravenous infusion", "OtherNames": [ "Recombinant fusion protein" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Blood drawing", "Type": "PROCEDURE", "Description": "Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Apogenix GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03576612", "BriefTitle": "GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas", "OfficialTitle": "Phase I Study of Neoadjuvant GMCI Plus Immune Checkpoint Inhibitor Combined With Standard of Care for Newly Diagnosed High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-02-27", "PrimaryCompletionDate": "2023-06-30", "Interventions": [ { "Name": "AdV-tk", "Type": "BIOLOGICAL", "Description": "Given IT", "OtherNames": [ "Aglatimagene Besadenovec" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Valacyclovir", "Type": "DRUG", "Description": "Given PO days 1-14; 1-3 days post surgery", "OtherNames": [ "124832-26-4", "L-Valine ester with 9-((2-hydroxyethoxy)methyl)guanine", "Zelitrex" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks", "OtherNames": [ "Irradiate", "irradiation", "radiotherapy", "RT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks", "OtherNames": [ "BMS-936558", "MDX-1106", "NIVO", "ONO-4538", "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Candel Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)", "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT06630260", "BriefTitle": "5G-RUBY: Avutometinib and Defactinib in Malignant Brain Tumours", "OfficialTitle": "A Phase 1/2 Trial of the Doublet Combination of Avutometinib and Defactinib and as a Triplet in Combination With Temozolomide in Patients With High Grade Malignant Brain Tumours Within the 5G Platform", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-11-15", "PrimaryCompletionDate": "2029-09-30", "Interventions": [ { "Name": "Avutometinib", "Type": "DRUG", "Description": "Supplied as 0.8mg capsules.", "OtherNames": [ "VS-6766" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Defactinib", "Type": "DRUG", "Description": "Supplied as 200mg tablets.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be supplied as 5, 20, 100, 140, 180 or 250 mg hard capsules.", "OtherNames": [ "Temodal" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Institute of Cancer Research, United Kingdom", "LeadSponsorClass": "OTHER", "Collaborators": [ "Minderoo Foundation", "Verastem, Inc.", "Royal Marsden NHS Foundation Trust", "Cambridge University Hospitals NHS Foundation Trust", "Cancer Research UK", "University of Cambridge" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00124657", "BriefTitle": "Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma", "OfficialTitle": "A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-03", "PrimaryCompletionDate": "2012-07", "Interventions": [ { "Name": "Erlotinib hydrochloride", "Type": "DRUG", "Description": "This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).", "OtherNames": [ "Tarceva", "OSI-774", "NSC#718781" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rady Children's Hospital, San Diego", "Duke University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01609790", "BriefTitle": "Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors", "OfficialTitle": "Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-06-04", "PrimaryCompletionDate": "2015-10-02", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 215", "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF Monoclonal Antibody SIBP04", "Anti-VEGF rhuMAb", "Avastin", "Bevacizumab awwb", "Bevacizumab Biosimilar ABP 215", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar CT-P16", "Bevacizumab Biosimilar FKB238", "Bevacizumab Biosimilar GB-222", "Bevacizumab Biosimilar HD204", "Bevacizumab Biosimilar HLX04", "Bevacizumab Biosimilar IBI305", "Bevacizumab Biosimilar LY01008", "Bevacizumab Biosimilar MIL60", "Bevacizumab Biosimilar Mvasi", "Bevacizumab Biosimilar MYL-1402O", "Bevacizumab Biosimilar QL 1101", "Bevacizumab Biosimilar RPH-001", "Bevacizumab Biosimilar SCT501", "Bevacizumab Biosimilar Zirabev", "Bevacizumab-awwb", "Bevacizumab-bvzr", "BP102", "BP102 Biosimilar", "HD204", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Mvasi", "MYL-1402O", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF", "SCT501", "SIBP 04", "SIBP-04", "SIBP04", "Zirabev" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Placebo Administration", "Type": "OTHER", "Description": "Given IV", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Trebananib", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "AMG 386", "AMG386", "Angiopoietin 1/2-Neutralizing Peptibody AMG 386" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00243490", "BriefTitle": "Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors", "OfficialTitle": "Prospective, Open-labeled, Clinical Trial in Compassionate Use to Evaluate the Efficacy and Safety of Photodynamic Therapy in the Treatment of Malignant Intracranial Tumors", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": null, "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Photodynamic therapy using Photosan and LumaCare™ Lamp Model LC-122M", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Taiwan University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00884416", "BriefTitle": "Sorafenib in Newly Diagnosed High Grade Glioma", "OfficialTitle": "Phase I Dose Finding Study of Sorafenib in Combination With Radiation Therapy and Temozolomide as a First Line Treatment of Patients With High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-03", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "Sorafenib dose escalation", "Type": "DRUG", "Description": "Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital, Geneva", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bayer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01380782", "BriefTitle": "BIBF 1120 for Recurrent High-Grade Gliomas", "OfficialTitle": "Phase II Trial of Triple Receptor Tyrosine Kinase Receptor Inhibitor BIBF 1120 in Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-05", "PrimaryCompletionDate": "2013-07", "Interventions": [ { "Name": "BIBF 1120", "Type": "DRUG", "Description": "200 mg BID oral for 28 day cycle", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Patrick Y. Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Boehringer Ingelheim", "Wake Forest University Health Sciences", "University of Virginia", "Massachusetts General Hospital", "The Cleveland Clinic" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02078648", "BriefTitle": "Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Subjects With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2017-09-01", "Interventions": [ { "Name": "SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)", "Type": "DRUG", "Description": "1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms.\n\nWithin 20 minutes following the administration of the SL-701 emulsion, poly-ICLC should be administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Bevacizumab infusions may occur over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "SL-701 + GM-CSF", "Type": "DRUG", "Description": "1.0 mL injection taken from 0.7 mL of SL-701 mixed at a 1:1 (v/v) ratio with 0.7 mL of Montanide. Preferred site of SC injection is in the right or left upper arms.\n\n150 μg GM-CSF should be administered as a SC injection immediately after SL-701 emulsion administration and within 1 cm from the center of the SL-701 emulsion injection site.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Imiquimod", "Type": "DRUG", "Description": "Within 5 minutes following the administration of the SL-701 emulsion, approximately 125 mg of imiquimod cream will be applied topically on the injection site. The imiquimod cream should be rubbed in until the cream is no longer visible.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stemline Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00923117", "BriefTitle": "Sunitinib to Treat Recurrent Brain Cancer", "OfficialTitle": "A Phase II Trial of Sunitinib in the Treatment of Recurrent Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2008-06", "PrimaryCompletionDate": "2012-06", "Interventions": [ { "Name": "Sutent (sunitinib)", "Type": "DRUG", "Description": "Oral dose 37.5 mg daily on a continuous 4 week cycle", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00003484", "BriefTitle": "Radiolabeled Monoclonal Antibody Therapy After Radiation Therapy in Treating Patients With Primary Brain Tumors", "OfficialTitle": "Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1997-09", "PrimaryCompletionDate": "2003-11", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 131 monoclonal antibody 81C6", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Darell D. Bigner, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00528684", "BriefTitle": "Safety and Efficacy Study of REOLYSIN® in the Treatment of Recurrent Malignant Gliomas", "OfficialTitle": "A Phase I/II Clinical Trial to Evaluate Dose Limiting Toxicity and Efficacy of Intralesional Administration of REOLYSIN® for the Treatment of Patients With Histologically Confirmed Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-07", "PrimaryCompletionDate": "2010-04", "Interventions": [ { "Name": "REOLYSIN®", "Type": "BIOLOGICAL", "Description": "REOLYSIN® is administered as a single intratumoral infusion over 72 hours. Dose levels in Phase 1 will be 1x10E8, 3x10E8, 1x10E9, 3x10E9, 1x10E10 TCID50. The dose level for Phase 2 will be the top dose reached in Phase 1.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Oncolytics Biotech", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02092038", "BriefTitle": "Preoperative Chemoradiation for Glioblastoma", "OfficialTitle": "Phase I Pilot Study of Preoperative Chemoradiation for Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-11", "PrimaryCompletionDate": "2015-07", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "partial brain irradiation", "Type": "RADIATION", "Description": "Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "stereotactic biopsy of brain tumor", "Type": "PROCEDURE", "Description": "will be assessed for tumor type and tumor markers", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "craniotomy and tumor resection", "Type": "PROCEDURE", "Description": "maximal safe resection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tampa General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05793021", "BriefTitle": "FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype", "OfficialTitle": "FKBP51s: a New Molecular Biomarker for Glioblastoma? Pre- and Post-operative Blood Levels Evaluation of FKBP51s Protein and Correlation With MRI Phenotype", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-07-08", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Blood sample", "Type": "DIAGNOSTIC_TEST", "Description": "Blood sample pre and post surgery to determine the level of FKBP51s protein", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01868906", "BriefTitle": "FMISO-PET in Brain Tumors and SCS Effect", "OfficialTitle": "Positron Emission Tomography With Fluoro-misonidazole (PET-FMISO) in High Grade Gliomas: Assessment of Tumor Hypoxia and Effect of Spinal Cord Stimulation", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2013-06", "PrimaryCompletionDate": "2017-09-17", "Interventions": [ { "Name": "18F-FMISO", "Type": "DRUG", "Description": "18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.", "OtherNames": [ "Fluoromisonidazole", "FMISO" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET without SCS", "Type": "PROCEDURE", "Description": "PET-scanning using 18F-fluoromisonidazole without SCS", "OtherNames": [ "Positron emission tomography scanning" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "SCS", "Type": "DEVICE", "Description": "Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.", "OtherNames": [ "Electrical Neurostimulation", "Spinal Cord Stimulation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET without/with SCS", "Type": "PROCEDURE", "Description": "Second PET-scanning using 18F-fluoromisonidazole: without/with SCS", "OtherNames": [ "Positron emission tomography scanning" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Standard radiation therapy", "OtherNames": [ "Radiation therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Standard treatment with concurrent and adjuvant Temozolomide.", "OtherNames": [ "Temodar", "Temodal", "Temcad" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bernardino Clavo, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Instituto Tecnologico Servicios Sanitarios, in MD Anderson Cancer Center, Madrid", "Instituto de Salud Carlos III", "Grupo de Investigación Clínica en Oncología Radioterapia", "Instituto Canario de Investigación del Cáncer", "RSbiomed", "Fundación DISA, Canary Islands, Spain" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06740955", "BriefTitle": "Hypofractionated Radiotherapy", "OfficialTitle": "A Randomized, Open, Controlled, Multi-center Clinical Trial of Hypofractionated Postoperative Radiotherapy for Adult Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-08-13", "PrimaryCompletionDate": "2027-12-30", "Interventions": [ { "Name": "hypofractionated postoperative radiotherapy", "Type": "RADIATION", "Description": "hypofractionated radiotherapy with a total dose of 52.5Gy, 3.5 Gy/ fraction, 15 fractions, 5 fractions per week,", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Conventionally fractionated postoperative radiotherapy", "Type": "RADIATION", "Description": "Conventionally fractionated radiotherapy with a total dose of 60 Gy, 2 Gy/ fraction, 30 fractions, 5 fractions per week,", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The First Hospital of Jilin University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00224978", "BriefTitle": "Chloroquine for Treatment of Glioblastoma Multiforme", "OfficialTitle": "Chloroquine as Adjuvant to the Treatment of Glioblastoma Multiforme, A Randomized Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2005-01", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Chloroquine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Institute of Neurology and Neurosurgery, Mexico", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00323115", "BriefTitle": "Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II Feasibility Study of Adjuvant Intra-Nodal Autologous Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-05", "PrimaryCompletionDate": "2008-04", "Interventions": [ { "Name": "Autologous Dendritic Cell", "Type": "BIOLOGICAL", "Description": "Vaccine given by cervical lymph node injection 3 times every other week", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Radiotherapy (RT) with concurrent temozolomide (TMZ) for 6 weeks before vaccine is SOC", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "PROCEDURE", "Description": "RT is standard of care (SOC) post surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "Vaccine given cervical lymphnode injection 3 times every other week", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02343549", "BriefTitle": "A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)", "OfficialTitle": "A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-01", "PrimaryCompletionDate": "2020-07-11", "Interventions": [ { "Name": "NovoTTF100A", "Type": "DEVICE", "Description": null, "OtherNames": [ "Optune(TM)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01122901", "BriefTitle": "Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Phase II and Pharmacodynamic Trial of RO4929097 for Patients With Recurrent/Progressive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2015-08", "Interventions": [ { "Name": "gamma-secretase/Notch signalling pathway inhibitor RO4929097", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "R4733", "RO4929097" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01985087", "BriefTitle": "A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70", "OfficialTitle": "A Phase I/ II Study of Hypofractionated Radiotherapy With Concurrent Temozolomide Followed by Adjuvant Temozolomide in Patients Over 70 Years Old With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-09", "PrimaryCompletionDate": "2025-05", "Interventions": [ { "Name": "Hypofractionated radiotherapy", "Type": "RADIATION", "Description": "Treatment of 3.4 Gy will be given daily 5 days per week over 2 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "During concomitant phase Temozolomide will be administered orally at 75 mg/m2 for 2 weeks concomitant with radiotherapy. During the adjuvant phase Temozolomide will be administered orally at 150 mg/m2 on days 1 through day 5 of each 28 day cycle for a maximum of 6 cycles.", "OtherNames": [ "Brand name Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Louisville", "LeadSponsorClass": "OTHER", "Collaborators": [ "James Graham Brown Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06533163", "BriefTitle": "Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial", "OfficialTitle": "Low-Intensity Oscillatory Magnetic Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM) - An Exposure-time Escalation Pilot Trial", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-02-17", "PrimaryCompletionDate": "2027-11", "Interventions": [ { "Name": "Oncomagnetic device", "Type": "DEVICE", "Description": "OncoMAGNETX has developed a portable wearable noninvasive magnetic device (Oncomagnetic device) for the treatment of GBM.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "BioTex, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05864534", "BriefTitle": "Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-01-31", "PrimaryCompletionDate": "2026-05", "Interventions": [ { "Name": "Balstilimab", "Type": "DRUG", "Description": "Balstilimab 450 mg IV over 30 minutes every 3 weeks", "OtherNames": [ "BAL" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Botensilimab", "Type": "DRUG", "Description": "Botensilimab1mg/kg mg IV over 30 minutes every 6 weeks", "OtherNames": [ "BOT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Liposomal Doxorubicin", "Type": "DRUG", "Description": "Liposomal Doxorubicin 30 mg IV over 30 minutes every 3 weeks", "OtherNames": [ "DOX" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sonocloud-9 (SC-9)", "Type": "DEVICE", "Description": "Device activation of 9 ultrasound emitters during IV injection of microbubbles every 3 weeks", "OtherNames": [ "SC-9" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Agenus Inc.", "CarThera" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07143812", "BriefTitle": "A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-10-23", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "MSC11FCD", "Type": "DRUG", "Description": "Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10\\^7, 3x10\\^7cells/dose Summary: Administer the investigational drug in the amount of 1x10\\^7, 3x10\\^7cells per dose into the tumor or the tumor removal site using a syringe during surgery.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "CHA University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04388033", "BriefTitle": "Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.", "OfficialTitle": "Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-12", "PrimaryCompletionDate": "2022-12", "Interventions": [ { "Name": "Dendritic Cell/Tumor Fusion Vaccine", "Type": "BIOLOGICAL", "Description": "Vaccine is derived from the participants dendritic cells and tumor cells.", "OtherNames": [ "DC/tumor cell fusion vaccine" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Interleukin-12", "Type": "DRUG", "Description": "Given subcutaneously at dose of 6ug twice for interval of one hour.", "OtherNames": [ "IL-12" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Hangzhou Medical Biotechnology Co., Ltd", "CyTIX.Inc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02648633", "BriefTitle": "Stereotactic Radiosurgery With Nivolumab and Valproate in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Pilot Study to Evaluate the Feasibility of the Combined Use of Stereotactic Radiosurgery With Nivolumab and Concurrent Valproate in Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2016-05-24", "PrimaryCompletionDate": "2017-02-21", "Interventions": [ { "Name": "Stereotactic Radiosurgery", "Type": "RADIATION", "Description": "Subjects will receive a single large dose of radiation to one or more lesions.", "OtherNames": [ "Gamma Knife Radiosurgery" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "3 mg/kg of nivolumab will be administered through IV infusion every two weeks following stereotactic radiosurgery.", "OtherNames": [ "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Valproate", "Type": "DRUG", "Description": "Subjects will begin regimen of valproate prior to radiosurgery and continue to receive therapy concurrently with nivolumab. Subjects will receive valproate daily with a target serum level of 75-100 μg/ml.", "OtherNames": [ "Valproic Acid", "Sodium Valproate", "Divalproex Sodium" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University of Virginia", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT02364206", "BriefTitle": "Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Study of LY2228820 With Radiotherapy Plus Concomitant TMZ in the Treatment of Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-06-08", "PrimaryCompletionDate": "2019-08", "Interventions": [ { "Name": "LY2228820", "Type": "DRUG", "Description": null, "OtherNames": [ "ralimetinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiotherapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Jean Perrin", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute, France", "ARC Foundation for Cancer Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01252459", "BriefTitle": "Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme - a Randomised Phase II Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2011-07", "PrimaryCompletionDate": "2013-07", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Experimental intervention (Arm A): High-precision re-irradiation (stereotactic fractionated radiation therapy (SFRT) and/or image guided radiation therapy, (IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on AA-PET: GTV = AA uptake on PET, clinical target volume (CTV) = GTV+3mm, PTV = CTV+2mm", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Control intervention (Arm B): High-precision re-irradiation (SFRT and/or IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on T1Gd-MRI: GTV = contrast enhancement on T1Gd-MRI, CTV = GTV+3mm, PTV = CTV+2mm", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital Freiburg", "LeadSponsorClass": "OTHER", "Collaborators": [ "Clinical Trials Center Freiburg", "University of Freiburg", "AG-NUK-RT" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02365662", "BriefTitle": "A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor", "OfficialTitle": "A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2015-01-09", "PrimaryCompletionDate": "2018-03-15", "Interventions": [ { "Name": "ABBV-221", "Type": "DRUG", "Description": "ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT02444546", "BriefTitle": "Wild-Type Reovirus in Combination With Sargramostim in Treating Younger Patients With High-Grade Relapsed or Refractory Brain Tumors", "OfficialTitle": "Phase 1 Study of Replication Competent Reovirus (Reolysin®) in Combination With GM-CSF in Pediatric Patients With Relapsed or Refractory Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-06-21", "PrimaryCompletionDate": "2018-07-13", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sargramostim", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [ "23-L-Leucinecolony-Stimulating Factor 2", "DRG-0012", "Leukine", "Prokine", "rhu GM-CFS", "Sagramostim", "Sargramostatin" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Wild-type Reovirus", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Reolysin" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02613988", "BriefTitle": "Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas", "OfficialTitle": "Early Response Assessment Using on 3T Advanced MR Imaging as Predictor of Long-term Treatment Response in Newly Diagnosed Glioblastomas", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-01-12", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "3 Tesla magnetic resonance imaging", "Type": "DEVICE", "Description": "High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Chemical exchange saturation transfer MRI", "Type": "DEVICE", "Description": "Amide proton transfer-weighted image", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Diffusion weighted MRI", "Type": "DEVICE", "Description": "diffusion-weighted image with b value 0, 1000, and 3000", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dynamic susceptibility contrast MRI", "Type": "DEVICE", "Description": "dual echo EPI sequence", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Asan Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04937413", "BriefTitle": "The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation", "OfficialTitle": "PEskE: A Phase 0/Surgical Window-of-opportunity Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Evolocumab in Patients With Recurrent High-grade Glioma or Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-10-08", "PrimaryCompletionDate": "2023-09-13", "Interventions": [ { "Name": "Evolocumab", "Type": "DRUG", "Description": "Evolocumab subcutaneous injection", "OtherNames": [ "Repatha" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02192359", "BriefTitle": "Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I Study of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan in Patients With Recurrent High-Grade Gliomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2016-03-07", "PrimaryCompletionDate": "2022-02-21", "Interventions": [ { "Name": "Carboxylesterase-expressing Allogeneic Neural Stem Cells", "Type": "BIOLOGICAL", "Description": "Given intracranially", "OtherNames": [ "CE-secreting Allogeneic NSCs", "hCE1m6-NSC" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Irinotecan Hydrochloride", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Campto", "Camptosar", "Camptothecin 11", "Camptothecin-11", "CPT 11", "CPT-11", "Irinomedac", "U-101440E", "Irinotecan Hydrochloride Trihydrate", "Irinotecan Monohydrochloride Trihydrate" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003788", "BriefTitle": "Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas", "OfficialTitle": "Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "1998-04", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "lomustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "porfimer sodium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "procarbazine hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "neoadjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Colorado Health Foundation", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00029783", "BriefTitle": "Efficacy of Distant Healing in Glioblastoma Treatment", "OfficialTitle": "Efficacy of Distant Healing in Glioblastoma Treatment", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-09", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Distant Healing", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Center for Complementary and Integrative Health (NCCIH)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01759810", "BriefTitle": "Proteome-based Personalized Immunotherapy of Glioblastoma", "OfficialTitle": "Proteome-based Personalized Immunotherapy of Malignant Brain Tumors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2012-12", "PrimaryCompletionDate": "2018-12", "Interventions": [ { "Name": "Dendritic vaccine, allogeneic hematopoietic stem cells, cytotoxic lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dendritic vaccine, autologous hematopoietic stem cells, cytotoxic lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NeuroVita Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "Blokhin's Russian Cancer Research Center", "Russian Foundation of Technological Development", "The Serbsky State Scientific Center for Social and Forensic Psychiatry", "National Institute of Regenerative Medicine", "SRC Bioclinicum" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03660761", "BriefTitle": "Apatinib in Recurrent or Refractory Intracranial Central Nervous System Malignant Tumors", "OfficialTitle": "Efficacy and Safety of Apatinib Combined With Dose-dense Temozolomide in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-03-03", "PrimaryCompletionDate": "2017-01-03", "Interventions": [ { "Name": "apatinib", "Type": "DRUG", "Description": "The patient was given a daily dose of apatinib 500mg (or based on weight). For adult, the dose of apatinib was prescribed with 425 mg or 500 mg per day and four weeks for a cycle. The dosage was modified to 250 mg if patients experienced ≧grade 2 hematologic adverse events, hand and foot syndrome, proteinuria, fecal ocular blood, or grade 3/4 hypertension, or other grade 3/4 adverse events. Apatinib was administrated until disease progression, unacceptable toxicity or death.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temodar", "Type": "DRUG", "Description": "dose-dense temozolomide (100 mg/m2 , 7 days on with 7 days off ) , 28d", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Rongjie Tao", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT06894979", "BriefTitle": "Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma", "OfficialTitle": "A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD1390 (NSC# 852149) When Combined With Focal Radiation in Pediatric Patients With High Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2026-02-01", "PrimaryCompletionDate": "2028-03-31", "Interventions": [ { "Name": "ATM Kinase Inhibitor AZD1390", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD-1390", "AZD1390" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood and cerebrospinal fluid collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Survey Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00003996", "BriefTitle": "Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Pre-irradiation Chemotherapy With BCNU, Cisplatin and Oral Etoposide Combined With Radiation Therapy in the Treatment of Grade 4 Astrocytoma (Glioblastoma)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-05", "PrimaryCompletionDate": "2001-08", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "chemotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "etoposide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00669669", "BriefTitle": "O6-Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cell in Treating Patients With Malignant Gliomas", "OfficialTitle": "Benzylguanine-Mediated Tumor Sensitization With Chemoprotected Autologous Stem Cells for Patients With Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-02-25", "PrimaryCompletionDate": "2018-07-06", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3D conformal IMRT", "OtherNames": [ "3-dimensional radiation therapy", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Autologous Hematopoietic Stem Cell Transplantation", "Type": "PROCEDURE", "Description": "Undergo autologous in vitro-treated peripheral blood stem cell transplant", "OtherNames": [ "Autologous Stem Cell Transplantation" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carmustine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BCNU", "Becenum", "Becenun", "BiCNU", "Bis(chloroethyl) Nitrosourea", "Bis-Chloronitrosourea", "Carmubris", "Carmustin", "Carmustinum", "FDA 0345", "Gliadel", "N,N'-Bis(2-chloroethyl)-N-nitrosourea", "Nitrourean", "Nitrumon", "SK 27702", "SRI 1720", "WR-139021" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Filgrastim", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [ "Filgrastim XM02", "G-CSF", "Neupogen", "r-metHuG-CSF", "Recombinant Methionyl Human Granulocyte Colony Stimulating Factor", "rG-CSF", "Tbo-filgrastim", "Tevagrastim" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "In Vitro-Treated Peripheral Blood Stem Cell Transplantation", "Type": "PROCEDURE", "Description": "Undergo autologous in vitro-treated peripheral blood stem cell transplant", "OtherNames": [ "in vitro-treated PBPC transplantation", "in vitro-treated peripheral blood progenitor cell transplantation" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3D conformal IMRT", "OtherNames": [ "IMRT", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "O6-Benzylguanine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "6-O-BENZYLGUANINE", "O(6)-Benzylguanine" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Plerixafor", "Type": "DRUG", "Description": "Given SC", "OtherNames": [ "AMD 3100", "JM-3100", "Mozobil", "SDZ SID 791" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Proton Beam Radiation Therapy", "Type": "RADIATION", "Description": "Undergo proton beam radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Fred Hutchinson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01800695", "BriefTitle": "Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme", "OfficialTitle": "A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 for Subjects With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-04-02", "PrimaryCompletionDate": "2017-06-19", "Interventions": [ { "Name": "ABT-414", "Type": "DRUG", "Description": "ABT-414 will be administered by intravenous infusion", "OtherNames": [ "Depatuxizumab Mafodotin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered per label and local prescribing regulations.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Whole Brain Radiation", "Type": "RADIATION", "Description": "Whole Brain radiation will be administered in 30 fractions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01591577", "BriefTitle": "Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Pulse Dosing of Lapatinib in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-12-07", "PrimaryCompletionDate": "2024-05-07", "Interventions": [ { "Name": "Lapatinib/Temozolomide/radiation", "Type": "OTHER", "Description": "Patients will be treated with a pulse dose of lapatinib every week and temozolomide 75 mg/m2 daily during radiation. Lapatinib will be administered beginning on the first day of radiation and temozolomide (+/-2 days). External beam fractionated regional radiation will be given on consecutive week days at 200 cGy daily doses to a total dose of 6000 cGy. Patients will have rest from temozolomide only for 2-4 weeks. Patients will continue with weekly pulse-dosing of lapatinib. After a 2-4 weeks rest(for temozolomide only) following completion of radiation therapy, temozolomide will be restarted as Cycle 1 at 150 mg/m2/day for 5 days out of every 28.Subsequent cycles can increase to 200 mg/m2/day as tolerated per investigator's judgment. Lapatinib pulse doses will be continued every week without interruption.Treatment will continue for 24 additional 28-day cycles of temozolomide if there is no evidence of progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline", "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT06448286", "BriefTitle": "PH Weighted Chemical Exchange Saturation Transfer MRI-Based Surgical Resection to Improve Survival in Patients With Glioblastoma", "OfficialTitle": "PH Weighted Chemical Exchange Saturation Transfer Based Surgical Resections of Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-12-01", "PrimaryCompletionDate": "2028-06-01", "Interventions": [ { "Name": "Chemical Exchange Saturation Transfer Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo CEST MRI", "OtherNames": [ "Chemical Exchange Saturation Transfer MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Contrast-enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo contrast-enhanced MRI", "OtherNames": [ "CONTRAST ENHANCED MRI", "Contrast-enhanced MRI", "MRI With Contrast" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo standard of care radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Surgical Procedure", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Operation", "Surgery", "Surgery Type", "Surgery, NOS", "Surgical", "Surgical Intervention", "Surgical Interventions", "Surgical Procedures", "Type of Surgery" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05772767", "BriefTitle": "Modulation of Ciliogenesis in Glioma Stem Cells", "OfficialTitle": "Control of Growth and Invasiveness of Glioblastoma by Modulation of Ciliogenesis in Glioma Stem Cells. A Novel Target Against Glioblastoma for Precision Medicine. RF-2019-12368786", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2021-02-15", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Biological sample collection", "Type": "OTHER", "Description": "Collection of tumor tissue and blood for stem cell culture and organoids generation.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dissecting ciliogenesis players", "Type": "OTHER", "Description": "Assessment of cilium-related transcriptome in glioblastoma stem cells. Modulation of cilium-related genes and administration of cilium-targeted drugs to glioblastoma stem cells in vitro and ex vivo in glioblastoma brain organoids.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Validating ciliogenesis players", "Type": "DIAGNOSTIC_TEST", "Description": "Cilium-related signature will be studied in tumor tissue to evaluate its prognostic role.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [ "Istituto Superiore di Sanità", "Fondazione C.N.R./Regione Toscana \"G. Monasterio\", Pisa, Italy" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01653834", "BriefTitle": "Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas", "OfficialTitle": "Feasibility of Lymphocyte Reinfusion in Newly Diagnosed High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2012-07", "PrimaryCompletionDate": "2014-01", "Interventions": [ { "Name": "Lymphocyte harvesting & reinfusion", "Type": "PROCEDURE", "Description": "Lymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05831995", "BriefTitle": "Safety and Effectiveness of ABM-168 in Adults with Advanced Solid Tumors.", "OfficialTitle": "A Phase I, First-In-Human, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of ABM-168 Administered Orally in Adult Patients with Advanced Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2023-03-30", "PrimaryCompletionDate": "2024-06-30", "Interventions": [ { "Name": "ABM-168", "Type": "DRUG", "Description": "Dosage: 0.5 mg; 2 mg; 6 mg; once daily by oral administration", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "ABM Therapeutics Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00335075", "BriefTitle": "Efficacy and Safety of Temodal vs Semustine in Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma (Study P03644)", "OfficialTitle": "A Multicenter, Open-Label, Randomized, Active-Controlled Parallel Groups Study Comparing the Efficacy and Safety of Temodal vs Semustine in the Treatment of Subjects With Recurrent Glioblastoma or Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2005-03-02", "PrimaryCompletionDate": "2006-02-23", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide orally for 5 consecutive days (Day 1 through Day 5) every 28 days, at a dose of 150 mg/m2/day for subjects previously treated with chemotherapy, or 200 mg/m2/day for subjects who have not received previous chemotherapy.", "OtherNames": [ "Temodal", "Temodar", "SCH 052365" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Semustine", "Type": "DRUG", "Description": "Semustine orally once every 28 days at a dose of 150 mg/m2/day.", "OtherNames": [ "Methyl-CCNU" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07145112", "BriefTitle": "Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma", "OfficialTitle": "A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-10-01", "PrimaryCompletionDate": "2027-07", "Interventions": [ { "Name": "Laser interstitial thermal therapy", "Type": "PROCEDURE", "Description": "MRI guided laser", "OtherNames": [ "LITT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Given orally (PO)", "OtherNames": [ "CCNU, Gleostine" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of California, Davis", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04900792", "BriefTitle": "A Safety Study of Pharmacologic Ascorbate and Ferumoxytol in Addition to Standard of Care Chemoradiation in Glioblastoma", "OfficialTitle": "A First-in-Human Clinical Trial of Pharmacologic Ascorbate and Ferumoxytol Combined With Concomitant Temozolomide and External Beam Radiation Therapy for Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-02-28", "PrimaryCompletionDate": "2025-05-13", "Interventions": [ { "Name": "Ferumoxytol injection", "Type": "DRUG", "Description": "Ferumoxytol is an iron replacement product FDA approved for treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). This trial uses the FDA approved dosage (512 mg iron) for iron-deficiency anemia in CKD.", "OtherNames": [ "Feraheme", "Ferumoxytol" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Pharmacological ascorbate", "Type": "DRUG", "Description": "Intravenous ascorbate", "OtherNames": [ "ASCOR", "vitamin C", "ascorbic acid" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "External beam radiation therapy", "Type": "RADIATION", "Description": "Photon based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM.", "OtherNames": [ "EBRT", "radiotherapy", "VMAT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is a cytotoxic alkylating agent administered orally that penetrates well into the central nervous system. It is a standard-of-care treatment for GBM.", "OtherNames": [ "Temodar", "temozolomide capsule" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bryan Allen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Holden Comprehensive Cancer Center", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02590263", "BriefTitle": "Study Evaluating ABT-414 in Japanese Subjects With Malignant Glioma", "OfficialTitle": "A Non-Randomized, Open-Label, Multi-Center Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Japanese Subjects With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-08-24", "PrimaryCompletionDate": "2020-08-27", "Interventions": [ { "Name": "Whole Brain Radiation", "Type": "RADIATION", "Description": "Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered per label.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "ABT-414", "Type": "DRUG", "Description": "ABT-414 will be administered by intravenous infusion", "OtherNames": [ "Depatuxizumab", "Mafodotin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04214392", "BriefTitle": "Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for the Treatment of MMP2+ Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Phase 1 Study to Evaluate Chimeric Antigen Receptor (CAR) T Cells With a Chlorotoxin Tumor-Targeting Domain for Patients With MMP2+ Recurrent or Progressive Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-02-26", "PrimaryCompletionDate": "2026-06-09", "Interventions": [ { "Name": "Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT delivery)", "Type": "BIOLOGICAL", "Description": "Given via ICT delivery", "OtherNames": [ "Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes (via ICT/ICV dual delivery)", "Type": "BIOLOGICAL", "Description": "Given via ICT/ICV dual delivery", "OtherNames": [ "Chlorotoxin-CD28-CD3z-CD19t-expressing CAR T-cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03234595", "BriefTitle": "A Phase I/IIa Study of Cerebraca Wafer Plus Adjuvant Temozolomide (TMZ) in Patients With Recurrent High Grade Glioma", "OfficialTitle": "Everfront Biotech Co., Ltd.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-11-01", "PrimaryCompletionDate": "2023-04-30", "Interventions": [ { "Name": "Cerebraca wafer", "Type": "DRUG", "Description": "Eligible patients will receive Cerebraca wafer implantation with adjuvant temozolomide (TMZ) for the safety and efficacy in this study. At Phase I, the MTD will be determined by DLT. At Phase IIa, up to 12 evaluable patients will be enrolled for the efficacy and safety of Cerebraca wafer implantation. At Phase IIa, the cavity surface after tumor removal will be maximally covered by Cerebraca wafer without exceeding the MTD defined at Phase I. Patients in Phase I receive treatment as designed for Phase IIa, the data will be incorporated into Phase IIa to reduce the patient number. The overall patient number in this study is therefore between 2 to 36 evaluable patients.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Everfront Biotech Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "DOIT, Ministry of Economic Affairs, Taiwan" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06097975", "BriefTitle": "A Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma", "OfficialTitle": "A Phase I Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-03-15", "PrimaryCompletionDate": "2025-06-01", "Interventions": [ { "Name": "Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV", "Type": "DRUG", "Description": "Participants will receive neo-adjuvant administration of intravenous immunotherapy on day 1 + day 22: ipilimumab + nivolumab IV.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Neurosurgery and intracavitary injection nivolumab and ipililumab", "Type": "PROCEDURE", "Description": "The neo-adjuvant therapy will be followed by a maximal safe surgery resection of the glioblastoma. Immunotherapy (nivolumab + ipililumab) will be injected into the brain tissue, followed by insertion of an Ommaya reservoir", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary", "Type": "DRUG", "Description": "Postoperatively, administration of immunotherapy will be continued, on day 15 postoperatively and every 2 weeks thereafter patients will receive nivolumab IV as well as ipililumab + nivolumab intracavitary.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Universitair Ziekenhuis Brussel", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "NCTId": "NCT03916757", "BriefTitle": "V-Boost Immunotherapy in Glioblastoma Multiforme Brain Cancer", "OfficialTitle": "Open-label Phase II Trial of the Safety and Efficacy of V-Boost in Patients With Refractory Glioblastoma Multiforme (GBM)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2019-04-16", "PrimaryCompletionDate": "2020-04-15", "Interventions": [ { "Name": "V-Boost", "Type": "BIOLOGICAL", "Description": "Open label setting", "OtherNames": [ "V-Boost Immunitor" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Immunitor LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003464", "BriefTitle": "Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme", "OfficialTitle": "Phase II Treatment of Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme With Temodal", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1997-09", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01165671", "BriefTitle": "Carbon Ion Radiotherapy for Primary Glioblastoma", "OfficialTitle": "Randomized Phase II Study Evaluating a Carbon Ion Boost Applied After Combined Radiochemotherapy With Temozolomide Versus a Proton Boost After Radiochemotherapy With Temozolomide in Patients With Primary Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2010-07", "PrimaryCompletionDate": "2015-01", "Interventions": [ { "Name": "Carbon Ion Radiotherapy", "Type": "RADIATION", "Description": "Carbon ion Radiotherapy up to 18 Gy E in 3 Gy E fractions to the macroscopic tumor", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Proton Radiotherapy", "Type": "RADIATION", "Description": "Proton Radiotherapy up to 10 Gy E in 2 Gy E fractions to the macroscopic tumor", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital Heidelberg", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003463", "BriefTitle": "Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas", "OfficialTitle": "Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-07", "PrimaryCompletionDate": "2002-07", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "polifeprosan 20 with carmustine implant", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06556563", "BriefTitle": "EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-02-03", "PrimaryCompletionDate": "2029-04", "Interventions": [ { "Name": "Optune® device", "Type": "DEVICE", "Description": "Optune® device delivering TTFields therapy at 200 kHz.", "OtherNames": [ "TTFields" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide per approved labeling.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Placebo (saline solution) dose throughout this study is 200 mg IV Q3W for a maximum of 35 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NovoCure GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003067", "BriefTitle": "Biological Therapy in Treating Patients With Primary or Advanced Glioma", "OfficialTitle": "Intracavitary Interleukin-2 (IL-2) and Lymphokine-Activated Killer (LAK) Cell Therapy for Malignant Gliomas", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE2" ], "StartDate": "1997-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "aldesleukin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "lymphokine-activated killer cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Weill Medical College of Cornell University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04006119", "BriefTitle": "Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab in Subjects With Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Phase II Study of Ad-RTS-hIL-12 + Veledimex in Combination With Cemiplimab-rwlc (Libtayo®) in Subjects With Recurrent or Progressive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2019-08-01", "PrimaryCompletionDate": "2021-08-05", "Interventions": [ { "Name": "Ad-RTS-hIL-12", "Type": "BIOLOGICAL", "Description": "* intratumoral injection of Ad-RTS-hIL-12\n* 2.0 x 10\\^11 viral particles (vp) per injection", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Veledimex", "Type": "DRUG", "Description": "20mg/day 15 oral daily doses of veledimex", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cemiplimab-Rwlc", "Type": "DRUG", "Description": "Infusion every 3 weeks (350mg)", "OtherNames": [ "Libtayo", "REGN2810" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alaunos Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00016991", "BriefTitle": "ZD 1839 in Treating Patients With Glioblastoma Multiforme in First Relapse", "OfficialTitle": "A Phase II Study of ZD 1839 (NSC 715055) for Patients With First Relapse Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-06", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "gefitinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05743595", "BriefTitle": "Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OfficialTitle": "A Pilot Study to Assess the Safety and Immunogenicity of a Neoantigen-based Personalized DNA Vaccine With Retifanlimab PD-1 Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-10-27", "PrimaryCompletionDate": "2027-04-30", "Interventions": [ { "Name": "Personalized Neoantigen DNA vaccine", "Type": "BIOLOGICAL", "Description": "The sites of immunization may be rotated for each of the immunizations.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Retifanlimab", "Type": "BIOLOGICAL", "Description": "Retifanlimab will be supplied by Incyte.", "OtherNames": [ "INCMGA00012", "MGA012" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "TDS-IM v 2.0 electroporation device", "Type": "DEVICE", "Description": "Each DNA vaccination will be 1 mL vaccine administered intramuscularly using an integrated electroporation administration system", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Incyte Corporation", "PapiVax Biotech, Inc.", "The Foundation for Barnes-Jewish Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT05768919", "BriefTitle": "Study of Liposomal Curcumin in Combination With RT and TMZ in Patients With Newly Diagnosed High-Grade Gliomas", "OfficialTitle": "Phase I/II Study of the Tolerability, Safety, and Efficacy of Liposomal Curcumin in Combination With Radiation and Temozolomide in Patients With Newly Diagnosed High-Grade Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-03-03", "PrimaryCompletionDate": "2026-02", "Interventions": [ { "Name": "Treatment Period 1", "Type": "DRUG", "Description": "Agent: LipoCurc Premedication/Precautions: Dexamethasone 4mg IV, Diphenhydramine 25 mg IV - Dose: per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Weeks 1,2, 3,4,5,6 Cycle length: 6 weeks\n\nAgent: TMZ Premedications/Precautions No food 2 hr before and after dosing Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener PRN. Dose: 75 mg/m2 Route: Oral Schedule: Daily during term of RT Cycle Length: 6 weeks\n\nAgent: Radiotherapy Premedications/Precautions: n/a Dose: 2 Gy Route: External beam therapy Schedule: Monday-Friday Cycle Length 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Treatment Period 2", "Type": "DRUG", "Description": "Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Weeks 7,8,9,10 Cycle length: 4 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Treatment Period 3", "Type": "DRUG", "Description": "Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: Adjuvant Cycles 11-34 Weeks 1, 2, 3, 4 of each cycle Cycle Length: 4 weeks\n\nAgent: TMZ Premedication/Precautions: No food 2 hr before and after dosing. Antiemetic (eg, ondansetron, prochlorperazine) 30 minutes before dosing Stool softener prn Dose: 150-200 mg/m2 (Cycles 1-6) Route: Oral Schedule: Daily Cycle Length: 4 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Treatment Period 4a", "Type": "DRUG", "Description": "Agent: LipoCurc Premedication/Precautions: Dexamethasone 4 mg IV Diphenhydramine 25 mg IV Dose: Per treatment assignment Route: IV over approximately 3 hours Schedule: Weekly: 35+ Weeks 1, 2, 3, 4 of each cycle Cycle Length: 4 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "SignPath Pharma, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Avance Clinical Pty Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00005951", "BriefTitle": "Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma", "OfficialTitle": "Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2000-08", "PrimaryCompletionDate": "2006-04", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00743353", "BriefTitle": "Exploratory, Phase 0 Study of Positron Emission Tomography (PET) Imaging Agent, F-18 RGD-K5", "OfficialTitle": "An Exploratory, Multi-Center, Open Label, Non-Randomized Study of F-18 RGD-K5", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2008-08", "PrimaryCompletionDate": "2009-01", "Interventions": [ { "Name": "F-18 RGD-K5", "Type": "DRUG", "Description": "Study Drug F-18 RGD-K5 administered for diagnostic PET Imaging to be observed for a maximum of 4 hours, followed by 24 hour follow up", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Siemens Molecular Imaging", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06860594", "BriefTitle": "Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma", "OfficialTitle": "A Phase I Trial Combining Triapine With Radiation Therapy for Recurrent Glioblastoma or Astrocytoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-30", "PrimaryCompletionDate": "2027-06-30", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood and CSF sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized axial tomography (procedure)", "Computerized Tomography", "Computerized Tomography (CT) scan", "CT", "CT Scan", "Diagnostic CAT Scan", "Diagnostic CAT Scan Service Type", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo IMRT", "OtherNames": [ "IMRT", "Intensity modulated radiation therapy (procedure)", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy", "Radiation, Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Triapine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "3-aminopyridine-2-carboxaldehyde thiosemicarbazone", "3-AP", "3-Apct", "OCX-0191", "OCX-191", "OCX191", "PAN-811" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00612430", "BriefTitle": "Ph II Bevacizumab + Etoposide for Pts w Recurrent MG", "OfficialTitle": "Phase II Trial of Bevacizumab Plus Etoposide for Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-03", "PrimaryCompletionDate": "2008-09", "Interventions": [ { "Name": "Bevacizumab and Etoposide", "Type": "DRUG", "Description": "32 pts w recurrent WHO grade III MG \\& 27 pts w recurrent WHO grade IV MG will be enrolled in this study. Estimated rate of accrual is 10 pts per month. The estimated date of study completion is 6-9 months from study initiation. Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If pt tolerates 1st bevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day. The Duke investigators will review all la data \\& order treatment. Treatment will continue until either evidence of progressive disease, unacceptable toxicity, non-compliance w study follow-up, or withdrawal of consent.", "OtherNames": [ "Bevacizumab - Avastin", "Etoposide-Etopophos-Toposar-VePesid-VP-16" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00074243", "BriefTitle": "CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas", "OfficialTitle": "A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2003-12", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "CC-8490", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04762069", "BriefTitle": "A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Multicenter, Open-Label Study With a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients With Recurrent Glioblastoma Multiforme After Failure of Standard First Line Therapy", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-05-18", "PrimaryCompletionDate": "2026-02-01", "Interventions": [ { "Name": "Berubicin", "Type": "DRUG", "Description": "Berubicin HCl is a novel synthetic anthracycline with a chemical structure similar to doxorubicin HCl, a cytotoxic anthracycline topoisomerase II inhibitor isolated from cultures of Streptomyces peucetius var. caesius.", "OtherNames": [ "Berubicin Hydrochloride" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Lomustine is an anti-cancer (\"antineoplastic\" or \"cytotoxic\") chemotherapy drug. This medication is classified as an \"alkylating agent.", "OtherNames": [ "Lomustine Capsules", "CCNU", "CeeNU", "Gleostine" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CNS Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Worldwide Clinical Trials" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01111097", "BriefTitle": "Study of the Safety and Efficacy of Dichloroacetate (DCA) in Glioblastoma and Other Recurrent Brain Tumors", "OfficialTitle": "Phase 1, Open-Label, Single-Arm, Clinical and Metabolomics Study of Dichloroacetate (DCA) in Adults With Recurrent Malignant Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2014-03", "Interventions": [ { "Name": "Dichloroacetate", "Type": "DRUG", "Description": "Subjects after passing the inclusion criteria are given a dose of dichloroacetate 4mg/kg bid for thirty days. While in the clinical research center they participate in a breath test where they exhale through a straw into a glass tube. This will measure CO2. They are monitored every two weeks for side effects and return to the clinical research center for evaluation in thirty days. They undergo another breath test and if all health parameters are within normal limits they are given a month's supply of dichloroacetate. The cycles continue unless a serious adverse event occurs or the PI judges the side effects preclude another 30 days of medication", "OtherNames": [ "DCA" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03322813", "BriefTitle": "ExAblate Blood Brain Barrier Disruption (BBBD) for Planned Surgery in Suspected Infiltrating Glioma", "OfficialTitle": "A Study to Evaluate the Safety and Feasibility of Exablate Model 4000 Type-2 to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) in Patients With Suspected Infiltrating Glioma in the Setting of Planned Surgical Interventions", "OverallStatus": "SUSPENDED", "Phase": [ "NA" ], "StartDate": "2023-10", "PrimaryCompletionDate": "2024-09", "Interventions": [ { "Name": "ExAblate 4000 - Type 2", "Type": "DEVICE", "Description": "Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection", "OtherNames": [ "ExAblate BBBD" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00005813", "BriefTitle": "Bispecific Antibody Plus White Blood Cells in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme", "OfficialTitle": "A Phase I Trial of Intratumoral Bispecific Antibody and Activated Monocytes in Patients With Recurrent or Refractory Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1997-03", "PrimaryCompletionDate": "2003-01", "Interventions": [ { "Name": "bispecific antibody MDX447", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "lymphokine-activated killer cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00014573", "BriefTitle": "Chemotherapy and Vaccine Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Recurrent or Refractory Brain Cancer", "OfficialTitle": "Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1998-08", "PrimaryCompletionDate": "2004-10", "Interventions": [ { "Name": "aldesleukin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "autologous tumor cell vaccine", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "therapeutic autologous lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "paclitaxel", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Barbara Ann Karmanos Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02055196", "BriefTitle": "Genetically Modified Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I Study of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan in Patients With Recurrent High-Grade Gliomas", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": null, "PrimaryCompletionDate": "2014-05", "Interventions": [ { "Name": "carboxylesterase-expressing allogeneic neural stem cells", "Type": "BIOLOGICAL", "Description": "Given via intracerebral catheter", "OtherNames": [ "hCE1m6-NSC" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Campto", "Camptosar", "CPT-11", "irinotecan", "U-101440E" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03296696", "BriefTitle": "Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma", "OfficialTitle": "Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 as Monotherapy and in Combination With AMG 404 in Subjects With Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-04-18", "PrimaryCompletionDate": "2021-07-01", "Interventions": [ { "Name": "AMG 596", "Type": "DRUG", "Description": "Drug", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "AMG 404", "Type": "DRUG", "Description": "Drug", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Amgen", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT02844062", "BriefTitle": "Pilot Study of Autologous Anti-EGFRvIII CAR T Cells in Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Safety and Efficacy Study of Autologous Chimeric Antigen Receptor Engineered T Cells Redirected to EGFRvIII in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2016-07", "PrimaryCompletionDate": "2018-07", "Interventions": [ { "Name": "anti-EGFRvIII CAR T cells", "Type": "BIOLOGICAL", "Description": "CAR T cells are infused intravenously to patients in a three-day split-dose regimen（day0,10%; day1, 30%; day2, 60%）with a total targeted dose.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": "250 mg/m\\^2 d1-3", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Fludarabine", "Type": "DRUG", "Description": "25mg/m\\^2 d1-3", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Beijing Sanbo Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Marino Biotechnology Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT03973879", "BriefTitle": "Combination of PVSRIPO and Atezolizumab for Adults With Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1b/2 Trial of PVSRIPO in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-02", "PrimaryCompletionDate": "2024-01", "Interventions": [ { "Name": "PVSRIPO", "Type": "BIOLOGICAL", "Description": "Oncolytic polio/rhinovirus recombinant", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Atezolizumab", "Type": "DRUG", "Description": "Antibody", "OtherNames": [ "Tecentriq" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Istari Oncology, Inc.", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT00306618", "BriefTitle": "Safety and Efficacy Study of Panzem NCD to Treat Glioblastoma", "OfficialTitle": "A Single-Center, Open-Label, Phase II, Safety, Pharmacokinetic and Efficacy of Panzem Nanocrystal Colloidal Dispersion Administered Orally to Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-01", "PrimaryCompletionDate": "2007-11", "Interventions": [ { "Name": "Panzem Nanocrystal Colloidal Dispersion", "Type": "DRUG", "Description": "Panzem NCD suspension, 100 mg/mL, four times daily continuous dosing", "OtherNames": [ "2-methoxyestradiol", "2ME2" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "CASI Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01702610", "BriefTitle": "Phase II Trial of Neo-adjuvant Temozolomide Prior to Combined Temozolomide and Concurrent Accelerated Hypofractionated External Beam Radiotherapy Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2008-12", "PrimaryCompletionDate": "2014-12", "Interventions": [ { "Name": "IMRT Technique", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "IMRT and accelerated hypofractionation technique", "Type": "RADIATION", "Description": "Intervention is the technique and accelerated fractionation used to treat GBM", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "neo-adjuvant TMZ followed by accelerated hypofractionated EBRT", "Type": "RADIATION", "Description": "Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide and Accelerated Hypofractionation RT", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "McGill University Health Centre/Research Institute of the McGill University Health Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04541082", "BriefTitle": "Phase I Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms", "OfficialTitle": "A First-in-human Phase I Single-agent Dose-escalation, Food Effect and Dose Expansion Study of Oral ONC206 in Recurrent and Rare Primary Central Nervous System Neoplasms", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-10-26", "PrimaryCompletionDate": "2026-07", "Interventions": [ { "Name": "ONC206", "Type": "DRUG", "Description": "ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jazz Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03075514", "BriefTitle": "Ketogenic Diets as an Adjuvant Therapy in Glioblastoma", "OfficialTitle": "Ketogenic Diets as an Adjuvant Therapy in Glioblastoma: A Randomised Pilot Trial", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-04-01", "PrimaryCompletionDate": "2019-03-05", "Interventions": [ { "Name": "MKD", "Type": "OTHER", "Description": "Modified ketogenic diet", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MCT", "Type": "OTHER", "Description": "Medium chain triglyceride ketogenic diet", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Liverpool", "LeadSponsorClass": "OTHER", "Collaborators": [ "Walton Centre NHS Foundation Trust", "Vitaflo International, Ltd" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02942264", "BriefTitle": "Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma", "OfficialTitle": "Phase I Trial of Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-12-14", "PrimaryCompletionDate": "2020-08-26", "Interventions": [ { "Name": "Zotiraciclib (TG02)", "Type": "DRUG", "Description": "Phase I: Two treatment arms and several dose levels are planned; In the maximum tolerated dose (MTD) finding part, Temozolomide (TMZ) with two alternate schedules (dose dense (dd) and metronomic (mn) in combination with Zotiraciclib (TG02) will be administered;\n\n--A cohort extension of both arms will be performed at each MTD and the treatment arm with a better progression free survival at 4 months (PFS4) will be selected for the combination treatment arm for Phase II; Patients will be randomized between two competing treatment arms: (winner of dd vs mn) TMZ + Zotiraciclib (TG02) versus dd/mn TMZ alone using a Bayesian clinical trial design. The dosage for the combination arm will be derived from the MTD determined in the Phase I component of the study.", "OtherNames": [ "TG02" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Phase I: In the maximum tolerated dose (MTD) finding part, Temozolomide (TMZ) with two alternate schedules (dose dense (dd) and metronomic (mn) in combination with Zotiraciclib (TG02) will be administered; A cohort extension of both arms will be performed at each MTD and the treatment arm with a better progression free survival at 4 months (PFS4) will be selected for the combination treatment arm for Phase II; Patients will be randomized between two competing treatment arms: (\"winner\" of dd vs mn) TMZ + Zotiraciclib (TG02) versus dd/mn TMZ alone using a Bayesian clinical trial design.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01316809", "BriefTitle": "AZD8055 for Adults With Recurrent Gliomas", "OfficialTitle": "Phase I Trial of AZD8055, An Oral MTOR Kinase Inhibitor, for Adults With Recurrent Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-03-04", "PrimaryCompletionDate": "2014-04-14", "Interventions": [ { "Name": "AZD8055", "Type": "DRUG", "Description": "Patients will start at 120 mg once daily", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00006093", "BriefTitle": "EMD 121974 in Treating Patients With Progressive or Recurrent Glioma", "OfficialTitle": "A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-09", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "cilengitide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01498328", "BriefTitle": "A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma", "OfficialTitle": "A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2015-04", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Rindopepimut (CDX-110) with GM-CSF", "Type": "DRUG", "Description": "Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "KLH", "Type": "DRUG", "Description": "KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Celldex Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05033587", "BriefTitle": "Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma.", "OfficialTitle": "AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma: a Prospective, Open-label Single-arm, Exploratory Trial.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-09", "PrimaryCompletionDate": "2023-05-01", "Interventions": [ { "Name": "Anlotinib", "Type": "DRUG", "Description": "Anlotinib a multi-target receptor tyrosine kinase inhibitor.", "OtherNames": [ "Anlotinib Hydrochloride Capsules" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "AK105", "Type": "DRUG", "Description": "AK105 is a humanized monoclonal antibody that specifically binds to PD-1.", "OtherNames": [ "Penpulimab Injection" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "The radiotherapy regimen delivered 2.0Gy once a day, five days a week to a total dose of 60Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School", "LeadSponsorClass": "OTHER", "Collaborators": [ "Chia Tai Tianqing Pharmaceutical Group Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03995706", "BriefTitle": "Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0", "OfficialTitle": "A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2019-07-17", "PrimaryCompletionDate": "2022-06-03", "Interventions": [ { "Name": "Sacituzumab Govitecan", "Type": "DRUG", "Description": "All 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "The University of Texas Health Science Center at San Antonio", "LeadSponsorClass": "OTHER", "Collaborators": [ "Gilead Sciences" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04922723", "BriefTitle": "Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma", "OfficialTitle": "A Study of Radiation/Temozolomide and Immunotherapy With Daratumumab to Improve Antitumor Efficacy in Glioblastoma (PRIDE).", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-10-03", "PrimaryCompletionDate": "2026-02", "Interventions": [ { "Name": "Daratumumab", "Type": "DRUG", "Description": "Daratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy.", "OtherNames": [ "Darzalex" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "West Virginia University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02967380", "BriefTitle": "Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain Metastases", "OfficialTitle": "Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2011-12-14", "PrimaryCompletionDate": "2014-10-14", "Interventions": [ { "Name": "Dynamic Contrast-Enhanced Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo DCE-MRI", "OtherNames": [ "DCE MRI", "DCE-MRI", "DYNAMIC CONTRAST ENHANCED MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Gadobenate Dimeglumine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Gd-BOPTA", "MultiHance" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Gadobutrol", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BAY86-4875", "Gadograf", "Gadovist", "Protovis", "ZK 135079" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Gadopentetate Dimeglumine", "Type": "RADIATION", "Description": "Given IV", "OtherNames": [ "Gadolinium DTPA", "Gd-DTPA", "Magnevist", "Meglumine Gadopentetate", "SH L 451 A", "ZK 93035" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of Southern California", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05698524", "BriefTitle": "A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma", "OfficialTitle": "A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-06-26", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "PCI 24781", "Type": "DRUG", "Description": "Participants will take PCI-24781/Abexinostat on days 1 - 4, 8 - 11, and 15 - 18 of each 28-day cycle.", "OtherNames": [ "Abexinostat" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Participants will receive temozolomide at a dose of 50 mg/mg2, taken by mouth once daily.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Nebraska", "LeadSponsorClass": "OTHER", "Collaborators": [ "Xynomic Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00004113", "BriefTitle": "Temozolomide in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase II Study of Temozolomide (SCH 52365, Temodal(R)) for the Treatment of Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-06", "PrimaryCompletionDate": "2001-10", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00948389", "BriefTitle": "Study of CCNU (Lomustine) Plus Dasatinib in Recurrent Glioblastoma (GBM)", "OfficialTitle": "Randomized Phase II of Lomustine Versus Lomustine-Dasatinib in Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-10", "PrimaryCompletionDate": "2011-05", "Interventions": [ { "Name": "Dasatinib", "Type": "DRUG", "Description": "Tablets, Oral, 100 mg, Once or Twice daily (depending on safety cohort), Until progression or toxicity", "OtherNames": [ "BMS-354825" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Tablets, Oral, 110 mg/m², Every 6 weeks, until progression or toxicity", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Bristol-Myers Squibb", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "European Organisation for Research and Treatment of Cancer - EORTC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00875433", "BriefTitle": "Afatinib (BIBW 2992) QTcF Trial in Patients With Relapsed or Refractory Solid Tumours", "OfficialTitle": "Phase II Open Label Trial to Assess the Efficacy and the Impact on QTcF of Continuous Oral BIBW 2992 at a Daily Dose of 50mg in Patients With Relapsed or Refractory Solid Tumours Including Patients With Brain Metastases and Those With Glioblastoma Not Amenable to Other Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-03", "PrimaryCompletionDate": "2011-04", "Interventions": [ { "Name": "BIBW 2992", "Type": "DRUG", "Description": "patients to receive continuous oral daily dosing of BIBW 2992", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Boehringer Ingelheim", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00591058", "BriefTitle": "Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma", "OfficialTitle": "A Phase I Dose Escalation Study Evaluating the Safety and Biologically Active Dose of TM-601 Based on Perfusion MRI Imaging Criteria in Patients With Progressive and/or Recurrent Malignant Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2008-02", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "TM-601", "Type": "DRUG", "Description": "TM-601, administered intravenously (IV), once/week for 3 weeks", "OtherNames": [ "Chlorotoxin (Synthetic)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "TransMolecular", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00548938", "BriefTitle": "Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM", "OfficialTitle": "A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "Gliadel wafer", "Type": "DRUG", "Description": "Implanted at surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "During External Beam Radiation", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "External Beam Radiation Therapy", "Type": "RADIATION", "Description": "60 Gy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Methodist Healthcare", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04725214", "BriefTitle": "Anlotinib Combined With STUPP for MGMT Nonmethylated Glioblastoma", "OfficialTitle": "Anlotinib Combined With STUPP Protocol as First-line Regimen for MGMT Nonmethylated Glioblastoma: a Multicenter, Open-label, Single-arm, Phase II Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-01-15", "PrimaryCompletionDate": "2022-12", "Interventions": [ { "Name": "Anlotinib", "Type": "DRUG", "Description": "Anlotinib With STUPP Regimen", "OtherNames": [ "temozolomide capsule" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01310855", "BriefTitle": "Cediranib Maleate With or Without Gefitinib in Treating Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "Multi-Center, Randomized, Double-Blind Phase II Study Comparing Cediranib (AZD2171) Plus Gefitinib (Iressa, ZD1839) With Cediranib Plus Placebo in Subjects With Recurrent/Progressive Glioblastoma (DORIC Trial)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2013-05", "Interventions": [ { "Name": "cediranib maleate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "gefitinib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00069940", "BriefTitle": "Vaccine Therapy and Sargramostim in Treating Patients With Sarcoma or Brain Tumor", "OfficialTitle": "A Phase I Study Of Vaccination With Telomerase Peptide Plus GM-CSF", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2000-12", "PrimaryCompletionDate": "2006-08", "Interventions": [ { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "TERT" ], "classes": [] } }, { "Name": "telomerase: 540-548 peptide vaccine", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "TERT" ], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "TERT" ], "classes": [] } }, { "NCTId": "NCT03980249", "BriefTitle": "Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells", "OfficialTitle": "A Pilot Study: Evaluating the Anti-Cancer Effects of Carvedilol With TTFields and Standard of Care in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells", "OverallStatus": "WITHDRAWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-09", "PrimaryCompletionDate": "2021-12", "Interventions": [ { "Name": "Carvedilol", "Type": "DRUG", "Description": "Carvedilol: Start at 6.26 mg PO twice daily for 1-2 weeks and if tolerated, will be increased to 12.5 mg PO twice daily for 6 cycles as tolerated.", "OtherNames": [ "Coreg" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "West Virginia University", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd.", "West Virginia Clinical and Translational Science Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00008008", "BriefTitle": "Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma", "OfficialTitle": "CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1997-09", "PrimaryCompletionDate": "2005-06", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "bone marrow ablation with stem cell support", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Herbert Irving Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00085540", "BriefTitle": "FR901228 in Treating Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I-II Trial of Depsipeptide in Patients With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "depsipeptide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "FK228", "FR901228", "Istodax", "romidepsin" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05052957", "BriefTitle": "hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)", "OfficialTitle": "Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-01-20", "PrimaryCompletionDate": "2026-06-01", "Interventions": [ { "Name": "P140K-MGMT", "Type": "BIOLOGICAL", "Description": "Ex Vivo Cultured P140K MGMT CD34+ Cells. The transduced cells are a biological product and production is detailed in the Cellular Therapy Lab standard operating procedures and IND 14099", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": "O6BG is a low molecular-weight purine analog which selectively and irreversibly inactivates the DNA-repair enzyme, O6- alkylguanine DNA-alkyltransferase.", "OtherNames": [ "BG" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Photon Based Radiotherapy", "Type": "RADIATION", "Description": "Standard of care, photon-based radiotherapy (60Gy in 30 fractions) will be performed in both arms without concomitant TMZ between to 6 weeks post-operatively. Radiotherapy will be performed at UH-SCC.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Temozolomide is not directly active but undergoes rapid non-enzymatic conversion at physiologic pHto the reactive compoundMTIC. The cytotoxicity of MTIC is thought to be primarily due to alkylationof DNA. Alkylation (methylation) occurs mainly at the O6 and N7 positions of guanine", "OtherNames": [ "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Filgrastim", "Type": "DRUG", "Description": "Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. Endogenous filgrastim is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells, which regulates the production of neutrophils within the bone marrow.", "OtherNames": [ "G-CSF,Granulocyte-Colony Stimulating Factor" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": "BCNU is a lipid soluble agent which has alkylating properties, plus an isocyanate metabolite which interferes with DNA and RNA synthesis.", "OtherNames": [ "BCNU,bis-chloronitrosourea" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Leland Metheny", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07346144", "BriefTitle": "Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma", "OfficialTitle": "A Phase I/II Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2026-03", "PrimaryCompletionDate": "2030-03", "Interventions": [ { "Name": "TGX-007", "Type": "DRUG", "Description": "TGX-007 administered as single intratumoural injection", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Valaciclovir", "Type": "DRUG", "Description": "Oral valaciclovir administered 3 times daily for 14 - 21 days", "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Trogenix ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05911230", "BriefTitle": "Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases", "OfficialTitle": "Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases- AiD GLIO Pilot Trial", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-11-24", "PrimaryCompletionDate": "2025-11", "Interventions": [ { "Name": "Advanced diffusion-weighted MRI (ADW-MRI)", "Type": "DIAGNOSTIC_TEST", "Description": "An advanced diffusion weighted MRI-sequence will be performed in addition to the routine MRI-diagnostics. This will require the patient to be scanned for additional 30 minutes in a separate MRI-scanner. This technique offers the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the CNS. In the case of surgical resection, the histopathological findings will be correlated to the findings of the ADW-MRI.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Basel, Switzerland", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01961934", "BriefTitle": "C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression", "OfficialTitle": "Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "Sodium Acetate C11 PET/CT Imaging", "Type": "DRUG", "Description": null, "OtherNames": [ "Carbon 11 Acetate", "C11 Acetate", "AC-PET", "PET Imaging with Acetate C11" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Phoenix Molecular Imaging", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004028", "BriefTitle": "Carmustine in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1996-09", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00574964", "BriefTitle": "Gliadel Wafers and Temodar in the Treatment of Glioblastoma Multiforme", "OfficialTitle": "Phase II Treatment of Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme Treated With Gliadel Wafers, Surgery and Limited Field Radiation Plus Concomitant Temozolomide Followed by Temozolomide", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2005-10", "PrimaryCompletionDate": "2007-11", "Interventions": [ { "Name": "Gliadel Wafer, Temodar and Radiotherapy", "Type": "OTHER", "Description": "Given concurrently starting 10-30 days after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Iowa", "LeadSponsorClass": "OTHER", "Collaborators": [ "Eisai Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06551909", "BriefTitle": "Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)", "OfficialTitle": "Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-08-31", "PrimaryCompletionDate": "2026-08-31", "Interventions": [ { "Name": "Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost", "Type": "RADIATION", "Description": "Patients with Glioblastoma will receive neoadjuvant stereotactic radiotherapy to Planning Target Volume (PTV) to 30 Gy in 5 fractions, and a Simultaneous Integrated Boost delivering 35-50 GY to GTV. Patients will be divided into groups of 5 and will receive (in the absence of 2 G4 toxicities per group), the following dose levels: 35-40-42.5-45-47.5 and 50 Gy. Standard Temozolomide chemotherapy will be prescribed after surgery.", "OtherNames": [ "Ultrahypofractionated Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "IRCCS San Raffaele", "LeadSponsorClass": "OTHER", "Collaborators": [ "European Commission", "Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale", "Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Moscati (Avellino)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02270034", "BriefTitle": "Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase Ib, Open-label, Multicenter, Dose-escalation Study Followed by an Extension Phase to Evaluate the Safety and Activity of the Combination of Crizotinib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-08-13", "PrimaryCompletionDate": "2020-10-26", "Interventions": [ { "Name": "Crizotinib", "Type": "DRUG", "Description": "Crizotinib is added to Stupp method", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK", "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "MET" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01109095", "BriefTitle": "CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM", "OfficialTitle": "Administration of HER2 Chimeric Antigen Receptor Expressing CMV-Specific Cytotoxic T Cells Ins Patients With Glioblastoma Multiforme (HERT-GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2014-06", "Interventions": [ { "Name": "HER.CAR CMV-specific CTLs", "Type": "BIOLOGICAL", "Description": "HER2.CAR CMV-specific CTLs will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line with a minimum 20g cannula. The patient will get one of the following doses:\n\n* 1 x 10\\^6/m\\^2\n* 3 x 10\\^6/m\\^2\n* 1 x 10\\^7/m\\^2\n* 3 x 10\\^7/m\\^2\n* 1 x 10\\^8/m\\^2", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Baylor College of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "The Methodist Hospital Research Institute", "Center for Cell and Gene Therapy, Baylor College of Medicine" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01290939", "BriefTitle": "Bevacizumab and Lomustine for Recurrent GBM", "OfficialTitle": "Phase III Trial Exploring the Combination of Bevacizumab and Lomustine in Patients With First Recurrence of a Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2011-10", "PrimaryCompletionDate": "2015-10", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "lomustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "DNA methylation analysis", "Type": "GENETIC", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Epigenetic modifier" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "cognitive assessment", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "quality-of-life assessment", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Hoffmann-La Roche" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Epigenetic modifier" ] } }, { "NCTId": "NCT01666600", "BriefTitle": "NOA-12: BIBF1120 and R-RT in Glioblastoma", "OfficialTitle": "A Phase I/II, Randomized, Open-label, Multi-centre Study of BIBF1120 + Reirradiation (R-RT) Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-08", "PrimaryCompletionDate": "2017-03", "Interventions": [ { "Name": "BIBF 1120", "Type": "DRUG", "Description": "BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiotherapy", "Type": "RADIATION", "Description": "36 Gy, 2 Gy / fraction, 18 fractions", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Prof. Dr. Wolfgang Wick", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00777153", "BriefTitle": "Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma", "OfficialTitle": "A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2008-10", "PrimaryCompletionDate": "2010-04", "Interventions": [ { "Name": "Cediranib", "Type": "DRUG", "Description": "30 mg/day, oral, until progression", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Cediranib", "Type": "DRUG", "Description": "20 mg/day, oral, until progression", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine Chemotherapy", "Type": "DRUG", "Description": "110 mg/m2 / Q6W, oral, until progression", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo Cediranib", "Type": "DRUG", "Description": "Oral, until progression", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AstraZeneca", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05929495", "BriefTitle": "Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma", "OfficialTitle": "Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-02-12", "PrimaryCompletionDate": "2026-01-01", "Interventions": [ { "Name": "Metformin", "Type": "DRUG", "Description": "The investigator will identify potential participants and confirm the diagnosis of GBM. Subjects will be screened within 6 weeks before starting treatment.\n\nTreatment will involve:\n\n* Administration of the standard or partial Stupp protocol (Radiotherapy + Temozolomide) in combination with Metformin for 6 weeks,\n* Treatment with only Metformin for 4 weeks;\n* Resumption of adjuvant TMZ + Metformin treatment continuously until the end of the enrollment period.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Milano Bicocca", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02189109", "BriefTitle": "The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma", "OfficialTitle": "A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2017-08-31", "Interventions": [ { "Name": "NVX-108", "Type": "DRUG", "Description": "0.2% emulsion administered i.v.", "OtherNames": [ "Dodecafluoropentane" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NuvOx LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "The Alfred" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01119599", "BriefTitle": "RO4929097, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Malignant Glioma", "OfficialTitle": "Phase 1 Trial of RO4929097 in Combination With Standard Radiotherapy and Temozolomide for Newly Diagnosed Malignant Glioma: A Pharmacokinetic and Pharmacodynamic Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-05", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3-D conformal radiation therapy", "OtherNames": [ "3-dimensional radiation therapy", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Gamma-Secretase Inhibitor RO4929097", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "RO4929097" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo IMRT", "OtherNames": [ "IMRT", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temodal", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02039778", "BriefTitle": "Stem Cell Radiotherapy and Temozolomide for Newly Diagnosed High-grade Glioma", "OfficialTitle": "STRONG Trial - Stem Cell Radiotherapy (ScRT) and Temozolomide for Newly Diagnosed High-grade Glioma (HGG): A Prospective, Phase I/II Trial", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2013-12", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "Stem Cell Radiotherapy (ScRT) and Temozolomide", "Type": "RADIATION", "Description": "Stem Cell Radiotherapy (ScRT) and Temozolomide:\n\nThe postoperative surgical bed + edema + margin \\& the ipsilateral subventricular zone (contoured as a 5mm rim of tissue around the ipsilateral lateral ventricles) will be included within the initial target volume and treated to 46 Gy in 23 fractions. After 46 Gy, the conedown or boost volume (surgical cavity + margin) will be treated to a total of 60 Gy, with seven additional fractions of 2 Gy each (14Gy boost dose).\n\nTemozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays).", "OtherNames": [ "Intensity Modulated Radiation Therapy (IMRT)", "Temozolomide", "Stem Cell Radiotherapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Beth Israel Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "St. Luke's-Roosevelt Hospital Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03022578", "BriefTitle": "Laser Interstitial Thermal Therapy and Lomustine in Treating Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma", "OfficialTitle": "Phase II Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2017-11-07", "PrimaryCompletionDate": "2021-02-16", "Interventions": [ { "Name": "Laser Interstitial Thermal Therapy", "Type": "PROCEDURE", "Description": "Undergo LITT", "OtherNames": [ "LITT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea", "1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-", "Belustin", "Belustine", "CCNU", "Cecenu", "CeeNU", "Chloroethylcyclohexylnitrosourea", "Citostal", "Gleostine", "Lomeblastin", "Lomustinum", "Lucostin", "Lucostine", "N-(2-Chloroethyl)-N''-cyclohexyl-N-nitrosourea", "Prava", "RB-1509", "WR-139017" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02841332", "BriefTitle": "Multimodal Imaging Analysis During Treatment With Bevacizumab in Patients With Recurrent Glioblastoma", "OfficialTitle": "Multimodal Imaging Analysis of Tissue Changes Occurring During Treatment With Antiangiogenic (Bevacizumab) in Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "F-MISO", "Type": "DRUG", "Description": "The fluoro-misonidazole is a positron emission tomography tracer (labeled with Fluorine-18)-specific hypoxia. This compound penetrates into cells where it is reduced by a nitroreductase enzyme. It is rapidly regenerated by reoxidation when the cell is properly oxygenated. This metabolite can accumulate in viable hypoxic cells (necrotic cells that can provide initial reduction reaction of F-MISO).\n\nMoreover, the fixing of this tracer appears to be independent of blood flow. The advantage of this technique is to provide a direct image of hypoxic cells by directly targeting under stress hypoxic.", "OtherNames": [ "fluoro-misonidazole" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Cerebral magnetic resonance imagery", "Type": "OTHER", "Description": "During the pre-therapeutic imagery session :\n\n* Morphological magnetic resonance imagery ( axial T1 sequence axial T1 post contrast , Flair Axial )\n* magnetic resonance imagery spectroscopy sequence\n* Perfusion magnetic resonance imagery sequence\n* Diffusion magnetic resonance imagery sequence", "OtherNames": [ "Cerebral MRI" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Clinical examination", "Type": "OTHER", "Description": "During the examination, the following parameters will be checked :\n\n* Neurological examination\n* Corticotherapy prescribed\n* General status of patient (world health organization score)\n* Weight and height\n* Control of arterial pressure\n* Chirurgical and medical history\n* Concomitant treatment", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University Hospital, Toulouse", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04047706", "BriefTitle": "Nivolumab, BMS-986205, and Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Combination of Checkpoint Inhibition and IDO1 Inhibition Together With Standard Radiotherapy or Chemoradiotherapy in Newly Diagnosed Glioblastoma. A Phase 1 Clinical and Translational Trial", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-08-13", "PrimaryCompletionDate": "2027-02-15", "Interventions": [ { "Name": "IDO1 Inhibitor BMS-986205 25mg", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BMS 986205", "BMS-986205", "BMS986205", "IDO-1 Inhibitor BMS-986205", "Indoleamine-pyrrole 2,3-Dioxygenase Inhibitor BMS-986205", "ONO-7701" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BMS-936558", "MDX-1106", "NIVO", "ONO-4538", "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "Irradiated", "irradiation", "Radiation", "Radiotherapeutics", "RADIOTHERAPY", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "IDO1 Inhibitor BMS-986205 50 mg", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BMS 986205", "BMS-986205", "BMS986205", "IDO-1 Inhibitor BMS-986205", "Indoleamine-pyrrole 2,3-Dioxygenase Inhibitor BMS-986205", "ONO-7701" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "IDO1 Inhibitor BMS-986205 100 mg", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BMS 986205", "BMS-986205", "BMS986205", "IDO-1 Inhibitor BMS-986205", "Indoleamine-pyrrole 2,3-Dioxygenase Inhibitor BMS-986205", "ONO-7701" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03739333", "BriefTitle": "Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.", "OfficialTitle": "Early Diagnosis of Pseudoprogression Using 11C-Methionine PET-MRI After Concomitant Radiochemotherapy Treatment for Glioblastoma.", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2019-02-26", "PrimaryCompletionDate": "2020-02-26", "Interventions": [ { "Name": "11C-Methionine PET-MRI", "Type": "OTHER", "Description": "Implementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Hospices Civils de Lyon", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05954858", "BriefTitle": "Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma", "OfficialTitle": "Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-06-29", "PrimaryCompletionDate": "2026-06-30", "Interventions": [ { "Name": "Tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap to bypass the blood brain barrier (BBB)", "Type": "PROCEDURE", "Description": "Surgical tissue autograft of pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.", "OtherNames": [ "surgical tissue flap", "tissue autograft" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00693095", "BriefTitle": "Evaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer", "OfficialTitle": "Evaluation of Recovery From Drug-Induced Lymphopenia Using Cytomegalovirus-specific T-cell Adoptive Transfer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-09", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "CMV-ALT + CMV-DCs", "Type": "BIOLOGICAL", "Description": "CMV-ALT (3 X 10e7) with CMV-DCs (2 X 10e7)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CMV-ALT + Saline", "Type": "BIOLOGICAL", "Description": "CMV-ALT (3 X 10e7) with Saline", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "John Sampson", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02253212", "BriefTitle": "Safety of BBB Opening With the SonoCloud", "OfficialTitle": "A Study to Evaluate the Safety of Transient Opening of the Blood-Brain Barrier by Low Intensity Pulsed Ultrasound With the SonoCloud Implantable Device in Patients With Recurrent Glioblastoma Before Chemotherapy Administration", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-07", "PrimaryCompletionDate": "2018-07", "Interventions": [ { "Name": "SonoCloud", "Type": "DEVICE", "Description": "SonoCloud : dose escalation", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05938387", "BriefTitle": "Safety and Tolerability of CVGBM in Adults with Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma", "OfficialTitle": "A Phase 1 Dose-Finding Study to Evaluate Safety and Tolerability of CVGBM in Patients with Surgically Resected Glioblastoma (GBM) or Astrocytoma with a Molecular Signature of Unmethylated Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-06-01", "PrimaryCompletionDate": "2026-02-04", "Interventions": [ { "Name": "CV09050101 mRNA vaccine (CVGBM) 12 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "CV09050101 mRNA vaccine (CVGBM) 25 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "CV09050101 mRNA vaccine (CVGBM) 50 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "CV09050101 mRNA vaccine (CVGBM) 100 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "CV09050101 mRNA vaccine RDE 100 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "CV09050101 mRNA vaccine (CVGBM) 6 μg", "Type": "BIOLOGICAL", "Description": "CVGBM will be administered as an IM injection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "CureVac", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT05383872", "BriefTitle": "Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors", "OfficialTitle": "A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 Using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2022-08-08", "PrimaryCompletionDate": "2025-02-21", "Interventions": [ { "Name": "Focused Ultrasound (Exablate Model 4000)", "Type": "DEVICE", "Description": "BBB opening via Exablate Type 2 system with microbubble resonators and drawing blood before and after opening", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00817284", "BriefTitle": "Bevacizumab and Irinotecan or Bevacizumab and Temozolomide With Concomitant Radiotherapy for Primary Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Randomized Phase II Trial With Bevacizumab, Irinotecan and Cerebral Radiotherapy Versus Bevacizumab, Temozolomide and Cerebral Radiotherapy as First Line Treatment for Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-11", "PrimaryCompletionDate": "2011-11", "Interventions": [ { "Name": "bevacizumab and Irinotecan and radiotherapy", "Type": "DRUG", "Description": "* Bevacizumab 10 mg/kg is administered on days 1 and 15.\n* Irinotecan:\n* Irinotecan 125 mg/m2 is administered on days 1 and 15 to patients NOT receiving enzyme-inducing antiepileptic drugs (EIAED).\n* Irinotecan 340 mg/m2 is administered on days 1 and 15 to patients receiving EIAEDs.\n* During concomitant chemoradiotherapy, bevacizumab and irinotecan are given in the same doses and schedules as before and after chemoradiotherapy.\n\nRadiotherapy is delivered during 3rd and 4th cycle of chemotherapy and consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday to Friday) over a period of six weeks for a total dose of 60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab and Temozolomide and radiotherapy", "Type": "DRUG", "Description": "Bevacizumab 10 mg/kg is administered on days 1 and 15. Temozolomide dosing before start concomitant chemoradiotherapy: 150 mg/m2/day on days 1-5 during the first 28 days treatment cycle, then 200 mg/m2/day on the subsequent cycles until radiotherapy.\n\nTemozolomide administered concomitantly with the radiotherapy: Temozolomide 75 mg/m2/day for 7 days per week is administered on each day of radiotherapy.\n\nAfter completed chemoradiotherapy, temozolomide is dosed and administered as it was prior to start chemoradiotherapy, i.e. temozolomide 200 mg/m2/day on days 1-5 out of a 28 days schedule, taking into consideration any previous dose-reductions already made.\n\nRadiotherapy is delivered during 3rd and 4th cycle of chemotherapy and consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday to Friday) over a period of six weeks for a total dose of 60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Ulrik Lassen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04003649", "BriefTitle": "IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM", "OfficialTitle": "A Phase 1 Study to Evaluate IL13Rα2-Targeted Chimeric Antigen Receptor (CAR) T Cells Combined With Checkpoint Inhibition for Patients With Resectable Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-12-02", "PrimaryCompletionDate": "2026-05-26", "Interventions": [ { "Name": "IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells", "Type": "BIOLOGICAL", "Description": "Given ITV/ITC", "OtherNames": [ "IL13 [EQ]BBzeta/truncated CD19[t]+ Naive and Memory T Cells", "IL13 [EQ]BBzeta/truncated CD19[t]+ TN/MEM Cells", "IL13Ra2-specific-hinge-optimized-4-1BB-CAR/truncated CD19-expressing Autologous TN/MEM Lymphocytes" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Ipilimumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody", "BMS-734016", "MDX-010", "MDX-CTLA4", "Yervoy" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "BMS-936558", "MDX-1106", "NIVO", "ONO-4538", "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Bristol-Myers Squibb", "Gateway for Cancer Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "NCTId": "NCT04225039", "BriefTitle": "Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma", "OfficialTitle": "A Phase II Study of the Anti-GITR Agonist INCAGN1876 and the PD-1 Inhibitor INCMGA00012 in Combination With Stereotactic Radiosurgery in Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-06-23", "PrimaryCompletionDate": "2022-09-08", "Interventions": [ { "Name": "INCMGA00012", "Type": "DRUG", "Description": "500mg IV neoadjuvant treatment; 500 mg adjuvant treatment", "OtherNames": [ "PD-1 inhibitor", "PD1" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "INCAGN01876", "Type": "DRUG", "Description": "300mg IV neoadjuvant treatment; 300 mg adjuvant treatment", "OtherNames": [ "Anti-GITR agonist", "GITR" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "SRS", "Type": "DRUG", "Description": "administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).", "OtherNames": [ "stereotactic radiosurgery" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Brain surgery", "Type": "PROCEDURE", "Description": "maximal safe surgical resection of the tumor.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "University of Pennsylvania", "LeadSponsorClass": "OTHER", "Collaborators": [ "Incyte Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT02175745", "BriefTitle": "18F-FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly-Diagnosed or Recurrent Gliomas", "OfficialTitle": "18F-FDOPA PET/CT or PET/MRI in Patients With Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2014-12", "PrimaryCompletionDate": "2015-08", "Interventions": [ { "Name": "18F-fluoro-dihydroxyphenylalanine", "Type": "DRUG", "Description": "Administered intravenously (IV)", "OtherNames": [ "(18)F-FDOPA", "18F-6-L-fluorodopa", "18F-DOPA", "18F-FDOPA", "Fluorine F-18 fluorodopa" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron emission tomography (PET)", "Type": "PROCEDURE", "Description": "Component of an 18F-FDOPA PET/CT or PET/MRI scan", "OtherNames": [ "FDG-PET", "PET", "PET scan", "tomography, emission computed" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Computed tomography (CT)", "Type": "PROCEDURE", "Description": "Component of an 18F-FDOPA PET/CT", "OtherNames": [ "tomography, computed", "CT scan" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Component of an 18F-FDOPA PET/MRI", "OtherNames": [ "MRI scan", "NMR imaging", "NMRI", "nuclear magnetic resonance imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Erik Mittra", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03681028", "BriefTitle": "Feasibility of Individualized Therapy for Recurrent Glioblastoma", "OfficialTitle": "Pilot Study Testing Feasibility of Individualized Therapy for Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-12-19", "PrimaryCompletionDate": "2023-11-30", "Interventions": [ { "Name": "Individualized therapy", "Type": "DRUG", "Description": "1. For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract.\n2. When a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy.\n3. When a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jennifer Clarke", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01923922", "BriefTitle": "CT Perfusion in the Prognostication of Cerebral High Grade Glioma", "OfficialTitle": "CT Perfusion in the Prognostication of Cerebral High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-09-09", "PrimaryCompletionDate": "2019-10-22", "Interventions": [ { "Name": "CT Perfusion", "Type": "RADIATION", "Description": "The CT perfusion scan will be performed on a multi-detector CT scanner at the time of routine preoperative neuronavigation imaging. A non-contrast CT head scan will be acquired to localize the tumour. Four 5 mm thick slices will be selected at the level of the tumour. Multiple images will be acquired at each levels starting 5 sec after the injection of 50 cc of non-ionic iodinated contrast media at a rate of 4 cc/sec. The acquisition parameters will be 80 kVp and 100 mA. The images will be acquired every second for a total of 110 sec. The post- processing will be performed and parameters will be calculated using regions of interest in the areas of tumour showing the highest perfusion values. Another region of interest will be placed in the contralateral normal looking white matter.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Nova Scotia Health Authority", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06649851", "BriefTitle": "G-CSF After Chemo-radiation in Patients With Glioblastoma", "OfficialTitle": "A Phase 2 Randomized Open-Label Pilot Study of Granulocyte Colony Stimulating Factor (G-CSF) to Preserve Brain Structure and Function Following Standard Chemoradiation in Patients With Newly Diagnosed MGMT-Methylated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-04-02", "PrimaryCompletionDate": "2027-01-31", "Interventions": [ { "Name": "Granulocyte Colony Stimulating Factor (G-CSF)", "Type": "DRUG", "Description": "Subcutaneously injected study drug; standard target dose of 5-7 µg/kg/d.", "OtherNames": [ "G-CSF", "Filgrastim", "Granix", "Neupogen", "Zarxio" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Radiation Therapy + Temozolomide", "Type": "RADIATION", "Description": "Standard of care chemoradiation is radiation therapy + Temozolomide (TMZ). Chemoradiation (chemo-RT) includes an initial 6-week cycle, followed by a 4-week break, and up to 6 additional cycles of TMZ.", "OtherNames": [ "Chemo-RT", "chemoradiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01632228", "BriefTitle": "A Study of Onartuzumab (MetMAb) in Combination With Bevacizumab Compared to Bevacizumab Alone or Onartuzumab Monotherapy in Participants With Recurrent Glioblastoma", "OfficialTitle": "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-06-29", "PrimaryCompletionDate": "2016-01-21", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Onartuzumab", "Type": "DRUG", "Description": "Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.", "OtherNames": [ "MetMAb, RO5490258" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06757153", "BriefTitle": "Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients", "OfficialTitle": "Clinical Study on the Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2024-12-19", "PrimaryCompletionDate": "2027-08", "Interventions": [ { "Name": "NRG-103", "Type": "DRUG", "Description": "NRG-103 is an oncolytic virus, which can kill GBM cells via three manners.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Zhongnan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04608812", "BriefTitle": "Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection", "OfficialTitle": "A Pilot Study of Intratumorally and Intraparenchymally Administered OS2966 Using Convection-enhanced Delivery in Patients With Recurrent/Progressive High-grade Glioma Undergoing a Clinically-indicated Surgical Resection", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2021-03-02", "PrimaryCompletionDate": "2023-02-27", "Interventions": [ { "Name": "OS2966", "Type": "DRUG", "Description": "OS2966 is a humanized monoclonal antibody antagonizing CD29 (Beta 1 integrin)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gadoteridol", "Type": "DRUG", "Description": "Gadoteridol is a contrast agent which will be added to OS2966 to allow investigators to observe how OS2966 distributes within the brain tumor. Gadoteridol is approved by the FDA for intravenous injection during an MRI scan. It is not approved by the FDA for administration directly into a tumor.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "OncoSynergy, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Infuseon Therapeutics, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00613093", "BriefTitle": "Ph. II Temozolomide + O6-BG in Treatment of Pts w Temozolomide-Resistant Malignant Glioma", "OfficialTitle": "Phase II Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Temodar-Resistant Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-10", "PrimaryCompletionDate": "2006-03", "Interventions": [ { "Name": "Temodar and O6-Benzylguanine (BG)", "Type": "DRUG", "Description": "Objectives of study are to define role of BG in restoring Temodar sensitivity in patients with Temodar-resistant malignant glioma and to further define the toxicity of combination therapy using Temodar + BG. 2 separate strata accrued independently of each other: Stratum 1-patients with glioblastoma multiforme (GBM). Stratum 2-patients with anaplastic glioma (AG).\n\nBG at 120mg/m2 administered intravenously over 1 hour followed immediately by 48-hour infusion at 30mg/m2/24 hours. Temodar 472mg/m2 administered orally, in fasting state, within 60 minutes of end of the 1-hour administration of BG infusion. Treatment cycles may be repeated every 28 days following dose of Temodar from previous cycle.", "OtherNames": [ "Temodar - Temozolomide", "O6-Benzylguanine - O6-BG" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Keryx / AOI Pharmaceuticals, Inc.", "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02770378", "BriefTitle": "A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma", "OfficialTitle": "A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-11", "PrimaryCompletionDate": "2018-10", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients will receive temozolomide at a dose of 20 mg/m² BSA twice daily with start day 1 during induction and treatment cycles", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Aprepitant", "Type": "DRUG", "Description": "Patients will receive aprepitant at a dose of 80 mg p.o. once daily with start day 1 during induction and treatment cycles", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Minocycline", "Type": "DRUG", "Description": "Induction cycle day 3-4: minocycline 50 mg p.o. twice daily from day 19-20; minocycline 100 mg p.o. twice daily during treatment cycle 1-12 (28 days); minocycline 100 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Disulfiram", "Type": "DRUG", "Description": "Induction cycle day 5-6: disulfiram 250 mg p.o. once daily from day 21-22; disulfiram 250 mg p.o. twice daily during treatment cycle 1-12 (28 days); disulfiram 250 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Celecoxib", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 7-8: celecoxib 200 mg p.o. twice daily from day 23-24; celecoxib 400 mg p.o. twice daily during treatment cycle 1-12 (28 days); celecoxib 400 mg p.o.twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Sertraline", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 9-10: sertraline 50 mg p.o. twice daily, day 31-32: sertraline 100 mg p.o. twice daily; treatment cycle 1-12: sertraline 100 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Captopril", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 11-12: captopril 25 mg p.o. twice daily, day 25-26: captopril 50 mg p.o. twice daily; treatment cycle 1-12 (28 days): captopril 50 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Itraconazole", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 13-14: itraconazole 200 mg p.o. once daily day 27-28; itraconazole 200 mg p.o. twice daily; treatment cycle 1-12 (28 days): itraconazole 200 mg p.o.twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Ritonavir", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 15-16: ritonavir 200 mg p.o. once daily, day 29-30: ritonavir 200 mg p.o. twice daily, day 35: ritonavir 400 mg p.o. twice daily; treatment cycle 1-12 (28 days): ritonavir 400 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Auranofin", "Type": "DRUG", "Description": "Induction cycle day 1-35: day 17-18: auranofin 3 mg p.o. once daily, day 33-34 auranofin 3 mg p.o. twice daily; treatment cycle 1-12 auranofin 3 mg p.o. twice daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Ulm", "LeadSponsorClass": "OTHER", "Collaborators": [ "Reliable Cancer Therapies", "Anticancer Fund, Belgium" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04888611", "BriefTitle": "Neoadjuvant PD-1 Antibody Alone or Combined With DC Vaccines for Recurrent Glioblastoma", "OfficialTitle": "Neoadjuvant PD-1 Antibody Alone or Combined With Autologous Glioblastoma Stem-like Cell Antigens-primed DC Vaccines (GSC-DCV) for Patients With Recurrent Glioblastoma：A Phase II, Randomized Controlled, Double Blind Clinical Trial.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-10-26", "PrimaryCompletionDate": "2023-05-01", "Interventions": [ { "Name": "Camrelizumab plus GSC-DCV", "Type": "BIOLOGICAL", "Description": "Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and GSC-DCV IH every 3 weeks in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Camrelizumab plus Placebo", "Type": "BIOLOGICAL", "Description": "Prior to scheduled surgery, patients need to receive Camrelizumab IV (3mg/kg, up to 200mg). After surgery, patients receive Camrelizumab IV (3mg/kg, up to 200mg) and Placebo IH every 3 weeks in the absence of disease progression or unacceptable toxicity.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Jiangsu HengRui Medicine Co., Ltd.", "Shanghai Sunstem Biotechnology Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT00609999", "BriefTitle": "Ph I Dasatinib + Erlotinib in Recurrent MG", "OfficialTitle": "Phase I Study of Dasatinib Plus Erlotinib in Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-01", "PrimaryCompletionDate": "2010-07", "Interventions": [ { "Name": "Erlotinib and Dasatinib", "Type": "DRUG", "Description": "You will begin study drug regimen on day 1 of cycle 1 w Dasatinib. If you are undergoing Dasatinib pharmacokinetic blood analysis, Dasatinib will be taken alone until initial PK assessments are collected. Erlotinib will be begin after initial Dasatinib PK assessments are collected \\& will continue to be administered w Dasatinib on continuous daily dosing schedule. Initial Dasatinib PK assessments will be collected over 24hrs between days 3-7 of cycle 1 \\& at end of cycle 1. If you are not undergoing Dasatinib PK collections you will begin both Dasatinib \\& Erlotinib together on day 1 of cycle 1. Both drugs will be given in continuous daily oral manner. Cycle is defined as Dasatinib \\& Erlotinib given daily for 28 days for purpose of scheduling evaluations.", "OtherNames": [ "Dasatinib", "Erlotinib", "Tarceva", "Sprycel" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02861898", "BriefTitle": "Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-06", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Intra-arterial Cetuximab", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intra-arterial Mannitol", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00402116", "BriefTitle": "Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients", "OfficialTitle": "Phase 1/2 Study of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-09", "PrimaryCompletionDate": "2009-12", "Interventions": [ { "Name": "enzastaurin", "Type": "DRUG", "Description": "Phase 1 - 250 mg Cohort 1 with one dose escalation allowed to 500 mg for Cohort 2, oral, daily, 6 weeks then twelve 28 day cycles\n\nPhase 2 - Phase 1 established dose, oral, daily, 6 weeks then twelve 28 day cycles", "OtherNames": [ "LY317615" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "75 milligrams per meter squared (mg/m\\^2), oral, daily, 6 weeks then 200 mg/m\\^2, oral, daily, twelve 28 day cycles", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "1.8-2.0 Gy x 30 fractions, 5 days/week, for 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University of California, San Francisco" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02343406", "BriefTitle": "Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas", "OfficialTitle": "INTELLANCE-2: ABT-414 Alone or ABT-414 Plus Temozolomide Versus Lomustine or Temozolomide for Recurrent Glioblastoma: A Randomized Phase 2 Study of the EORTC Brain Tumor Group", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-02-17", "PrimaryCompletionDate": "2019-06-24", "Interventions": [ { "Name": "Depatuxizumab mafodotin", "Type": "DRUG", "Description": "Adults: intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m\\^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).", "OtherNames": [ "ABT-414" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Capsules administered orally, 150 mg/m\\^2 on Days 1-5 for the first 28-day cycle, with dose escalation to 200 mg/m\\^2 in subsequent cycles in case of adequate tolerance until one of the treatment withdrawal criteria was met.", "OtherNames": [ "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Capsules administered orally, 110 mg/m\\^2 on Day 1 of every 42-day treatment period. Treatment continued until one of the treatment withdrawal criteria was met, for a maximum of one year.", "OtherNames": [ "Gleostine" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "European Organisation for Research and Treatment of Cancer - EORTC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003409", "BriefTitle": "Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I Dose Escalating Study of the Safety and Tolerability of Gadolinium Texaphyrin as a Radiation Sensitizer in Patients With Primary Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05666349", "BriefTitle": "Reirradiation and Niraparib in Patients With Recurrent Glioblastoma", "OfficialTitle": "Reirradiation (Re-RT) and Niraparib (NIRA) in Patients With Recurrent Glioblastoma (rGBM)", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2023-10-13", "PrimaryCompletionDate": "2023-10-13", "Interventions": [ { "Name": "Niraparib", "Type": "DRUG", "Description": "100 mg, 200 mg, or 300mg oral niraparib once daily.", "OtherNames": [ "Zejula" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Re-irradiation (re-RT)", "Type": "RADIATION", "Description": "Intensity modulated radiotherapy (IMRT)-based re-RT for a total dose of 35 Gy in 10 daily fractions.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "NCTId": "NCT04121455", "BriefTitle": "Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients", "OfficialTitle": "Single-arm, Dose-escalation Phase 1/2 Study of Olaptesed Pegol (NOX-A12) in Combination With Irradiation in Inoperable or Partially Resected First-line Glioblastoma Patients With Unmethylated MGMT Promoter With a Multiple-arm Expansion Group", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-09-12", "PrimaryCompletionDate": "2028-12", "Interventions": [ { "Name": "Olaptesed pegol", "Type": "DRUG", "Description": "Olaptesed pegol continuous i.v. administration", "OtherNames": [ "NOX-A12" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Radiotherapy in weeks 1-6; cumulative dose of 60 Gy in 2 Gy fractions", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab every 2 weeks i.v. infusion", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab every 3 weeks i.v. for 26 weeks", "OtherNames": [ "KEYTRUDA" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "oral treatment according to current SPC", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "TME Pharma AG", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01164189", "BriefTitle": "Bevacizumab in Recurrent Grade II and III Glioma", "OfficialTitle": "Randomized Trial Assessing the Significance of Bevacizumab in Recurrent Grade II and Grade III Gliomas - The TAVAREC Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-02", "PrimaryCompletionDate": "2017-01-19", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab (vial of 400mg/16mL) at a dose of 10 mg/kg bodyweight i.v. in 90 min on day 1 and day 14 of 4 week cycles", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (250, 100, 20 and 5 mg caps) will be administered orally on day 1-5, 150-200 mg/m², and will be repeated every 4 weeks. This will be repeated for up to 12 cycles.", "OtherNames": [ "Temodar", "Temodal", "Temcad" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Hoffmann-La Roche" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00006474", "BriefTitle": "Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma", "OfficialTitle": "Phase I Trial of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) in the Treatment of Patients With Newly Diagnosed (Part 1) or Recurrent/Progressive (Parts 1 and 2) Cerebral Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2001-03", "PrimaryCompletionDate": "2004-08", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01788280", "BriefTitle": "Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab", "OfficialTitle": "Preliminary Assessment of [18F] Fluciclatide (GE [18F]AH111585) in Glioblastoma Multiforme Treated With Bevacizumab", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2018-01", "PrimaryCompletionDate": "2022-01", "Interventions": [ { "Name": "Fluciclitite , PET imaging, and Bevacizumab", "Type": "DRUG", "Description": "\\[18F\\] Fluciclatide and PET imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Utah", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00004080", "BriefTitle": "Gene Therapy in Treating Patients With Recurrent or Progressive Brain Tumors", "OfficialTitle": "Assessment of the Safety and Transduction Efficiency of SCH58500, An Adenoviral Vector p53 Delivery System, to Patients With Recurrent Malignant Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1999-12", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "recombinant adenovirus-p53 SCH-58500", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02895360", "BriefTitle": "Phase 1/2a Study of BAL101553 as 48-hour Infusions in Patients With Advanced Solid Tumors or Recurrent Glioblastoma", "OfficialTitle": "An Open-label Phase 1/2a Study of BAL101553 Administered as Intravenous 48-hour Infusions in Adult Patients With Advanced Solid Tumors or Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-08-24", "PrimaryCompletionDate": "2020-08-07", "Interventions": [ { "Name": "BAL101553", "Type": "DRUG", "Description": "BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2 (study days 15-21)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "BAL101553 at MTD", "Type": "DRUG", "Description": "BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; treatment with maximum tolerated dose (MTD)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Basilea Pharmaceutica", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02038218", "BriefTitle": "Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors", "OfficialTitle": "A Phase II Trial: Safety and Tolerance of Intravenous 4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Malignancies Involving the Central Nervous System", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-09", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "4-Demethyl-4-cholestryloxycarbonylpenclomedine", "Type": "DRUG", "Description": "This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement.\n\nTwo Cohorts of patients will be treated every 21 days with a single infusion of DM-CHOC-PEN as an out-patient:\n\nCohort 1: Patients with liver involvement or history of disease will be treated at a dose of 85.8 mg/m2 and;\n\nCohort 2: Patients without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2.\n\nPatients in both cohorts will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance.", "OtherNames": [ "DM-CHOC-PEN" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "DEKK-TEC, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Tulane University", "Icahn School of Medicine at Mount Sinai", "Detroit Clinical Research Center", "National Cancer Institute (NCI)", "Ochsner Health System", "The University of Texas Health Science Center, Houston" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00715013", "BriefTitle": "Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma Multiforme Prior to and After Secondary Resection: an Open-label Phase I/II Trial.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "Patupilone", "Type": "DRUG", "Description": "Patupilone", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02209376", "BriefTitle": "Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma", "OfficialTitle": "Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2014-11-18", "PrimaryCompletionDate": "2018-04-04", "Interventions": [ { "Name": "CART-EGFRvIII T cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "University of Pennsylvania", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of California, San Francisco" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT01602588", "BriefTitle": "A Randomised Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)", "OfficialTitle": "A Randomised Phase 2 Trial Investigating the Additional Benefit of Hydroxychloroquine(HCQ)to Short Course Radiotherapy (SCRT) in Patients Aged 70 Years and Older With High Grade Gliomas (HGG)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2016-10", "Interventions": [ { "Name": "Hydroxychloroquine", "Type": "DRUG", "Description": "200mg bd from 14 days post surgery until clinical or radiological progression", "OtherNames": [ "HCQ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Short Course radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cancer Research UK" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03233152", "BriefTitle": "A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma.", "OfficialTitle": "A Phase I/II Clinical Trial on the Per-operative Intratumoral Administration of Myeloid Dendritic Cells Plus Ipilimumab and Nivolumab, Followed by Repeated Intracavitary Plus Intravenous Administration of Nivolumab in Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-11-17", "PrimaryCompletionDate": "2026-11-17", "Interventions": [ { "Name": "Ipilimumab (YervoyTM, 50 mg/10 mL solution)", "Type": "DRUG", "Description": "Ipilimumab will be administered by at the end of the neurosurgical resection procedure at a dose of injection of 10 mg (: 2 ml of YervoyTM, 50 mg/10mL vial).\n\nInjections will be performed manually using a 100 μ-liter dispensing syringe. Twenty needle tracks will dispense the ipilimumab solution within the brain tissue lining the resection cavity. The region suspect on preoperative MRI of the brain to be invaded by glioblastoma cells but not amenable to safe resection will be targeted by adjacent needle tracks through which up to 2 cm of depth a volume of 100 μl per needle track will be injected (: in total 20 needle tracks will be performed). This methodology has been applied previously within the context of phase III clinical trials with sitimagene ceradenovec.", "OtherNames": [ "Nivolumab (OpdivoTM, 40 mg/4 mL solution)" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab (OpdivoTM, 40 mg/4mL solution)", "Type": "DRUG", "Description": "First administration of 10 mg of nivolumab by the intravenous route should be administered within 24 hours prior to the planned neurosurgical resection. Administrations of 10 mg nivolumab (OpdivoTM, 40 mg/4mL solution) will be by a 15 minutes intravenous infusion on days 15, 29, 43, 57, and 71 (or up to ± 3 days before or after the scheduled date if necessary).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Autologous CD1c(BDCA-1)+ /CD141(BDCA-3)+ myDC", "Type": "BIOLOGICAL", "Description": "Autologous CD1c(BDCA-1)+/CD141(BDCA-3)+ myDC will be isolated from PBMC obtained from the leukapheresis. These are injected in the neighbouring brain tissue post tumor resection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Universitair Ziekenhuis Brussel", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT04604158", "BriefTitle": "Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients", "OfficialTitle": "IIT2020-13-GRESHAM-ELLY: Evaluating the Effect of a Mobile Audio Companion (Elly) to Reduce Anxiety in Cancer Patients", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2020-12-02", "PrimaryCompletionDate": "2024-05-17", "Interventions": [ { "Name": "Elly Mobile Phone Application", "Type": "BEHAVIORAL", "Description": "The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.", "OtherNames": [ "Elly App" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Gillian Gresham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02974738", "BriefTitle": "A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)", "OfficialTitle": "A Phase 1, Dose-Escalation and Expansion Trial of PT2977, a HIF-2α Inhibitor, in Patients With Advanced Solid Tumors", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2016-12-07", "PrimaryCompletionDate": "2018-01-12", "Interventions": [ { "Name": "Belzutifan", "Type": "DRUG", "Description": "Belzutifan is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis", "OtherNames": [ "PT2977 Tablets, PT-2977, HIF-2α inhibitor, MK-6482", "WELIREG™" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01260506", "BriefTitle": "Single-Arm Open-Label Multicenter Study of VB-111 in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2015-07-23", "Interventions": [ { "Name": "VB-111", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Vascular Biogenics Ltd. operating as VBL Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04661384", "BriefTitle": "Brain Tumor-Specific Immune Cells (IL13Ralpha2-CAR T Cells) for the Treatment of Leptomeningeal Glioblastoma, Ependymoma, or Medulloblastoma", "OfficialTitle": "A Phase 1 Study to Evaluate IL13Rα2-Targeted Chimeric Antigen Receptor (CAR) T Cells for Adult Patients With Leptomeningeal Glioblastoma, Ependymoma or Medulloblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-03-05", "PrimaryCompletionDate": "2025-11-17", "Interventions": [ { "Name": "IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes", "Type": "BIOLOGICAL", "Description": "Given ICV", "OtherNames": [ "Autologous IL13(EQ)BBzeta/CD19t+ TCM-enriched T Cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04157478", "BriefTitle": "Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma", "OfficialTitle": "Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Multicenter Prospective Phase II Study", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-01", "PrimaryCompletionDate": "2022-12", "Interventions": [ { "Name": "Anlotinib Hydrochloride", "Type": "DRUG", "Description": "Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "People's Hospital of Guangxi Zhuang Autonomous Region", "LeadSponsorClass": "OTHER", "Collaborators": [ "First Affiliated Hospital of Guangxi Medical University", "Cancer Hospital of Guangxi Medical University", "Liuzhou Workers' Hospital", "Nanxishan Hospital", "LiuZhou People's Hospital", "Affiliated Hospital of Guilin University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT07274787", "BriefTitle": "Safety And Effectiveness Of NaviFUS System With Bevacizumab In Recurrent Glioblastoma", "OfficialTitle": "An Open Label, Prospective, Pilot Study To Evaluate The Safety And Effectiveness Of The NaviFUS System In Conjunction With A Standard Treatment Regimen Of Bevacizumab (BEV) In Patients With Recurrent Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2026-01-01", "PrimaryCompletionDate": "2028-06-01", "Interventions": [ { "Name": "NaviFUS System", "Type": "DEVICE", "Description": "The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB. The NaviFUS System is indicated for use to enhance the permeability of conventionally administered therapeutic agents into targeted brain tissue to enhance their therapeutic effects.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Lumason", "Type": "DRUG", "Description": "The NaviFUS System is a FUS phased array system intended to transcranially deliver burst-mode ultrasound energy with the concurrent microbubble intravenous administration to temporally and locally open the BBB.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "In this proposed clinical investigation, the NaviFUS System will be used in conjunction with BEV in recurrent GBM patients.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "NaviFUS Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00102648", "BriefTitle": "Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide", "OfficialTitle": "Phase I/Ib Study of Sarasar and Temodar in Patients with Recurrent or Temodar-Refractory Glioblastoma Multiforme", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2004-12-21", "PrimaryCompletionDate": "2025-03-01", "Interventions": [ { "Name": "Lonafarnib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "4-[2-[4-[(11R)-3,10-Dibromo-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]-1-piperidinyl]-2-oxoethyl]-1-piperidinecarboxamide", "Sarasar", "SCH 66336", "SCH-66336", "SCH66336" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003916", "BriefTitle": "Standard Radiation Therapy With or Without Stereotactic Radiation Therapy in Treating Patients With Glioma", "OfficialTitle": "Focal Fractionated Conformal Stereotactic Boost Following Conventional Radiotherapy of High Grade Gliomas: A Randomized Phase III Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "1999-04", "PrimaryCompletionDate": "2001-12", "Interventions": [ { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "stereotactic radiosurgery", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02833701", "BriefTitle": "Bevacizumab and Ascorbic Acid in Patients Treating With Recurrent High Grade Glioma", "OfficialTitle": "A Phase I Study of Bevacizumab and Intravenous Ascorbic Acid for Patients With Recurrent High Grade Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2016-03", "PrimaryCompletionDate": "2019-03", "Interventions": [ { "Name": "Ascorbic Acid", "Type": "DIETARY_SUPPLEMENT", "Description": "Given IV", "OtherNames": [ "2-(1,2-dihydroxyethyl)-4,5-dihydroxy-furan-3-one", "Asorbicap", "C Vitamin", "C-Long", "Ce-Vi-Sol", "Cecon", "Cenolate", "Cetane", "Cevalin", "L-Ascorbic Acid", "VIT C", "Vitamin C", "Vitamin-C" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given intravenously (IV)", "OtherNames": [ "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF rhuMAb", "Avastin", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Nebraska", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00387894", "BriefTitle": "Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase-2 Study of Tarceva in Patients With Recurrent EGFR Positive and Phosphatase and Tensin Homolog (PTEN) Wild Type Glioblastoma Multiforme and Gliosarcoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2007-01", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "Tarceva will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients who are not receiving EIAED (Group A) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED (Group B) will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days to 200 mg/day (Group A) or 650 mg/day (Group B) assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.", "OtherNames": [ "Tarceva" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Michael Prados", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01830101", "BriefTitle": "A Phase III Study of Re-Irradiation in Recurrent Glioblastoma", "OfficialTitle": "A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE3" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2015-05", "Interventions": [ { "Name": "TMZ plus concurrent re-irradiation", "Type": "DRUG", "Description": null, "OtherNames": [ "Temedol" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "low-dose temozolomide daily for one year", "OtherNames": [ "Temedol" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00400322", "BriefTitle": "Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection", "OfficialTitle": "A Randomized Double Blind Controlled Proof of Concept Study of the Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma With Successful Surgical Resection of at Least 90 % of the Initial Tumor and CMV Infection Demonstrated Histologically and Immunohistochemically.", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2006-08", "PrimaryCompletionDate": "2008-06", "Interventions": [ { "Name": "Valganciclovir (Valcyte)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Karolinska Institutet", "LeadSponsorClass": "OTHER", "Collaborators": [ "Karolinska University Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00112866", "BriefTitle": "Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of EMD 121974 for Recurrent Glioblastoma: A Clinical Trial With Tissue Correlates of Response", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo tumor resection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01470794", "BriefTitle": "Study of a Retroviral Replicating Vector Combined With a Prodrug to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor", "OfficialTitle": "A Phase 1 Ascending Dose Trial of Safety and Tolerability of Toca 511, a Retroviral Replicating Vector, Administered to Subjects at the Time of Resection for Recurrent High Grade Glioma & Followed by Treatment With Toca FC, Extended-Release 5-FC", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-02", "PrimaryCompletionDate": "2016-04-12", "Interventions": [ { "Name": "Toca 511 vector", "Type": "BIOLOGICAL", "Description": "All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antifungal 5-FC to the anti-cancer drug 5-FU in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after administration of Toca 511, patients will begin courses of oral Toca FC at pre-specified intervals, depending on cohort, during the approximately 30 week study.", "OtherNames": [ "Toca 511, RRV, retroviral replicating vector", "5-FC, flucytosine, 5-fluorocytosine, Toca FC" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC", "Type": "DRUG", "Description": null, "OtherNames": [ "flucytosine, 5-FC, 5-FC XR, Toca FC" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05095441", "BriefTitle": "A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Phase 1 Open-Label Study of Genetically Engineered Oncolytic HSV-1 (C5252) Expressing IL-12 and Anti-PD-1 Antibody in Patients With Recurrent or Progressive Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-03-15", "PrimaryCompletionDate": "2023-04-30", "Interventions": [ { "Name": "C5252", "Type": "BIOLOGICAL", "Description": "A single dose of C5252 will be administered up to 2mL as intratumoral injection on Day 1.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "ImmVira Pharma Co. Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT01502241", "BriefTitle": "Phase III Trial of Primary Radio- or Chemotherapy in Malignant Astrocytoma of the Elderly", "OfficialTitle": "Temozolomid (One Week on/One Week Off) Versus Strahlentherapie in Der Primärtherapie Anaplastischer Astrozytome Und Glioblastome Bei älteren Patienten: Eine Randomisierte Phase III-Studie (Methvsalem)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2010-11", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "100 mg/m2 per day on seven out of fourteen days.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy of the partial brain.", "Type": "RADIATION", "Description": "60 Gy in 30 fractions à 2 Gy.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Heidelberg University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05083754", "BriefTitle": "Carmustine Wafer in Combination With Retifanlimab and Radiation With/Without Temozolomide in Subjects With Glioblastoma", "OfficialTitle": "A Randomized, Open-label Pilot Trial to Evaluate the Safety and Efficacy of Carmustine Wafer in Combination With Retifanlimab and Standard Radiation With or Without Temozolomide in Newly-Diagnosed Adult Subjects With Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-08-31", "PrimaryCompletionDate": "2028-01", "Interventions": [ { "Name": "Retifanlimab", "Type": "DRUG", "Description": "Anti-PD-1 Therapy", "OtherNames": [ "INCMGA00012" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Anti-PD-1 Therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Standard of Care", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Incyte Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00362921", "BriefTitle": "Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Gliadel Plus 06-Benzylguanine for Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-04", "PrimaryCompletionDate": "2007-08", "Interventions": [ { "Name": "Gliadel wafers in combination with O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [ "Gliadel wafer (carmustine)" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00274833", "BriefTitle": "Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Erlotinib With Temozolomide and Concurrent Radiation Therapy Post-Operatively in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-10", "PrimaryCompletionDate": "2007-10", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "Erlotinib is available as 25 mg, 100 mg, and 150 mg tablets. It should be administered orally once daily at the prescribed dose specified in the clinical study protocol per dose escalation schema. Preferably, erlotinib should be taken in the morning with up to 200 mL of water at least 1 hour before or 2 hours after a meal.", "OtherNames": [ "Tarceva" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "TMZ is supplied in white opaque, preservative-free, two piece hard gelatin capsules of the following sizes: 100mg capsules, 20mg capsules, and 5mg capsules. TMZ will be a once a day orally administered (75 mg/m2 x BSA x 42 days)set of capsules taken at least two hours after and one hour before a meal.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Concomitant focal RT will be delivered once daily at 2 Gy per fraction, 5 d/wk, for a total of 60 Gy. (6 weeks) as mentioned in therapeutic modalities.", "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "David Peereboom", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00943007", "BriefTitle": "Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors", "OfficialTitle": "Randomized Assessment of Conventional Neuronavigation Versus Intraoperative MRI for the Neurosurgical Treatment of Glioblastomas", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2010-02", "PrimaryCompletionDate": "2013-06", "Interventions": [ { "Name": "Stealth Station", "Type": "DEVICE", "Description": "Neuronavigation based on preoperative MRI", "OtherNames": [ "cNN" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PoleStar N20", "Type": "DEVICE", "Description": "Intraoperative MRI guided surgery", "OtherNames": [ "iMRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Maastricht University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00589875", "BriefTitle": "Phase 2a Study of CAN-2409 With Standard Radiation Therapy for Malignant Glioma", "OfficialTitle": "A Phase IIa Study of AdV-tk + Valacyclovir Gene Therapy in Combination With Standard Radiation Therapy for Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-03", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "CAN-2409", "Type": "BIOLOGICAL", "Description": "Single dose of 3x10e11 vector particles of CAN-2409 delivered to the tumor bed after resection on day 0.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Valacyclovir", "Type": "DRUG", "Description": "Single course of valacyclovir at dose of 2 grams orally three times per day for 14 days starting on day 1-3", "OtherNames": [ "Valtrex" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concomitant TMZ will be administered orally once a day at a dose of 75 mg/m2 starting the next day after completing prodrug and continued for 6 weeks. Adjuvant TMZ will be administered days 1 to 5 of a 28-day cycle for 6 cycles with 150 mg/m2 administered for cycle 1, and 150 to 200 mg/m2 administered for cycles 2 to 6. Adjuvant treatment will start 1 month following completing RT.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Radiation will be administered to up-front patients as per standard of care for the patient. It will start 3-7 days after CAN-2409 injection, preferably closer to 3 days. It will consist of standard external field radiation, limited to the area of tumor and brain adjacent to tumor, fractionated at doses of 200cGy per day for approximately 6 weeks to a total of 5500-6000 cGy.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Candel Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04587830", "BriefTitle": "ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Glioblastoma Multiforme", "OfficialTitle": "Phase 1-2 Trial of ADI-PEG 20 Plus Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-09-14", "PrimaryCompletionDate": "2027-02-28", "Interventions": [ { "Name": "ADI-PEG 20", "Type": "DRUG", "Description": "Investigational Medicine", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Investigational Medicine", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Polaris Group", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05450744", "BriefTitle": "131I-TLX-101 for Treatment of Newly Diagnosed Glioblastoma (IPAX-2)", "OfficialTitle": "A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-01", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "131I-IPA", "Type": "DRUG", "Description": "131I-IPA: injection/solution administrated intravenously via infusion in ascending doses 18F-FET: injection/solution administrated intravenously", "OtherNames": [ "18F-FET" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Telix Pharmaceuticals (Innovations) Pty Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03672721", "BriefTitle": "IA Carboplatin + Radiotherapy in Relapsing GBM", "OfficialTitle": "A Phase II Study in Relapsing Glioblastoma of Intraarterial Concurrent Chemoradiation Therapy Using IA Carboplatin", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-07-10", "PrimaryCompletionDate": "2025-12-10", "Interventions": [ { "Name": "IA Carbo+ Radiation", "Type": "DRUG", "Description": "combination of intraarterial carboplatin + radiation in dose escalation", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Université de Sherbrooke", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05054400", "BriefTitle": "Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR", "OfficialTitle": "Study of Laser Interstitial Thermal Therapy (LITT) Treatment Response Assessment With Fluciclovine PET MR", "OverallStatus": "WITHDRAWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-02-05", "PrimaryCompletionDate": "2023-08-29", "Interventions": [ { "Name": "F18 Fluciclovine", "Type": "DRUG", "Description": "Given by IV", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standard of Care", "Type": "OTHER", "Description": "Standard of care", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03216499", "BriefTitle": "HIF-2 Alpha Inhibitor PT2385 in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Single-Arm, Open-Label Phase II Efficacy Study of First-in-Class HIF-2 Alpha Inhibitor, PT2385, for Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-09-14", "PrimaryCompletionDate": "2019-08-31", "Interventions": [ { "Name": "HIF-2alpha Inhibitor PT2385", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "HIF-2alpha Inhibitor PT2385, PT2385" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacogenomic Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "PHARMACOGENOMIC, Pharmacogenomic Study" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00441142", "BriefTitle": "Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors", "OfficialTitle": "Phase I/II Study of ZD6474 (Vandetanib) With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-05-25", "PrimaryCompletionDate": "2013-08-31", "Interventions": [ { "Name": "ZD6474", "Type": "DRUG", "Description": "Taken orally once a day (at 100 mg/day is the phase II dose; the MTD determined by the phase I portion of the trial) until disease gets worse or participants experience unacceptable side effects", "OtherNames": [ "Vandetanib", "Zactima" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "During the 'Induction' phase: 75/mg/m2/day temozolomide will be given orally daily for 6 weeks (42 days) during radiation therapy, beginning either the night before or on the first day of the first fraction of radiation, including weekends and holidays. This is followed by a 4-6 week break.\n\nDuring the 'Maintenance' phase: The first post-radiation temozolomide cycle will be administered at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle. If 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given. This is given for 12 cycles.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiotherapy must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy.", "OtherNames": [ "RT", "XRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Patrick Y. Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dana-Farber Cancer Institute", "Beth Israel Deaconess Medical Center", "Massachusetts General Hospital", "University of Virginia", "Memorial Sloan Kettering Cancer Center", "Henry Ford Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01067469", "BriefTitle": "Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "Randomized Phase II Trial of Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) In Adults With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-01", "PrimaryCompletionDate": "2016-10", "Interventions": [ { "Name": "Standard Dose Bevacizumab", "Type": "DRUG", "Description": "10 mg/kg by vein (IV) over 90 minutes on Days 1, 15, and 29 of 6 week cycle.", "OtherNames": [ "Avastin", "Anti-VEGF monoclonal antibody", "rhuMAb-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Low Dose Bevacizumab", "Type": "DRUG", "Description": "5 mg/kg IV over 90 minutes on Day 1 and 22 (every 3 weeks) of 6 week cycle.", "OtherNames": [ "Avastin", "Anti-VEGF monoclonal antibody", "rhuMAb-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Starting dose of 75 mg/m2 administered orally at sleep time on Day 3 of every 6 week cycle.", "OtherNames": [ "CeeNU", "CCNU" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02669173", "BriefTitle": "Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma", "OfficialTitle": "Targeting Myeloid Derived Suppressor Cells in Recurrent Glioblastoma: Phase 0/1 Trial of Low Dose Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2016-10-11", "PrimaryCompletionDate": "2019-03-25", "Interventions": [ { "Name": "Capecitabine", "Type": "DRUG", "Description": "Drug given orally. Dose to be determined by phase 1 dose escalation, cycle length 28 days. Treatment until progression", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Drug given by IV, 10 mg/kg days 1, 15 every 28 days, until progression.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02104882", "BriefTitle": "INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study", "OfficialTitle": "INTRAGO-Intraoperative Radiotherapy for Glioblastoma - a Phase I/II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-03", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "Intraoperative Radiotherapy (Applicator Surface Dose: 20-40 Gy)", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Universitätsmedizin Mannheim", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02885324", "BriefTitle": "Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children", "OfficialTitle": "Pilot Study of Cabozantinib for Recurrent or Progressive Central Nervous System Tumors in Children", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2017-05-18", "PrimaryCompletionDate": "2020-08-25", "Interventions": [ { "Name": "Cabozantinib", "Type": "DRUG", "Description": "Subjects will receive Cabozantinib", "OtherNames": [ "XL 184", "Cabometyx" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Indiana University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04319276", "BriefTitle": "Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma", "OfficialTitle": "A Phase 1 Clinical Trial of Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-11-11", "PrimaryCompletionDate": "2025-02-13", "Interventions": [ { "Name": "Gallium maltolate (500 mg)", "Type": "DRUG", "Description": "This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.", "OtherNames": [ "Chemical Abstracts Service (CAS) 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gallium maltolate (1,000 mg)", "Type": "DRUG", "Description": "This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.", "OtherNames": [ "CAS 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gallium maltolate (1,500 mg)", "Type": "DRUG", "Description": "This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.", "OtherNames": [ "CAS 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gallium maltolate (2,000 mg)", "Type": "DRUG", "Description": "This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.", "OtherNames": [ "CAS 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gallium maltolate (2,500 mg)", "Type": "DRUG", "Description": "This is a 3+3 design. The doses are as follows: level -1: 500 mg every other day; level 0: (starting dose) 500 mg daily; level 1: 1,000 mg daily; level 2: 1,500 mg daily; level 3: 2,000 mg daily; level 4: 2,500 mg daily.", "OtherNames": [ "CAS 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Gallium maltolate (recommended phase 2 dose)", "Type": "DRUG", "Description": "The maximum-tolerated dose (recommended phase 2 dose).", "OtherNames": [ "CAS 108560-70-9" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical College of Wisconsin", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00613223", "BriefTitle": "Ph I Dose Escalation Trial of Vandetanib in Combo w Etoposide for Malignant Gliomas", "OfficialTitle": "Phase I Dose Escalation of Vandetanib (Zactima, ZD6474) in Combination With Etoposide for Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-02", "PrimaryCompletionDate": "2010-10", "Interventions": [ { "Name": "Vandetanib and Etoposide", "Type": "DRUG", "Description": "Vandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 100 mg/day for stratum 1 \\& 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at a flat dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle.", "OtherNames": [ "Vandetanib - Zactima (ZD 6474)", "Etoposide - VP-16, Etopophos, Toposar, VePesid" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01756352", "BriefTitle": "FET-PET for Evaluation of Response of Recurrent GBM to Avastin", "OfficialTitle": "Assessment of the Utility of the Radiotracer \"FET\"in PET Imaging of Recurrent Glioblastoma Multiforme (GBM): Monitoring Early Response to Antiangiogenic Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-02", "PrimaryCompletionDate": "2015-09-13", "Interventions": [ { "Name": "18F-FET", "Type": "DRUG", "Description": "Radiotracer, surrogate marker for protein synthesis", "OtherNames": [ "18F-Fluoroethyltyrosine" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Marcelo F. Di Carli, MD, FACC", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00268385", "BriefTitle": "Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas", "OfficialTitle": "A Phase I Study of Vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in Combination With Temozolomide in Patients With Malignant Gliomas", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2005-12-16", "PrimaryCompletionDate": "2018-10-18", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Vorinostat", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "L-001079038", "MSK-390", "SAHA", "Suberanilohydroxamic Acid", "Suberoylanilide Hydroxamic Acid", "Zolinza" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01989884", "BriefTitle": "An Efficacy Study Of Ortataxel In Recurrent Glioblastoma", "OfficialTitle": "Multicenter, Single Arm, Open-Label Phase II Trial On The Efficacy Of Ortataxel In Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-11", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "Ortataxel", "Type": "DRUG", "Description": "75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.", "OtherNames": [ "IDN5109" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mario Negri Institute for Pharmacological Research", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00387933", "BriefTitle": "Imatinib Mesylate, Vatalanib, and Hydroxyurea in Treating Patients With Recurrent or Relapsed Malignant Glioma", "OfficialTitle": "Phase I Dose Escalation of Gleevec in Combination With PTK787/ZK 222584 (PTK/ZK) Plus Hydroxyurea", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-07", "PrimaryCompletionDate": "2009-01", "Interventions": [ { "Name": "hydroxyurea", "Type": "DRUG", "Description": null, "OtherNames": [ "HU", "hydrea" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [ "Gleevec" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "vatalanib", "Type": "DRUG", "Description": null, "OtherNames": [ "PTK787" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00171938", "BriefTitle": "Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)", "OfficialTitle": "Open-label Trial of Imatinib Mesylate in Patients With Unresectable Recurrent Glioblastoma Multiforme Expressing PDGFR (Platelet Derived Growth Factor Receptors)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2004-04", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01648348", "BriefTitle": "Bevacizumab With or Without Anti-Endoglin Monoclonal Antibody TRC105 in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naive Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-11", "PrimaryCompletionDate": "2016-05-11", "Interventions": [ { "Name": "Anti-Endoglin Chimeric Monoclonal Antibody TRC105", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "TRC105" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF rhuMAb", "Avastin", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar FKB238", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02550249", "BriefTitle": "Neoadjuvant Nivolumab in Glioblastoma", "OfficialTitle": "Phase II Study of Neoadjuvant Nivolumab in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-06", "PrimaryCompletionDate": "2017-03", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Intravenous administration of nivolumab", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Clinica Universidad de Navarra, Universidad de Navarra", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT00369785", "BriefTitle": "Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors", "OfficialTitle": "Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2008-02", "PrimaryCompletionDate": "2012-07-01", "Interventions": [ { "Name": "donepezil hydrochloride", "Type": "DRUG", "Description": "Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily", "OtherNames": [ "Donepezil" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004937", "BriefTitle": "Acridine Carboxamide in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Open Label Phase II Study on XR5000 Administered as a 5 Day Infusion in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-10", "PrimaryCompletionDate": "2000-05", "Interventions": [ { "Name": "acridine carboxamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06496971", "BriefTitle": "A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients", "OfficialTitle": "A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-11-08", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "An anti-angiogenic agent to block tumor growth", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Microbubble", "Type": "DRUG", "Description": "Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble", "OtherNames": [ "SonoVue" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Low-Intensity Focused Ultrasound", "Type": "DEVICE", "Description": "Open the Blood-Brain Barrier (BBB) using focused ultrasound and microbubble", "OtherNames": [ "NaviFUS System" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "NaviFUS Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00720564", "BriefTitle": "Radiation Therapy, Arsenic Trioxide, and Temozolomide in Treating Patients With Newly Diagnosed High-Grade Glioma", "OfficialTitle": "A Phase I Study of the Combination of Radiation Therapy (RT), Arsenic Trioxide (ATO) and Temozolomide (TMZ) in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-04", "PrimaryCompletionDate": "2009-02", "Interventions": [ { "Name": "arsenic trioxide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "intensity-modulated radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05638451", "BriefTitle": "Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients", "OfficialTitle": "Phase 2 Study to Evaluate the Efficacy and Safety of Sintilimab in Combination With Bevacizumab and Temozolomide in Recurrent Glioblastoma (GBM) Patients", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2023-05-01", "PrimaryCompletionDate": "2024-12-30", "Interventions": [ { "Name": "Sintilimab plus Bevacizumab and Temozolomide", "Type": "DRUG", "Description": "200mg Sintilimab plus 10mg/kg Bevacizumab very 3 weeks 200 mg/m2/day Temozolomide on days 1-5 out of a 28 days schedule", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Zhujiang Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06095375", "BriefTitle": "Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients", "OfficialTitle": "Regorafenib in Combination With Temozolomide With or Without Radiotherapy in Patients With Newly Diagnosed MGMT-Methylated, IDH Wild-type Glioblastoma. A Phase I Dose-finding Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-07-04", "PrimaryCompletionDate": "2024-10-09", "Interventions": [ { "Name": "Regorafenib", "Type": "DRUG", "Description": "Cohort A (Adjuvant/Maintenance Phase). The Adjuvant (Maintenance) Therapy dose escalation will explore three dose levels of regorafenib (e.g., 80 mg, 120 mg and 160 mg; level-1: regorafenib 40 mg will be evaluated in case of DLT during regorafenib 80 mg) administered in combination with adjuvant TMZ to evaluate the initial toxicity of regorafenib and TMZ Cohort B (Concomitant Phase) Therapy dose escalation will explore three dose levels of regorafenib (e.g., 80 mg, 120 mg and 160 mg; level -1: regorafenib 40 mg will be evaluated in case of DLT during regorafenib 80 mg) administered in combination with TMZ and RT.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Following a \"3+3\" design, in cohort A three patients will be administered temozolomide 150-200 mg/m2 for 5 consecutive days every 28 days until 6-12 cycles and regorafenib daily for 21 days, with a 1-week washout period at dose of 80 mg (level 1), 120 mg (level 2), or 160 mg (level 3) (regorafenib 40 mg- level -1). As a general rule, one cycle will last 28 days (day 1-28); however, in the event of treatment prolongation, the cycle period will be extended.\n\nIn cohort B,During concomitant therapy phase: temozolomide 75 mg/m2/die for 42 (max 49 days) consecutive days (concomitant with radiation therapy).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Istituto Oncologico Veneto IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bayer S.p.A" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01473901", "BriefTitle": "A Phase I Dose Escalation Study of BKM120 With Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I, Two-stage, Multi-center, Open Label, Dose-escalation Study of BKM120 in Combination With Adjuvant Temozolomide and With Concomitant Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-12-30", "PrimaryCompletionDate": "2017-05-17", "Interventions": [ { "Name": "BKM120 + temozolomide", "Type": "DRUG", "Description": "The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "BKM120 +temozolomide with/without radiotherapy", "Type": "DRUG", "Description": "The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a continuous once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01351519", "BriefTitle": "A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors", "OfficialTitle": "A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2015-01", "Interventions": [ { "Name": "Aminolevulinic Acid", "Type": "DRUG", "Description": "Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.", "OtherNames": [ "ALA", "5-Aminolevulinic Acid", "Levulan" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "MultiCare Health System Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06632236", "BriefTitle": "5G-EMERALD: Amivantamab in Malignant Brain Tumours", "OfficialTitle": "5G-EMERALD: A Phase 1 Trial of Amivantamab in High Grade Malignant Brain Tumours Within the 5G Platform", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-10-09", "PrimaryCompletionDate": "2026-03-05", "Interventions": [ { "Name": "Amivantamab", "Type": "DRUG", "Description": "Amivantamab will be supplied in single-use 350 mg injectable solution, provided as a 7 ml per glass vial (50mg/ml), intended for IV infusion.", "OtherNames": [ "JNJ-61186372" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institute of Cancer Research, United Kingdom", "LeadSponsorClass": "OTHER", "Collaborators": [ "Royal Marsden NHS Foundation Trust", "Cambridge University Hospitals NHS Foundation Trust", "Janssen Pharmaceutica N.V., Belgium", "Cancer Research UK", "Minderoo Foundation", "University of Cambridge" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06058988", "BriefTitle": "Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer", "OfficialTitle": "Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-09-22", "PrimaryCompletionDate": "2027-09-22", "Interventions": [ { "Name": "Trastuzumab deruxtecan", "Type": "DRUG", "Description": "All participants will receive T-DXd prior to indicated brain tumor resection/biopsy", "OtherNames": [ "T-DXd" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00613054", "BriefTitle": "Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma", "OfficialTitle": "Phase I Study of Zactima (ZD6474) Plus Imatinib Mesylate and Hydroxyurea for Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-11", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "Zactima, Gleevec, Hydroxyurea", "Type": "DRUG", "Description": "Pts will start treatment on day 1 of cycle 1 w Zactima, imatinib mesylate \\& hydroxyurea. All 3 agents administered in continuous daily, oral manner. Imatinib mesylate dose 400 mg/day for pts not on EIAEDs \\& 1000 mg/day for pts on EIAEDs based on previous studies demonstrating that pts on EIAEDs require significantly higher doses of imatinib mesylate \\& that such doses are safe \\& well tolerated. Dose of hydroxyurea 500 mg twice day. Dose level of Zactima will be increased in successive cohorts of pts as described below.\n\nCohorts of 3-6 pts will accrue at each dose level until MTD is defined. Each cohort will consist of a mini of 3 newly enrolled pts. Intra-patient dose escalation is not permitted. Cohorts may be expanded at any dose level for further elaboration of safety \\& pharmacokinetic parameters as required.\n\nTreatment cycle is defined as daily administration of Zactima + imatinib mesylate \\& hydroxyurea for 28 days for purpose of scheduling evaluations.", "OtherNames": [ "Zactima-ZD6474-Vandetanib", "Gleevec-Imatinib mesylate", "Hydroxyurea-Droxia-Hydrea-Hydroxycarbamide" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals", "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00005637", "BriefTitle": "Combination Chemotherapy Following Radiation Therapy in Treating Patients With Malignant Glioma", "OfficialTitle": "A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1999-12", "PrimaryCompletionDate": "2003-06", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01115036", "BriefTitle": "A Panobinostat Presurgery", "OfficialTitle": "Phase II Study of Panobinostat (LBH589) for Recurrent Glioblastoma (GBM) Undergoing Planned Surgical Resection", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2011-04", "Interventions": [ { "Name": "panobinostat", "Type": "DRUG", "Description": "Oral panobinostat will be administered at 20mg by mouth 3 times a week one week prior to surgical resection. Within 2-6 weeks of resection, patients will resume panobinostat at 20mg 3 times per week. A cycle will be 28 days.", "OtherNames": [ "LBH589" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01403311", "BriefTitle": "A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain", "OfficialTitle": "A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "5-Aminolevuline Acid", "Type": "DRUG", "Description": "5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Legacy Health System", "LeadSponsorClass": "OTHER", "Collaborators": [ "DUSA Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01810744", "BriefTitle": "Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma", "OfficialTitle": "Study of Microcirculatory Effects of Bevacizumab in Patients Treated for Metastatic Colon Cancer or Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2015-05", "Interventions": [ { "Name": "capillaroscopy", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "blood pressure measurement", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Centre Georges Francois Leclerc", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00436436", "BriefTitle": "O(6)-Benzylguanine and Temozolomide in Treating Patients With Glioblastoma Multiforme That Did Not Respond to Previous Temozolomide and Radiation Therapy", "OfficialTitle": "A Phase 2 Study of O-Benzylguanine (O-BG) and Temozolomide in Patients With Glioblastoma Progressing at Least 3 Months After Completion of Primary Treatment With Radiation Therapy and Temozolomide", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2006-11-13", "PrimaryCompletionDate": "2010-03-15", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [ "06-BG" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03926507", "BriefTitle": "F18 Fluciclovine PET/CT in Assessing Tumor Volume and Radiation Therapy Response in Patients With Glioblastoma Undergoing Surgery", "OfficialTitle": "Study of F18 Fluciclovine PET CT for Assessment of Glioblastoma Tumor Volume and Radiation Response", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-04-30", "PrimaryCompletionDate": "2023-09-18", "Interventions": [ { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT scan", "OtherNames": [ "CAT", "CAT Scan", "Computerized Axial Tomography", "computerized tomography", "CT", "CT SCAN", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Fluciclovine F18", "Type": "OTHER", "Description": "Given IV", "OtherNames": [ "(18F)Fluciclovine", "(18F)GE-148", "18F-Fluciclovine", "[18F]FACBC", "Anti-(18f)FABC", "Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid", "Anti-[18F] FACBC", "Axumin", "Fluciclovine (18F)", "FLUCICLOVINE F-18", "GE-148 (18F)", "GE-148 F-18" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT scan", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET SCAN", "positron emission tomography scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00002971", "BriefTitle": "O(6)-Benzylguanine in Treating Patients With Malignant Glioma", "OfficialTitle": "A Phase I Trial of Pre-Surgical O6-Benzylguanine in the Treatment of Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1997-06-19", "PrimaryCompletionDate": "2003-02-20", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03971734", "BriefTitle": "Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas", "OfficialTitle": "Determining the Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2019-12-06", "PrimaryCompletionDate": "2022-04-30", "Interventions": [ { "Name": "Regadenoson 0.05mg", "Type": "DRUG", "Description": "Regadensoson 0.05mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 0.1mg", "Type": "DRUG", "Description": "Regadensoson 0.1mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 0.2mg", "Type": "DRUG", "Description": "Regadensoson 0.2mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 0.4mg", "Type": "DRUG", "Description": "Regadensoson 0.4mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 0.7mg", "Type": "DRUG", "Description": "Regadensoson 0.7mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 1.0mg", "Type": "DRUG", "Description": "Regadensoson 1.0mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Regadensoson 1.4mg", "Type": "DRUG", "Description": "Regadensoson 1.4mg administered prior to MRI", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01172964", "BriefTitle": "A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas", "OfficialTitle": "A Pilot Feasibility Study of Oral 5-Fluorocytosine and Genetically-Modified Neural Stem Cells Expressing E.Coli Cytosine Deaminase for Treatment of Recurrent High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2015-02-11", "Interventions": [ { "Name": "flucytosine", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "5-FC", "5-fluorocytosine", "Alcobon", "Ancobon", "Ancotil", "Ro 2-9915" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "polymerase chain reaction", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "PCR" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "immunohistochemistry" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "gene therapy", "Type": "BIOLOGICAL", "Description": "Injected at the time of the surgery to resect the tumor", "OtherNames": [ "therapy, gene" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "3-Tesla magnetic resonance imaging", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "3-Tesla MRI", "3T MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Surgery to resect the tumor", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "E. coli CD-expressing genetically modified neural stem cells", "Type": "BIOLOGICAL", "Description": "Injected at the time of the surgery to resect the tumor", "OtherNames": [ "HB1.F3.CD neural stem cells" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02772094", "BriefTitle": "Dendritic Cell-Based Tumor Vaccine Adjuvant Immunotherapy of Human Glioblastoma Multiforme (WHO Grade IV Gliomas)", "OfficialTitle": "Autologous Dendritic Cell-Based Adjuvant Immunotherapy of Malignant Gliomas (WHO Grade IV Glioblastoma Multiforme) - Phase II Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2005-05", "PrimaryCompletionDate": "2014-12", "Interventions": [ { "Name": "Single arm, open-label", "Type": "BIOLOGICAL", "Description": "Biological: ADCTA-G. Biological: autologous DC loaded with irradiated autologous tumor cells. Biological: dendritic cell \"vaccine\". Drug: 180mg/m2•per day temozolomide prior and concomitant with radiotherapy. Radiotherapy: Local ionizing radiation 200 centigray(cGy)/day, 5 successive days per week for 6 weeks, total dose of 6000 cGy.\n\nDrug: Adjuvant chemotherapy-temozolomide (TMZ) monthly cycle, 200mg/m2•per day continued for 5 days in the beginning of every month, 6 cycles of TMZ.", "OtherNames": [ "ADCTA-G" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "China Medical University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Den-Mei Brain Tumor Education Foundation, Taichung, Taiwan", "Ministry of Health and Welfare, Taiwan" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00002545", "BriefTitle": "Radiation Therapy Plus Chemotherapy in Treating Patients With Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A PHASE III TRIAL COMPARING THE USE OF RADIOSURGERY FOLLOWED BY CONVENTIONAL RADIOTHERAPY WITH BCNU TO CONVENTIONAL RADIOTHERAPY WITH BCNU FOR SUPRATENTORIAL GLIOBLASTOMA MULTIFORME", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "1994-02", "PrimaryCompletionDate": "2004-12", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "low-LET photon therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06687681", "BriefTitle": "Injection of Active Allogeneic Natural Killer Cells in Patients With Gliomas", "OfficialTitle": "Efficacy of the Intrathecal Injection of Active Allogeneic Natural Killer Cells in Patients With High-grade Gliomas; A Multi-center Phase II Clinical Trial", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-11-25", "PrimaryCompletionDate": "2025-11-25", "Interventions": [ { "Name": "NK cell therapy", "Type": "BIOLOGICAL", "Description": "Active NK cell injection through lumbar puncture in patient with Astrocytoma IDH-mutant, Oligodendroglioma IDHmutant, Glioblastoma IDH-wild type, Diffuse midline glioma, Diffuse hemispheric glioma, Diffuse pediatrictype high-grade glioma IDH-wild type", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Marzieh Ebrahimi", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT00002752", "BriefTitle": "Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Brain Cancers", "OfficialTitle": "PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1993-02", "PrimaryCompletionDate": "2003-01", "Interventions": [ { "Name": "iodine I 131 monoclonal antibody 81C6", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04856852", "BriefTitle": "Iodine-125 Brachytherapy Together With Chemotherapy in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Iodine-125 Brachytherapy Together With Chemotherapy Compared With Surgical Resection Followed by Concomitant Radiochemotherapy in Patients With Newly Diagnosed Glioblastoma，a Randomized, Open-label, Multi-center Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-06-28", "PrimaryCompletionDate": "2022-08-01", "Interventions": [ { "Name": "Iodine-125+Chemotherapy", "Type": "OTHER", "Description": "Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.", "OtherNames": [ "Iodine-125+Temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgical resection+Radiochemotherapy", "Type": "OTHER", "Description": "Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection.\n\nRadiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.", "OtherNames": [ "Surgical resection+Radiotherapy+Temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "The Affiliated Hospital of Qingdao University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03573986", "BriefTitle": "Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment", "OfficialTitle": "Pilot Study of 18F-FMISO PET/CT and MRI Imaging to Explore Tissue Hypoxia and Arteriovenous Shunting in Subjects With Recurrent Glioblastoma Before and After Bevacizumab Treatment", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-04-18", "PrimaryCompletionDate": "2020-01-14", "Interventions": [ { "Name": "[18F]fluoromisonidazole", "Type": "BIOLOGICAL", "Description": "positron emitting radiopharmaceutical that has been studied in vivo in humans for measurement of regional hypoxia in a number of tumor types with positron emission tomography (PET/CT)", "OtherNames": [ "18F-FMISO" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab (Avastin, Genentech/Roche) is a humanized monoclonal antibody that binds to VEGF preventing its interaction with VEGFRs resulting in suppression of VEGF signaling.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "positron emission tomography (PET/CT).", "Type": "RADIATION", "Description": "PET-CT Scan 1.) before start of Bevacizumab up to approximately 4 weeks and 2.) within 12-22 days of start of Bevacizumab", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03231501", "BriefTitle": "HMPL-813 in Treating Patients With Glioblastoma", "OfficialTitle": "A Phase Ib, Multi-center, Open-label Study of Epitinib Succinate (HMPL-813) in Treating Patients With Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2018-01-26", "PrimaryCompletionDate": "2020-06-30", "Interventions": [ { "Name": "epitinib succinate", "Type": "DRUG", "Description": "This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Hutchison Medipharma Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05109728", "BriefTitle": "A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.", "OfficialTitle": "A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Radiotherapy With or Without Temozolomide and in Recurrent Glioblastoma as Single Agent", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-05-10", "PrimaryCompletionDate": "2026-06-05", "Interventions": [ { "Name": "[177Lu]Lu-DOTA-TATE", "Type": "DRUG", "Description": "Group 1: \\[177Lu\\]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 4 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed.\n\nGroup 3: \\[177Lu\\]Lu-DOTA-TATE, dose level 0 (150mCi) administered every 3 weeks. Three provisional dose levels (Dose level +2: 250 mCi; Dose level +1: 200 mCi; Dose level -1: 100 mCi) will be assessed.", "OtherNames": [ "Lutathera", "Lutetium (177Lu)oxodotreotide", "Lutetium Lu 177dotatate" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "[68Ga]Ga-DOTA-TATE", "Type": "DRUG", "Description": "2 MBq/kg of body weight (0.054 mCi/kg), with a minimum dose of 100 MBq (2.7 mCi) and maximum dose of 200 MBq (5.4 mCi)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "OTHER", "Description": "Concomitant Phase: Temozolomide 75mg/m2/d p.o until last day of EBRT.\n\nMaintenance Phase: Temozolomide p.o 150 mg/m2/d during cycle 1 then 200 mg/m2/d for the following cycles if tolerated well in Cycle 1. 6 cycles total (1 cycle = every 28 days)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "OTHER", "Description": "2 Gy/day, 5 days per week followed by 2 days of rest, for 6 consecutive weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00004212", "BriefTitle": "DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas", "OfficialTitle": "A Phase I Dose Escalation Study of Intravenous DX-8951f Administered Daily for Five Days Every Three Weeks to Pediatric Patients With Advanced Solid Tumors and Lymphomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1999-09", "PrimaryCompletionDate": "2004-04", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "exatecan mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Daiichi Sankyo", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003141", "BriefTitle": "Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors", "OfficialTitle": "A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-03", "PrimaryCompletionDate": "2007-12", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "GRANULOCYTE COLONY-STIMULATING FACTOR", "r-metHuG-CSF", "G-CSF" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Paraplatin", "CBDCA", "NSC #241240" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cisplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Cis-diamminedichloroplatinum II", "Platinol-AQ", "NSC #119875" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CTX", "Cytoxan", "NSC #026271" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "VP-16", "VePesid", "Etopophos", "NSC #141540" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Tespa", "Tspa", "NSC #639" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "VCR", "Oncovin", "NSC #067574" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT07141732", "BriefTitle": "Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System for Intraoperative Balloon Electronic Brachytherapy", "OfficialTitle": "Pilot Prospective Single-center Non-comparative Study: Combined Treatment of Patients With Newly Diagnosed Glioblastoma Using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System for Intraoperative Balloon Electronic Brachytherapy", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-09-01", "PrimaryCompletionDate": "2026-03-01", "Interventions": [ { "Name": "Resection of newly diagnosed glioblastoma combined with intraoperative balloon electronic brachytherapy using the Xoft® Axxent® Electronic Brachytherapy (eBx®) System", "Type": "BIOLOGICAL", "Description": "The Elekta Xoft® Axxent® Electronic Brachytherapy (eBx®) System is a device that delivers high-dose-rate radiation. It is designed for use with Axxent applicators to treat neoplastic tumors inside or on the body surface where radiation therapy is indicated. The Axxent System and its applicators were cleared by the FDA under 510(k) submissions K050843, K072683, K090914, and K122951. The Russian Federation medical device registration certificate (No. RZN 2015/2593) was obtained on April 17, 2015.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Joint Stock Company European Medical Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01100177", "BriefTitle": "Study of Sunitinib Before and During Radiotherapy in Newly Diagnosed Biopsy-only Glioblastoma Patients", "OfficialTitle": "An Open Label Non- Randomized Multicentric Phase II Study of Sunitinib Before and During Radiotherapy in Newly Diagnosed Biopsy-only Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "Sunitinib", "Type": "DRUG", "Description": "Sunitinib 37.5mg/m2/d", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Radiation therapy (60Gy) 2 Gy per day during 30 days", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT06869577", "BriefTitle": "A Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma", "OfficialTitle": "Project SUGRI - a Supportive Group Intervention for Caregivers to Patients Diagnosed With a Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-05-01", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Project SUGRI: A supportive group intervention for caregivers to patients with a glioblastoma", "Type": "OTHER", "Description": "A 12-week supportive group intervention targeted caregivers to patients with glioblastoma.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rigshospitalet, Denmark", "LeadSponsorClass": "OTHER", "Collaborators": [ "Danish Cancer Society", "The Novo Nordic Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03225300", "BriefTitle": "Simultaneous Integrated Boost in Malignant Glioma Patients Treated With Chemoradiation", "OfficialTitle": "Evaluation the Prognostic Significance of High Radiation Dose in Malignant Glioma Patients Treated With Chemoradiation", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2005-01-01", "PrimaryCompletionDate": "2017-12-31", "Interventions": [ { "Name": "Simultaneous integrated boost", "Type": "RADIATION", "Description": "Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Taichung Veterans General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00053963", "BriefTitle": "FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia", "OfficialTitle": "A PHASE I STUDY OF DEPSIPEPTIDE (NSC#630176, IND# 51810) IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS AND LEUKEMIAS", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-09", "PrimaryCompletionDate": "2006-02", "Interventions": [ { "Name": "romidepsin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "FK228", "FR901228", "Istodax" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03144167", "BriefTitle": "Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy", "OfficialTitle": "Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2019-06-18", "PrimaryCompletionDate": "2027-01-20", "Interventions": [ { "Name": "Analysis of spectroscopic biomarkers of proliferation for six-month survival", "Type": "OTHER", "Description": "Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire, Amiens", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00516607", "BriefTitle": "Enzastaurin and Temozolomide in Treating Patients With Primary Gliomas", "OfficialTitle": "Phase I Study of Enzastaurin and Temozolomide in Patients With Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2007-07", "PrimaryCompletionDate": "2008-11", "Interventions": [ { "Name": "enzastaurin hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01331616", "BriefTitle": "Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab", "OfficialTitle": "A Prospective Single Institution Study of Optic Neuropathy in 10 Patients With Glioblastoma Receiving Bevacizumab", "OverallStatus": "WITHDRAWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2011-03", "PrimaryCompletionDate": "2012-07", "Interventions": [ { "Name": "Bevacizumab (Avastin)", "Type": "DRUG", "Description": "Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "West Penn Allegheny Health System", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06645808", "BriefTitle": "PET-imaging of Two Vartumabs in Patients With Solid Tumors", "OfficialTitle": "The Safety, Tolerability and Biodistribution of a Single Intravenous Administration of Two Zirconium-89 Labelled Vartumabs (F8scFV or C9scFv) in Patients With Solid Tumors - a Phase 0, Open Label, PET/CT Molecular Imaging Basket Trial", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2024-12-10", "PrimaryCompletionDate": "2026-08", "Interventions": [ { "Name": "89Zr-DFO-N-Suc-F8scFv", "Type": "BIOLOGICAL", "Description": "89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "89Zr-DFO-N-Suc-C9scFv", "Type": "BIOLOGICAL", "Description": "89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET/CT scan", "Type": "RADIATION", "Description": "IMP administration will be followed by PET/CT scans on day 1, 2 and 4.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Var2 Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "TRACER Europe BV" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03154190", "BriefTitle": "Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer", "OfficialTitle": "St. Judes-Stanford Comprehensive Support Initiative", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-08-08", "PrimaryCompletionDate": "2021-11-30", "Interventions": [ { "Name": "Best Practice", "Type": "OTHER", "Description": "Receive usual care", "OtherNames": [ "standard of care", "standard therapy" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Supportive Care", "Type": "PROCEDURE", "Description": "Undergo health care coach support", "OtherNames": [ "Supportive Therapy", "Symptom Management", "Therapy, Supportive" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Survey Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03493932", "BriefTitle": "Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade", "OfficialTitle": "Cytokine Microdialysis For Real Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-09-24", "PrimaryCompletionDate": "2023-04-21", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "BRAF", "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "BMS-986016", "Type": "DRUG", "Description": "Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "National Institute of Neurological Disorders and Stroke (NINDS)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "BRAF", "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT05502991", "BriefTitle": "Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNA-level-relapse and Clinical-relapse Glioblastoma", "OfficialTitle": "Phase 2 Study to Evaluate the Clinical Efficacy and Safety of Sintilimab Plus Low-dose Bevacizumab in Patients With Glioblastoma of Different Relapse Stages", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-12-11", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Tislelizumab plus Bevacizumab", "Type": "DRUG", "Description": "200mg sintilimab plus 3mg/kg bevacizumab every 3 weeks", "OtherNames": [ "TYVYT®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Henan Provincial People's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT05256290", "BriefTitle": "Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations", "OfficialTitle": "A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-03-31", "PrimaryCompletionDate": "2025-11-03", "Interventions": [ { "Name": "silevertinib (BDTX-1535) monotherapy", "Type": "DRUG", "Description": "Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Black Diamond Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02394626", "BriefTitle": "Surgery for Recurrent Glioblastoma", "OfficialTitle": "RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2015-05-01", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Surgery followed by adjuvant second-line therapy", "Type": "PROCEDURE", "Description": "Surgery:\n\nSurgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. However, some form of intra-operative resection control (iMRI or intra-operative fluorescence) and function control (electrophysiology) should be available to the surgeon and used when warranted.\n\nAdjuvant second-line therapy:\n\nPatients will be seen after surgery by the treating neurooncologist. Modalities of adjuvant second-line therapy are individually defined according to local guidelines and are not stipulated by study protocol.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Second-line therapy alone", "Type": "PROCEDURE", "Description": "Patients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Insel Gruppe AG, University Hospital Bern", "LeadSponsorClass": "OTHER", "Collaborators": [ "European Organisation for Research and Treatment of Cancer - EORTC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06617208", "BriefTitle": "Prognostic IntraOperative Biomarkers ideNtification in Tumor rElatEd suRgery", "OfficialTitle": "Prognostic IntraOperative Biomarkers ideNtification in Tumor rElatEd suRgery (PIONEER Study)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-12-01", "PrimaryCompletionDate": "2029-06-01", "Interventions": [ { "Name": "Neuropixel probe recording", "Type": "DEVICE", "Description": "Neuropixel recordings captures neuronal activity at the single-neuron level across the layers of the cortex.", "OtherNames": [ "laminar electrophysiology", "cortical depth electrophysiology" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Erasmus Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01291420", "BriefTitle": "Dendritic Cell Vaccination for Patients with Solid Tumors", "OfficialTitle": "Therapeutic Efficacy of Wilms' Tumor Gene (WT1) MRNA-electroporated Autologous Dendritic Cell Vaccination in Patients with Solid Tumors: a Phase I/feasibility Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-05-03", "PrimaryCompletionDate": "2016-04-25", "Interventions": [ { "Name": "autologous dendritic cell vaccination", "Type": "BIOLOGICAL", "Description": "4 biweekly intradermal DC injections of 10\\*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital, Antwerp", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006025", "BriefTitle": "Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2001-01-05", "PrimaryCompletionDate": "2005-01-10", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05183204", "BriefTitle": "Paxalisib With a High Fat, Low Carb Diet and Metformin for Glioblastoma", "OfficialTitle": "A Phase 2 Trial of Paxalisib Combined With a Ketogenic Diet and Metformin for Newly Diagnosed and Recurrent Glioblastoma", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE2" ], "StartDate": "2022-02-14", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "Paxalisib", "Type": "DRUG", "Description": "Patients will receive paxalisib starting at a dose of 45 mg/day. If well tolerated after 28 days, the dose of paxalisib will be increased to 60 mg/day.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Metformin", "Type": "DRUG", "Description": "Patients will receive metformin on Cycle 1, Day 1 at a starting dose of 850 mg QD, and if tolerated, will be increased to 850 mg BID on Cycle 2, Day 1 (1700 mg/day). If that dose is tolerated, metformin will be increased to 850 mg TID (2550 mg/day) beginning on Cycle 3, Day 1.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Ketogenic Diet", "Type": "OTHER", "Description": "The ketogenic diet is high-fat, low carbohydrate diet. Ketogenic diet will be maintained on a continuous basis starting on Cycle 1, Day 1 and continuing throughout the trial.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Weill Medical College of Cornell University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Kazia Therapeutics Limited" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00045968", "BriefTitle": "Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer", "OfficialTitle": "A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme (GBM)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2006-12", "PrimaryCompletionDate": "2022-11", "Interventions": [ { "Name": "Dendritic cell immunotherapy", "Type": "DRUG", "Description": "Two intradermal (i.d.) injections of DCVax-L(treatment cohort) or autologous PBMC (placebo cohort) per treatment. Treatments will be given at days 0, 10, 20, and at weeks 8, 16, 32, 48, 72, 96 and 120.", "OtherNames": [ "DCVax-L", "DCVax", "DCVax-Brain" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwest Biotherapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03430791", "BriefTitle": "Trial of Combination Tumor Treating Fields (TTF; Optune), Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma", "OfficialTitle": "A Phase I/II Trial of Combination Tumor Treating Fields, Nivolumab Plus/Minus Ipilimumab for Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2018-12-05", "PrimaryCompletionDate": "2020-05-29", "Interventions": [ { "Name": "Nivolumab 240 mg IV", "Type": "DRUG", "Description": "Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.", "OtherNames": [ "Nivolumab Monotherapy" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab 3 mg/kg", "Type": "DRUG", "Description": "Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.", "OtherNames": [ "Nivolumab+Ipilimumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "Ipilimumab 1 mg/kg", "Type": "DRUG", "Description": "Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.", "OtherNames": [ "Nivolumab+Ipilimumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "Name": "NovoTTF200A (Optune)", "Type": "DEVICE", "Description": "A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Baptist Health South Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "PD-1" ], "classes": [] } }, { "NCTId": "NCT02394665", "BriefTitle": "Dose Escalated MRSI Guided Radiation Therapy in Glioblastoma", "OfficialTitle": "Phase II Study of Dose Escalated, Targeted Radiation Therapy Using 3D Magnetic Resonance Spectroscopy Imaging (MRSI) in Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-03", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "Intensity Modulated Radiation Therapy", "Type": "RADIATION", "Description": "IMRT treatment will consist of 60 Gy in 30 fractions to PTV 60", "OtherNames": [ "IMRT", "Fractionated RT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days:\n\n* Concurrent during Radiation Therapy: 75 mg/m\\^2 orally for 6 weeks;\n* Post-radiation, adjuvant therapy: 150 mg/m\\^2 - 200 mg/m\\^2 orally daily on days 1 - 5 of each cycle.", "OtherNames": [ "Temodar", "Temodal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Functional Assessment of Cancer Therapy-Brain (FACT-Br)", "Type": "BEHAVIORAL", "Description": "FACT-Br Quality of Life (QOL) questionnaire to be completed by study patients as protocol specific timepoints", "OtherNames": [ "FACT-Br" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic Radiosurgery Boost", "Type": "RADIATION", "Description": "Patients will undergo SRS boost in a single fraction dose prior to IMRT treatment:\n\nHTV Maximum dimension vs. Prescribed Dose to HTV: ≤ 20 mm = 21 Gy; 21 mm - 30 mm = 18 Gy; 31 mm - 40 mm = 15 Gy.", "OtherNames": [ "SRS Boost" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Simultaneous Integrated Boost", "Type": "RADIATION", "Description": "Treatment shall consist of 60 Gy in 30 fractions to planning target volume (PTV) 60 and 75 Gy in 30 fractions to PTV 75.", "OtherNames": [ "SIB" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "3D MRSI", "Type": "DEVICE", "Description": "Three Dimensional Magnetic Resonance Spectroscopy Imaging (MRSI) during pre-treatment, week 3 during radiation therapy, end of radiation therapy; will include standard gadolinium enhanced MRI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant temozolomide therapy, per protocol.", "OtherNames": [ "3D Magnetic Resonance Spectroscopy Imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Miami", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02478164", "BriefTitle": "Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma", "OfficialTitle": "Phase II Trial of Ponatinib in Patients With Bevacizumab-Refractory Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-07-13", "PrimaryCompletionDate": "2017-07-08", "Interventions": [ { "Name": "Ponatinib", "Type": "DRUG", "Description": null, "OtherNames": [ "ponatinib hydrochloride", "Iclusig" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT04492163", "BriefTitle": "Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM", "OfficialTitle": "EF-33: An Open-Label Pilot Study of OPTUNE® (TTFields, 200 Khz) With High Density Transducer Arrays for the Treatment of Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-07-14", "PrimaryCompletionDate": "2023-06-20", "Interventions": [ { "Name": "TTFields", "Type": "DEVICE", "Description": "TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.\n\nOther Names:\n\n• TTFields", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NovoCure GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03197506", "BriefTitle": "Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma", "OfficialTitle": "Phase II Study of Pembrolizumab (MK-3475) in Combination With Standard Therapy for Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-01-15", "PrimaryCompletionDate": "2024-07-16", "Interventions": [ { "Name": "External Beam Radiation Therapy", "Type": "RADIATION", "Description": "Undergo external beam radiation therapy", "OtherNames": [ "Definitive Radiation Therapy", "EBRT", "External Beam Radiation", "External Beam Radiotherapy", "External Beam RT", "external radiation", "External Radiation Therapy", "external-beam radiation", "Radiation, External Beam", "Teleradiotherapy", "Teletherapy", "Teletherapy Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04238819", "BriefTitle": "A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma", "OfficialTitle": "A Phase 1b/2 Study of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination With Temozolomide (Part B) in Pediatric and Young Adult Patients With Relapsed/Refractory Solid Tumors and Abemaciclib in Combination With Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients With Relapsed/Refractory Neuroblastoma (Part C)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-11-09", "PrimaryCompletionDate": "2024-03-15", "Interventions": [ { "Name": "Abemaciclib", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [ "LY2835219" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Administered IV", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "Dinutuximab", "Type": "DRUG", "Description": "Administered IV", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "GM-CSF", "Type": "DRUG", "Description": "Administered SC", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "NCTId": "NCT01535911", "BriefTitle": "Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors", "OfficialTitle": "Pilot Study of a Metabolic Nutritional Therapy for the Management of Primary Brain Tumors", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2012-04-01", "PrimaryCompletionDate": "2026-06-01", "Interventions": [ { "Name": "Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)", "Type": "OTHER", "Description": "Adult subjects with newly diagnosed glioblastoma will be referred to the study. Residual tumor size will be determined using MRI imaging. Subjects will be placed on ERKD while they are being treated with radiation therapy and standard of care chemotherapy. After completion of radiation therapy, tumor size will be determined using MRI. If the tumor has decreased in size or remained the same (stable disease), the subjects will be continued on the ERKD for an additional 6 weeks. Total calories consumed by each subject will be targeted to 20 to 25 kcal/kg/day. If the tumor has decreased in size or the size has remained the same then subjects will be continued on the ERKD for as additional 6 weeks and a repeat MRI will be obtained.", "OtherNames": [ "Ketogenic diet" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Michigan State University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Sparrow Health System" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01491893", "BriefTitle": "PVSRIPO for Recurrent Glioblastoma (GBM)", "OfficialTitle": "Dose-finding and Safety Study of an Oncolytic Polio/Rhinovirus Recombinant Against Recurrent WHO Grade IV Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-04-25", "PrimaryCompletionDate": "2017-06-27", "Interventions": [ { "Name": "Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)", "Type": "BIOLOGICAL", "Description": "Recombinant nonpathogenic polio-rhinovirus chimera (PVSRIPO)", "OtherNames": [ "Live attenuated, oral (Sabin) serotype 1 poliovirus vaccine" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Istari Oncology, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)", "Brain Tumor Research Charity Grant", "Duke University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02431572", "BriefTitle": "A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy", "OfficialTitle": "A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2015-05", "PrimaryCompletionDate": "2019-02", "Interventions": [ { "Name": "PBR PET", "Type": "OTHER", "Description": null, "OtherNames": [ "PBR28" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cancer Immunotherapy", "Type": "BIOLOGICAL", "Description": "Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms.", "OtherNames": [ "Checkpoint inhibition; Vaccine" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Radiation and chemotherapy", "Type": "RADIATION", "Description": "Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care.", "OtherNames": [ "Chemoradiation" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01103375", "BriefTitle": "Erlotinib Hydrochloride and Isotretinoin in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase I Single Arm Open Label Study of Erlotinib and 13-cis-Retinoic Acid (CRA) in Patients With Recurrent Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2010-05", "PrimaryCompletionDate": "2013-01", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CP-358,774", "erlotinib", "OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "isotretinoin", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "13-CRA", "Amnesteem", "Cistane", "Claravis", "Sotret" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative study", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "protein expression analysis", "Type": "GENETIC", "Description": "Correlative study", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03631836", "BriefTitle": "Phase I Study of Monoclonal Antibondy (GS) 5745, an Matix Metalloproteinase 9 (MMP9) Mab Inhibitor, in Combination With Bevacizumab in Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase I Study of Monoclonal Antibondy (GS) 5745, an Matix Metalloproteinase 9 (MMP9) Mab Inhibitor, in Combination With Bevacizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2019-01-01", "PrimaryCompletionDate": "2022-01-01", "Interventions": [ { "Name": "Monoclonal antibody", "Type": "DRUG", "Description": "3 doses of Monoclonal antibody could be tested", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "fixed dose of bevacizumab (10 mg/ kg every two weeks)", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Blood sample", "Type": "BIOLOGICAL", "Description": "Evaluate the biomarkers plasma levels during administration of drug", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Dynamic Contrast Enhanced magnetic resonance imaging (DCE-MRI)", "Type": "DEVICE", "Description": "Assess antiangiogenic effects by DCE-MRI", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Assistance Publique Hopitaux De Marseille", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01086345", "BriefTitle": "Radiosurgery Plus Bevacizumab in Glioblastoma", "OfficialTitle": "Phase I/II Trial of Radiosurgery Plus Bevacizumab in Patients With Recurrent/Progressive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2010-02", "PrimaryCompletionDate": "2014-12", "Interventions": [ { "Name": "radiosurgery", "Type": "RADIATION", "Description": "Patients undergo radiosurgery 10-14 days after beginning bevacizumab.", "OtherNames": [ "Radiation Surgery" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "anti-VEGF rhuMAb", "Avastin", "recombinant humanized anti-VEGF monoclonal antibody", "rhuMAb VEGF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Campto", "Camptosar", "camptothecin-11", "CPT-11", "irinotecan", "U-101440E" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03600467", "BriefTitle": "Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive Glioblastoma", "OfficialTitle": "A Single-arm, Open-label, Signal-seeking, Phase IIa Trial of the Activity of Seviteronel in Patients With Androgen Receptor (AR)-Positive GBM", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2018-08-13", "PrimaryCompletionDate": "2021-02-28", "Interventions": [ { "Name": "SEVI-D (Seviteronel in combination with dexamthasone)", "Type": "DRUG", "Description": "Use of SEVI-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.\n\nSerivteronel will be administered orally at 450 mg (3 tables) once daily. It will be given in combination with one oral tablet of 0.5 mg tablet of Dexamethosone. SEVI-D will be continuously administered daily while on the study.\n\nClinical and safety assessments are scheduled every 4 weeks during the study and then every 8 weeks after the end of the safety follow up period of the study.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "St Vincent's Hospital, Sydney", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02525692", "BriefTitle": "Oral ONC201 in Adult Recurrent Glioblastoma", "OfficialTitle": "Oral ONC201 in Adult Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2016-01", "PrimaryCompletionDate": "2023-04-17", "Interventions": [ { "Name": "Dordaviprone (ONC201)", "Type": "DRUG", "Description": "Dordaviprone (ONC201) is a brain-penetrant, small-molecule imipridone that acts as a mitochondrial caseinolytic protease P (ClpP) agonist and a dopamine receptor D2 (DRD2) antagonist.", "OtherNames": [ "Dordaviprone" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jazz Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Oncoceutics, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02498665", "BriefTitle": "A Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies", "OfficialTitle": "A Phase I Clinical Study of DSP-7888 Dosing Emulsion in Adult Patients With Advanced Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-11", "PrimaryCompletionDate": "2018-08", "Interventions": [ { "Name": "DSP-7888 Dosing Emulsion", "Type": "DRUG", "Description": "Dose escalation cohort: Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase.\n\nMDS cohort 1: Patients will be intradermally administered of DSP-7888 at 10.5 mg every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks.\n\nMDS cohort 2: Patients will be intradermally administered of DSP-7888 at 10.5 mg every 2 weeks until Week 24, and then every 4 weeks.", "OtherNames": [ "adegramotide and nelatimotide" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sumitomo Pharma America, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05835687", "BriefTitle": "Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors", "OfficialTitle": "Loc3CAR: Locoregional Delivery of B7-H3-specific Chimeric Antigen Receptor Autologous T Cells for Pediatric Patients With Primary CNS Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-27", "PrimaryCompletionDate": "2028-03", "Interventions": [ { "Name": "B7-H3-CAR T cells", "Type": "DRUG", "Description": "Autologous T cells transduced with a lentiviral vector expressing a B7-H3-CAR with a CD28z signaling domain and 41BB ligand (B7-H3-CAR T cells). Four (4) infusions of B7-H3-CAR T cells will be locoregionally administered via CNS reservoir catheter.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03893487", "BriefTitle": "Fimepinostat in Treating Brain Tumors in Children and Young Adults", "OfficialTitle": "A Target Validation Study of Fimepinostat in Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG), Recurrent Medulloblastoma, or Recurrent High-Grade Glioma (HGG)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2019-08-07", "PrimaryCompletionDate": "2022-10-31", "Interventions": [ { "Name": "Fimepinostat", "Type": "DRUG", "Description": "Fimepinostat capsules", "OtherNames": [ "CUDC-907" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sabine Mueller, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pediatric Neuro-Oncology Consortium", "Cannonball Kids' Cancer Foundation", "Curis, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00047281", "BriefTitle": "Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma", "OfficialTitle": "Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-03", "PrimaryCompletionDate": "2005-08", "Interventions": [ { "Name": "celecoxib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "thalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Schering-Plough", "Celgene" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02430363", "BriefTitle": "Evaluation Of The Treatment Effectiveness Of Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475", "OfficialTitle": "Phase IIb Trial Evaluations Of The Effectiveness Of Treatment Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475 (Pembrolizumab)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-03", "PrimaryCompletionDate": "2016-01", "Interventions": [ { "Name": "MK - 3475", "Type": "DRUG", "Description": "Administered Intravenously", "OtherNames": [ "Pembrolizumab", "Keytruda" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "PI3K" ], "classes": [] } }, { "Name": "Suppressor of the PI3K/Akt pathways", "Type": "BIOLOGICAL", "Description": "Capsules orally with food", "OtherNames": [ "Pictilisib", "GDC-0941", "BEZ235", "NVP-BEZ235", "Ipatasertib", "GDC-0068" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "PI3K" ], "classes": [] } } ], "LeadSponsorName": "Medical Research Council", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "Aarhus University Hospital", "NCRI Clinical Studies Groups", "ECCO - the European CanCer Organisation", "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "PI3K" ], "classes": [] } }, { "NCTId": "NCT04734444", "BriefTitle": "SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue", "OfficialTitle": "Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2021-09-01", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "SonoClear ACF", "Type": "DEVICE", "Description": "The SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "SonoClear AS", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00305864", "BriefTitle": "Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-02-09", "PrimaryCompletionDate": "2011-02-16", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiotherapy", "OtherNames": [ "3-dimensional radiation therapy", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Motexafin Gadolinium", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "API-GP3", "gadolinium texaphyrin", "Gd (III) Texaphryin", "Gd-Tex", "PCI-0120", "Xcytrin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "Radiation Therapy Oncology Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05818865", "BriefTitle": "\"Principle Test\" for Isolation and Characterization of Circulating Cancer Cells (CTC)-CXCR4+.", "OfficialTitle": "\"Principle Test\" for Isolation and Characterization of Cancer Cells (CTC)-CXCR4+ Circulating in Belotero Loaded With CXCL12 in Patients With Solid Neoplasms (Endometrium, Kidney, Glioblastoma, Colorectal, Ovary and Lung).", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2021-01-18", "PrimaryCompletionDate": "2022-03-22", "Interventions": [ { "Name": "CLG", "Type": "DEVICE", "Description": "The development of an innovative device (CLG) consisting of an aqueous gel based on hyaluronic acid and commercially available (Belotero) able to be loaded and to release chemokine CXCL12 recreating a kind of \"fake niche\" able to attract immune cells- and CTCs-CXCR4+. The added value is the ability to attract and trap cells capable of leaking out and potentially with a higher metastatic capacity.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute, Naples", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00005083", "BriefTitle": "Functional Magnetic Resonance Imaging and 1H-Nuclear Magnetic Resonance Spectroscopic Imaging in Treating Patients With Newly Diagnosed Brain Tumors", "OfficialTitle": "Defining Functional Tissue in Brain Tumors With Integrated Neuroimaging (Pilot Study)", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "1998-03", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance spectroscopic imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00087451", "BriefTitle": "Safety Study of AP23573 in Patients With Progressive or Recurrent Glioma (8669-023)(COMPLETED)", "OfficialTitle": "A Phase I Sequential Ascending Dose Trial of AP23573 in Patients With Progressive or Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-07", "PrimaryCompletionDate": "2005-11", "Interventions": [ { "Name": "AP23573", "Type": "DRUG", "Description": "ridaforolimus", "OtherNames": [ "deforolimus", "MK-8669", "ridaforolimus was also known as deforolimus until May 2009" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Ariad Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05447195", "BriefTitle": "Phase 2 Study of CAN008 in Subjects With GBM", "OfficialTitle": "A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-10-10", "PrimaryCompletionDate": "2024-01-31", "Interventions": [ { "Name": "CAN008", "Type": "DRUG", "Description": "Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given CAN008 + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the CAN008+TMZ maintenance therapy period in which subjects in both groups are given CAN008+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given CAN008 IV infusion weekly until disease progression.", "OtherNames": [ "APG101" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given placebo + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the placebo+TMZ maintenance therapy period in which subjects in both groups are given placebo+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given placebo IV infusion weekly until disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CANbridge Life Sciences Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03419403", "BriefTitle": "UNITE Study: Understanding New Interventions With GBM ThErapy", "OfficialTitle": "Phase 3b Study for Management of Ocular Side Effects in Subjects With EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2018-07-30", "PrimaryCompletionDate": "2019-09-05", "Interventions": [ { "Name": "Steroid eye drops", "Type": "DRUG", "Description": "Solution, eye drop", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Vasoconstrictor eye drops", "Type": "DRUG", "Description": "Solution, eye drop", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Cold compress", "Type": "OTHER", "Description": "Cold compress", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Ophthalmic steroid ointment", "Type": "DRUG", "Description": "Ointment", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Depatuxizumab mafodotin", "Type": "DRUG", "Description": "During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.", "OtherNames": [ "ABT-414" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01865162", "BriefTitle": "Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study", "OfficialTitle": "Ketogenic Diet as Adjunctive Treatment in Refractory/End-stage Glioblastoma Multiforme: a Pilot Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-01", "PrimaryCompletionDate": "2021-01", "Interventions": [ { "Name": "ketogenic diet", "Type": "OTHER", "Description": "Treatment will consist of ketogenic diet. KD will consist of 4:1 \\[fat\\] : \\[protein+carbohydrate\\] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mid-Atlantic Epilepsy and Sleep Center, LLC", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Pittsburgh Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00089427", "BriefTitle": "IL13-PE38QQR Infusion After Tumor Resection, Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Malignant Glioma", "OfficialTitle": "Phase I Study of Convection Enhanced Delivery (CED) of IL13-PE38QQR Infusion After Resection Followed by Radiation Therapy With or Without Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-07", "PrimaryCompletionDate": "2007-07", "Interventions": [ { "Name": "IL13-PE38QQR", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Surgery for placement", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide with radiation therapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00445588", "BriefTitle": "Erlotinib and Sorafenib in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of Erlotinib (OSI-774) and Sorafenib (BAY 43-9006) for Patients With Progression or Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-01", "PrimaryCompletionDate": "2009-08", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "150mg Given orally once daily", "OtherNames": [ "OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "sorafenib tosylate", "Type": "DRUG", "Description": "400mg Given orally twice daily", "OtherNames": [ "BAY 3-9006" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00047294", "BriefTitle": "Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-04", "PrimaryCompletionDate": "2005-03", "Interventions": [ { "Name": "celecoxib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "thalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00694837", "BriefTitle": "Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma", "OfficialTitle": "Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-03", "PrimaryCompletionDate": "2013-01", "Interventions": [ { "Name": "nelfinavir", "Type": "DRUG", "Description": "The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Maastricht Radiation Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "Maastricht University Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00036972", "BriefTitle": "Immunotoxin Therapy Before and After Surgery in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I Study to Assess the Histologic Effect and Safety of Pre-Operative and Post-Operative Infusions of IL13-PE38QQR Cytotoxin in Patients With Recurrent Resectable Supratentorial Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2001-11", "PrimaryCompletionDate": "2005-01", "Interventions": [ { "Name": "cintredekin besudotox", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "neoadjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00433381", "BriefTitle": "Bevacizumab and Irinotecan or Temozolomide in Treating Patients With Recurrent or Refractory Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "A Randomized Phase II Trial of Bevacizumab With Irinotecan or Bevacizumab With Temozolomide in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-03-01", "PrimaryCompletionDate": "2010-01-21", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF rhuMAb", "Avastin", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar FKB238", "BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan Hydrochloride", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Campto", "Camptosar", "Camptothecin 11", "Camptothecin-11", "CPT 11", "CPT-11", "Irinomedac", "U-101440E" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "American College of Radiology Imaging Network", "Radiation Therapy Oncology Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01905228", "BriefTitle": "A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm", "OfficialTitle": "A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-07", "PrimaryCompletionDate": "2019-05", "Interventions": [ { "Name": "CBL0137", "Type": "DRUG", "Description": "All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle.\n\nNumber of Cycles: 2 or until progression or unacceptable toxicity develops", "OtherNames": [ "Curaxin" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Incuron", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04477200", "BriefTitle": "Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma", "OfficialTitle": "Phase 0/I Dose Escalation Study of Mycophenolate Mofetil Combined With Radiation Therapy in Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-08-05", "PrimaryCompletionDate": "2025-01-06", "Interventions": [ { "Name": "Mycophenolate Mofetil", "Type": "DRUG", "Description": "500-2000mg orally twice daily, one week prior to re-resection (2 participants at each of 4 dose levels: 500mg, 1000mg, 1500mg and 2000mg)", "OtherNames": [ "MMF" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "40.5 Gy in 15 fractions", "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Re-resection (as part of standard of care)", "Type": "PROCEDURE", "Description": "Re-resection or biopsy of tumor as part of standard of care", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide capsules are an approved oral chemotherapeutic drug for the treatment of adult patients with newly diagnosed GBM/GS concomitantly with radiotherapy and then as adjuvant treatment. The dosing and timing of temozolomide therapy will be determined as per standard-of-care for the individual patient by the treating oncologist.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Mycophenolate Mofetil", "Type": "DRUG", "Description": "250-2000mg orally twice daily, one week prior to and concurrent with RT.", "OtherNames": [ "MMF" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Mycophenolate Mofetil", "Type": "DRUG", "Description": "250-2000mg orally twice daily, one week prior to and concurrent with RT and cyclic chemotherapy with temozolomide.", "OtherNames": [ "MMF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "60 Gy in 30 fractions", "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Michigan Rogel Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05226494", "BriefTitle": "Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma", "OfficialTitle": "A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-06-23", "PrimaryCompletionDate": "2026-10", "Interventions": [ { "Name": "fb-PMT", "Type": "DRUG", "Description": "Daily dosing based on patient weight", "OtherNames": [ "NP-100", "NP751" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NanoPharmaceuticals LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02031965", "BriefTitle": "Oncolytic HSV-1716 in Treating Younger Patients With Refractory or Recurrent High Grade Glioma That Can Be Removed By Surgery", "OfficialTitle": "A Phase I Study of Intratumoral/Peritumoral Herpes Simplex Virus-1 Mutant HSV1716 in Patients With Refractory or Recurrent High Grade Gliomas (HGG)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2013-12", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "oncolytic HSV-1716", "Type": "BIOLOGICAL", "Description": "Given IT", "OtherNames": [ "herpes simplex virus 1716" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "dexamethasone", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Aeroseb-Dex", "Decaderm", "Decadron", "DM", "DXM" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00006353", "BriefTitle": "Radiation Therapy With or Without Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Concomitant and Adjuvant Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma Multiforme - A Randomized Phase III Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2000-07", "PrimaryCompletionDate": "2002-03", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "NCIC Clinical Trials Group" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00807027", "BriefTitle": "Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea", "OfficialTitle": "Multi-center, Randomized, Open-label Phase 3 Clinical Trial to Assess the Efficacy and Safety of 'INNOCELL Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2008-12-05", "PrimaryCompletionDate": "2012-10", "Interventions": [ { "Name": "Activated T lymphocyte(Immuncell-LC)", "Type": "DRUG", "Description": "Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention\n\nMethod of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "GC Cell Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05108012", "BriefTitle": "Nk Cell Therapy for Recurrent Glioblastoma Multiform Patients", "OfficialTitle": "The Safety Evaluation of Ex Vivo Activated Haploidentical Natural Killer Cells (NK) in Recurrent Glioblastoma Multiform Patients (Clinical Trial Phase I)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2021-08-01", "PrimaryCompletionDate": "2021-11", "Interventions": [ { "Name": "NK cell therapy", "Type": "BIOLOGICAL", "Description": "Activated NK cell injection in tumor cavity of patient with GBM (Glioblastoma Multiform)", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Royan Institute", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "Tehran University of Medical Sciences" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006102", "BriefTitle": "Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma", "OfficialTitle": "A Phase II Trial of Rebeccamycin Analogue (NSC #655649) in Children With Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-07", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "becatecarin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00526812", "BriefTitle": "A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I Dose-finding and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent or Refractory Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Anaplastic Mixed Oligo-astrocytoma (AOA), Glioblastoma Multiforme (GBM) or Gliosarcoma (GS), With or Without Concurrent Treatment With Enzyme-inducing Anticonvulsant Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-11-30", "PrimaryCompletionDate": "2008-12-01", "Interventions": [ { "Name": "RTA 744", "Type": "DRUG", "Description": "Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "RTA 744 injection", "Type": "DRUG", "Description": "Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Biogen", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04845919", "BriefTitle": "Sonodynamic Therapy with ExAblate System in Glioblastoma Patients", "OfficialTitle": "A Pilot Study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2023-02-22", "PrimaryCompletionDate": "2024-10-30", "Interventions": [ { "Name": "5-Aminolevulinic Acid", "Type": "DRUG", "Description": "SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 \"Neuro-System\".", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00544284", "BriefTitle": "Bortezomib and Temozolomide in Treating Patients With Brain Tumors or Other Solid Tumors That Have Not Responded to Treatment", "OfficialTitle": "A Phase I Study of Bortezomib and Temozolomide in Patients With Refractory Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "bortezomib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06016452", "BriefTitle": "A Study of Chlorophyllin for the Management of Brain Radio-necrosis in Patients With Diffuse Glioma", "OfficialTitle": "A Prospective Phase 2 Study of Chlorophyllin for the Management of Brain Radionecrosis in Patients With Diffuse Glioma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-11-13", "PrimaryCompletionDate": "2025-11", "Interventions": [ { "Name": "Chlorophyllin", "Type": "DRUG", "Description": "Chlorophyllin is a water-soluble compound obtained from the green plant pigment called chlorophyll. It has been shown to have anti-cancer, anti-bacterial, anti-viral, anti-inflammatory, and antioxidant properties. It is also used as an oral formulation and is an over-the-counter drug in various countries, and also as a food coloring agent.", "OtherNames": [ "Stratum A (Symptomatic)", "Stratum A (Asymptomatic)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tata Memorial Centre", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bhabha Atomic Research Centre (BARC)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01132547", "BriefTitle": "Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer", "OfficialTitle": "Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2010-06", "PrimaryCompletionDate": "2014-01", "Interventions": [ { "Name": "cyproheptadine hydrochloride", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "cyproheptadine HCl" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "placebo", "Type": "OTHER", "Description": "Given orally", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of South Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03633552", "BriefTitle": "Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma", "OfficialTitle": "A Single-blind, Randomized, Clinical Trial Comparing the Efficacy of 6 Cycles Versus 12 Cycles Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2018-03-03", "PrimaryCompletionDate": "2021-03-03", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).", "OtherNames": [ "Temodar, Temodal, Temcad, Glidar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mashhad University of Medical Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00068952", "BriefTitle": "Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase III, Randomized, Open-Label Study Of IV Edotecarin Vs Temozolomide Or Carmustine (BCNU) Or Lomustine (CCNU) In Patients With Glioblastoma Multiforme At First Relapse After Alkylator-Based (NEO) Adjuvant Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2003-08", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Edotecarin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Carmustine (BCNU)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine (CCNU)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Pfizer", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06625047", "BriefTitle": "Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy", "OfficialTitle": "Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE4" ], "StartDate": "2024-10-07", "PrimaryCompletionDate": "2025-11-12", "Interventions": [ { "Name": "Assessment", "Type": "BEHAVIORAL", "Description": "Complete in-person assessment visits", "OtherNames": [ "Assess", "Study Assessment", "Study Observation" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Telemedicine Visit", "Type": "OTHER", "Description": "Complete telehealth assessment visits", "OtherNames": [ "Telemedicine Encounter" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00098761", "BriefTitle": "VNP40101M in Treating Young Patients With Recurrent, Progressive, or Refractory Primary Brain Tumors", "OfficialTitle": "Phase I Study Of Cloretazine (VNP40101M) In Children With Recurrent, Progressive Or Refractory Primary Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-02", "PrimaryCompletionDate": "2006-10", "Interventions": [ { "Name": "laromustine", "Type": "DRUG", "Description": "This is a dose escalation study. Participants receive 20, 30, 45, 60, 78, 103, 137, 182, or 242 mg/m2/day intravenously over 30 minutes for 5 consecutive days every 6 weeks up to 48 weeks.", "OtherNames": [ "Cloretazine", "VNP40101M" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01999270", "BriefTitle": "Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors", "OfficialTitle": "Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors, A Feasibility Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-04", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "Irinotecan", "Type": "DRUG", "Description": "Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29)\n\nNote: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.", "OtherNames": [ "Camptosar®", "CPT-11" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.", "OtherNames": [ "Avastin®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "FDOPA-PET/MRI imaging", "Type": "DEVICE", "Description": "FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06356883", "BriefTitle": "Intraarterial Carboplatin + Caelyx vs Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma", "OfficialTitle": "A Randomized Phase II Study on Intraarterial Carboplatin Combined With Caelyx Compared to Intraarterial Carboplatin Combined With Etoposide Phosphate for Progressing Glioblastoma at First or Second Relapse", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-08", "PrimaryCompletionDate": "2027-04", "Interventions": [ { "Name": "IA Carboplatin + IA Caelyx", "Type": "DRUG", "Description": "Intraarterial infusion of carboplatin combined with liposomal doxorubicin", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "IA Carboplatin + IA Etoposide Phosphate", "Type": "DRUG", "Description": "Intraarterial infusion of carboplatin combined with etoposide phosphate", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Université de Sherbrooke", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01102595", "BriefTitle": "Neo-adjuvant Treatment With Temozolomide and Bevacizumab Previous to Temozolomide Plus Radiation Plus Bevacizumab Therapy in Unresectable Glioblastoma", "OfficialTitle": "A Phase II Open Label Randomised Multicentric Study in Patients With Unresectable Glioblastoma Using Neo-adjuvant Treatment With Two Cycles of Temozolomide Previous Temozolomide Plus Radiation Therapy and Adjuvant Temozolomide vs. Neo-adjuvant Treatment With Two Cycles of Temozolomide Plus Bevacizumab Previous Temozolomide, Bevacizumab and Radiation Therapy and Adjuvant Temozolomide.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-12", "PrimaryCompletionDate": "2013-10", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "* Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles.\n* Temozolomide 75 mg/m2/d x 42-49 days\n* Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "* 2 cycles + bevacizumab 10 mg/kg every 15 days each two cycles.\n* Bevacizumab 10 mg/kg every 15 days, three dosis.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Standard radiation therapy", "Type": "RADIATION", "Description": "42-49 days with standard radiation therapy (60 Gy): 2 Gy per day.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01105988", "BriefTitle": "Evaluating Tumor Pseudoprogression With FLT-PET and MRI", "OfficialTitle": "A Pilot Study to Evaluate Tumor Pseudoprogression With FLT-PET and MRI", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2011-10", "Interventions": [ { "Name": "Radiologic exams", "Type": "OTHER", "Description": "FLT PET scan x 2 MRI scan x 2", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dana-Farber Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02530502", "BriefTitle": "Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I Trial of Radiation Therapy Plus Temozolomide With MK-3475 in Patients With Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2015-09-30", "PrimaryCompletionDate": "2016-05-10", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo focal RT", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "Irradiated", "Irradiation", "RADIATION", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temodal", "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01269853", "BriefTitle": "Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA", "OfficialTitle": "Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2026-10", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Experimental portion of this proposal:\n\nThis trial will have two experimental arms that will be open labeled and non-randomized.\n\nARM 1 (If the patient has multifocal disease or leptomeningeal disease)\n\nDay 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until disease progression on MRI scan.\n\nIf progression occurs, repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until progression on MRI scan.\n\nRepeat Cycle", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "ARM 2 (If the patient has no multifocal disease or leptomeningeal disease)\n\nDay 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: No biweekly IV Bevacizumab treatment\n\nIf MRI shows progression then repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression Repeat Cycle", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "Feinstein Institute for Medical Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00376103", "BriefTitle": "Radiation Boost for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I/II Trial of Maximal Resection, Local Radiation Boost With Concomitant Temozolomide, Followed by External Radiation Therapy With Concomitant Temozolomide for the Treatment of Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-08", "PrimaryCompletionDate": "2008-03", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "75 mg/m2/day", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Brachytherapy", "Type": "PROCEDURE", "Description": "60 Gy to 1 cm", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "External Beam Radiation Therapy", "Type": "PROCEDURE", "Description": "60 Gy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Methodist Healthcare", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04952571", "BriefTitle": "Combined Treatment of Camrelizumab and Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)", "OfficialTitle": "An Exploratory Study on Camrelizumab Combined with Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2021-06-27", "PrimaryCompletionDate": "2022-12-31", "Interventions": [ { "Name": "Camrelizumab and Bevacizumab", "Type": "DRUG", "Description": "Stage 1: Targeted therapy induction phase: bevacizumab 5mg/kg, intravenous infusion, once every two weeks, 2 cycles in total.\n\nPhase 2: Targeted combined immunotherapy: once every three weeks with the following drugs: (1) bevacizumab 7.5mg/kg intravenously;(2) Carrelizumab: 200mg/ time, intravenous infusion.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Beijing Sanbo Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00883298", "BriefTitle": "Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-04", "PrimaryCompletionDate": "2014-12", "Interventions": [ { "Name": "temozolomide and bevacizumab", "Type": "DRUG", "Description": "oral temozolomide 100 mg/m2 days 1-5 \\& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \\& 5 every 28-day cycle", "OtherNames": [ "Temodar", "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Center for Neurosciences, Tucson", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00316849", "BriefTitle": "Temsirolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I Study of CCI-779, and Temozolomide in Combination With Radiation Therapy in Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-05", "PrimaryCompletionDate": "2010-11", "Interventions": [ { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "3-dimensional conformal radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "3D conformal radiation therapy", "3D-CRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "intensity-modulated radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "IMRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temsirolimus", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CCI-779", "cell cycle inhibitor 779", "Torisel" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "NCTId": "NCT03607643", "BriefTitle": "A Study of the Efficacy of Cannabidiol in Patients With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies", "OfficialTitle": "Randomized Double-Blind, Placebo-Controlled Parallel Multi-Center Study to Assess the Efficacy of Cannabidiol (BRCX014) Combined With Standard-Of-Care Treatment in Subjects With Multiple Myeloma, Glioblastoma Multiforme, and GI Malignancies", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-01-15", "PrimaryCompletionDate": "2020-06-30", "Interventions": [ { "Name": "Cannabidiol", "Type": "DRUG", "Description": "* Sublingual dose of 1 mL (0.910 g) of BRCX014 in the morning, prior to the first meal of the day\n* Sublingual dose of 1 mL (0.910 g) of BRCX014 in the afternoon, prior to the evening meal", "OtherNames": [ "BRCX014", "bioRenovate CX" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Bortezomib", "Type": "DRUG", "Description": "Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 \\& 11 schedule to be repeated every 21 days.", "OtherNames": [ "Velcade" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Leucovorin", "Type": "DRUG", "Description": "Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.", "OtherNames": [ "Folinic acid" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "5-FU", "Type": "DRUG", "Description": "Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.", "OtherNames": [ "Efudex" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Oxaliplatin", "Type": "DRUG", "Description": "Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.", "OtherNames": [ "Eloxatin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.", "OtherNames": [ "Camptosar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Gemcitabine", "Type": "DRUG", "Description": "Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.", "OtherNames": [ "Gemzar" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Leaf Vertical Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02977689", "BriefTitle": "Trial of IDH305 in IDH1 Mutant Grade II or III Glioma", "OfficialTitle": "Phase 2 Study of IDH305 in Subjects With IDH1 Mutant Grade II or III Glioma That Has Progressed After Observation or Radiation Therapy", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2018-04", "PrimaryCompletionDate": "2020-04", "Interventions": [ { "Name": "IDH305", "Type": "DRUG", "Description": "study drug used to inhibit IDH1 mutation in these tumors, resulting in anti-tumor activity.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT00004068", "BriefTitle": "Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor", "OfficialTitle": "Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-03", "PrimaryCompletionDate": "2003-04", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02330991", "BriefTitle": "A Trial of One-week on/One-week Off Temozolomide Versus Continuous Dose-Intense Temozolomide in Patients With Glioblastoma Multiforme at First Relapse", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-01", "PrimaryCompletionDate": "2020-03", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodal" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Beijing Sanbo Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02152982", "BriefTitle": "Temozolomide With or Without Veliparib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2014-12-15", "PrimaryCompletionDate": "2021-12-01", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo Administration", "Type": "OTHER", "Description": "Given PO", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Veliparib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ABT 888", "ABT-888", "ABT888", "PARP-1 inhibitor ABT-888" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PARP" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PARP" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03661723", "BriefTitle": "Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma", "OfficialTitle": "Phase II Trial of Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-09-28", "PrimaryCompletionDate": "2021-12-09", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system", "OtherNames": [ "Keytruda" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab (also known as \"Avastin\") is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Re-irradiation", "Type": "RADIATION", "Description": "Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02052648", "BriefTitle": "Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors", "OfficialTitle": "A Phase I/II Study of the Combination of Indoximod and Temozolomide for Adult Patients With Temozolomide-Refractory Primary Malignant Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-03", "PrimaryCompletionDate": "2018-04-18", "Interventions": [ { "Name": "Indoximod", "Type": "DRUG", "Description": null, "OtherNames": [ "1-methyl-D-tryptophan", "D-1MT" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodar", "Methazolastone" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Stereotactic Radiation", "Type": "RADIATION", "Description": null, "OtherNames": [ "SRS or SRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NewLink Genetics Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01562197", "BriefTitle": "A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma", "OfficialTitle": "A Randomized Phase II Clinical Trial on the Efficacy of Axitinib as a Monotherapy or in Combination With Lomustine for the Treatment of Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-04", "PrimaryCompletionDate": "2018-08", "Interventions": [ { "Name": "axitinib", "Type": "DRUG", "Description": "The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.", "OtherNames": [ "Inlyta (TM)" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Axitinib plus Lomustine", "Type": "DRUG", "Description": "Lomustine 90mg/m²", "OtherNames": [ "CCNU" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Bart Neyns", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT03616860", "BriefTitle": "Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma", "OfficialTitle": "Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier Disruption for the Treatment of High Grade Glioma in Patients Undergoing Standard Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2018-10-16", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Focused Ultrasound (FUS) BBB Disruption", "Type": "DEVICE", "Description": "FUS BBB disruption involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets", "OtherNames": [ "Exablate Neuro" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00939991", "BriefTitle": "Suberoylanilide Hydroxamic Acid (SAHA), Bevacizumab, Daily Temozolomide for Recurrent Malignant Gliomas", "OfficialTitle": "Phase I/II Study of Bevacizumab Plus Daily Temozolomide and Vorinostat for Recurrent Malignant Glioma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-10", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "Vorinostst/Bevacizumab/Temozolomide", "Type": "DRUG", "Description": "Bevacizumab will be administered intravenously at the dose 10 mg/kg every other week. Temozolomide will be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat will be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat will be escalated in successive cohorts of patients to determine the MTD of this regimen. Bevacizumab doses may be given by the local oncologists under the direction of the Duke investigators.", "OtherNames": [ "Bevacizumab (Avastin)", "Temozolomide (Temodar)", "Vorinostat (Zolinza)" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Katy Peters", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03746080", "BriefTitle": "Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma", "OfficialTitle": "A Follow-Up Study to Add Whole Brain Radiotherapy (WBRT) to Standard Temozolomide Chemo-Radiotherapy in Newly Diagnosed Glioblastoma (GBM) Treated With 4 Weeks of Continuous Infusion Plerixafor", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-12-04", "PrimaryCompletionDate": "2022-05-31", "Interventions": [ { "Name": "Plerixafor", "Type": "DRUG", "Description": "Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation", "OtherNames": [ "AMD 3100", "JM-3100", "Mozobil", "SDZ SID 791" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) will be administered concurrently with the radiation for 42 days and 6-12 cycles of monthly adjuvant Temozolomide (TMZ) after completion of Plerixafor infusion.", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Whole-Brain Radiotherapy (WBRT)", "Type": "RADIATION", "Description": "Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations", "OtherNames": [ "WBRT", "whole-brain radiation therapy", "whole-brain radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiotherapy consists of 30 Gy in 15 fractions", "OtherNames": [ "XRT", "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Lawrence D Recht", "LeadSponsorClass": "OTHER", "Collaborators": [ "Sanofi" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01421524", "BriefTitle": "Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma", "OfficialTitle": "A Phase 1a/1b, Multi-center, Open-label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-09-12", "PrimaryCompletionDate": "2023-11-21", "Interventions": [ { "Name": "CC-122", "Type": "DRUG", "Description": "CC-122 dose in both arms will increase by 1 mg increments starting with 3 mg 5/7 days using the 3+3 design in dose escalation phase. A dose-level -1, with a starting dose of 2mg, may also be evaluated if the opening dose level is not tolerated. At all dose levels in MM-2b arm, DEX will be combined with CC-122 at a starting dose dependent on the subject's age: for subjects who are ≤ 75 years of age, DEX 40 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle and for subjects who are \\> 75 years of age, DEX 20 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle. Approximately 33 subjects will be enrolled in the dose escalation phase (15 in each treatment arm). An additional intermittent schedule of 21/28 days may be evaluated per Safety Review Committee (SRC) decision. Following dose escalation, one or two arms will be expanded at or below the MTD in up to 28 subjects (14 subjects in each arm).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CC-122", "Type": "DRUG", "Description": "One or more intermittent schedules of CC-122 either given 5 continuous days out of 7 per week (5/7 days) or 21 continuous days out of 28 days per cycle (21/28 days). Following dose escalation, one or more of these intermittent schedules will be evaluated at a starting dose of 4 mg.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CC-122", "Type": "DRUG", "Description": "Dose escalation on a continous schedule will be evaluated at a starting dose of 4 mg. Specifically, dose levels with 1 mg increments (eg 4mg, 5mg, 6mg etc.) will be evaluated using a 3+3 design as detailed in Part A of the protocol .", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CC-122", "Type": "DRUG", "Description": "Up to 10 subjects with relapsed or refractory PCNSL will be enrolled to a PCNSL cohort to evaluate intermittent schedules of CC-122 and to further explore preliminary signals of efficacy and biomarker hypotheses.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01022918", "BriefTitle": "Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma", "OfficialTitle": "Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-01", "PrimaryCompletionDate": "2010-07", "Interventions": [ { "Name": "Avastin + Campto / radiotherapy + Temodal + Avastin (4 cures)", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temodal/radiotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Centre Georges Francois Leclerc", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute, France", "Association de Neuro-Oncologues d'Expression Francaise", "UNICANCER", "Hoffmann-La Roche", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04181684", "BriefTitle": "LITT Followed by Hypofractionated RT for Recurrent Gliomas", "OfficialTitle": "Pilot Study of Laser Interstitial Thermal Therapy Followed By Hypofractionated Radiation Therapy for Treatment of Recurrent Gliomas.", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-01-08", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Procedure: LITT", "Type": "DEVICE", "Description": "This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.", "OtherNames": [ "Laser Interstitial thermal therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Hypo-Fractionated Radiation Therapy", "Type": "RADIATION", "Description": "Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Maryland, Baltimore", "LeadSponsorClass": "OTHER", "Collaborators": [ "Keep Punching Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02410577", "BriefTitle": "89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme", "OfficialTitle": "A Pilot Study of 89Zr-J591 Anti-Prostate-Specific Membrane Antigen Monoclonal Antibody in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2015-04", "PrimaryCompletionDate": "2018-08", "Interventions": [ { "Name": "89Zr-J591", "Type": "DRUG", "Description": "The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET/CT Scan", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MRI", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Blood draw", "Type": "OTHER", "Description": "Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Weill Medical College of Cornell University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00311857", "BriefTitle": "Safety Study of Cetuximab, Radiotherapy and Temozolomide in Primary Glioblastoma Multiforme(GERT)", "OfficialTitle": "Treatment of Primary Glioblastoma Multiforme With Cetuximab, Radiotherapy and Temozolomide (GERT) - Phase I/II Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Cetuximab", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Heidelberg University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck KGaA, Darmstadt, Germany" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00590681", "BriefTitle": "Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Avastin and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme: A Phase II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-02", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Bevacizumab and Temozolomide", "Type": "DRUG", "Description": "This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Chicago", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01966809", "BriefTitle": "Photodynamic Therapy (PDT) For Recurrent High Grade Gliomas", "OfficialTitle": "A Phase II Study of Photodynamic Therapy (PDT) With Photofrin® (IND 104,613) For Recurrent High Grade Gliomas in Adults", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-06", "PrimaryCompletionDate": "2017-12-19", "Interventions": [ { "Name": "Photofrin photodynamic therapy.", "Type": "DRUG", "Description": "The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:\n\nTreatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence. After PDT, the Intralipid solution will be removed and the wound will be closed. The subject will be sent to the intensive care area for recovery.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Harry T Whelan, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pinnacle Biologics Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05283330", "BriefTitle": "Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors", "OfficialTitle": "A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-12-22", "PrimaryCompletionDate": "2027-01", "Interventions": [ { "Name": "²¹²Pb-DOTAM-GRPR1", "Type": "DRUG", "Description": "²¹²Pb-DOTAM-GRPR1 is a radioimmunoconjugate comprised of ²¹²Pb, the metal chelator DOTAM (1,4,7,10-Tetrakis(carbamoylmethyl)-1,4,7,10- tetraazacyclododecane) and a GRPR-targeted antagonist.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Orano Med LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00747253", "BriefTitle": "Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors", "OfficialTitle": "AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-08", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "AutoLITT system", "Type": "DEVICE", "Description": "laser treatment with the AutoLITT system", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Monteris Medical", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04959500", "BriefTitle": "Newly Diagnosed Glioblastoma", "OfficialTitle": "Addition of Anlotinib Hydrochloride to the Stupp Regimen Versus the Stupp Regimen Alone for Newly Diagnosed Glioblastoma: A Randomized Double-blind Multicenter Prospective Phase II Study", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-07-21", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Anlotinib Hydrochloride", "Type": "DRUG", "Description": "Drug: Anlotinib Hydrochloride Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Drug: Placebo Placebo will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiation: Radiation therapy Radiation therapy will be delivered in daily fractions of 1.8-2.0 Gy given 5 days a week for a total of 54-60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Drug: Temozolomide Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sun Yat-sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00354068", "BriefTitle": "Imatinib Mesylate and Temozolomide in Treating Patients With Malignant Glioma", "OfficialTitle": "A Phase I Study of Imatinib Mesylate in Combination With Temozolomide in Patients With Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-07", "PrimaryCompletionDate": "2008-11", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00423735", "BriefTitle": "Dasatinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-01-24", "PrimaryCompletionDate": "2011-03-09", "Interventions": [ { "Name": "Dasatinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BMS-354825", "Sprycel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "Radiation Therapy Oncology Group", "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02337491", "BriefTitle": "Pembrolizumab +/- Bevacizumab for Recurrent GBM", "OfficialTitle": "Phase II Study of Pembrolizumab (MK-3475) With and Without Bevacizumab for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-02-09", "PrimaryCompletionDate": "2016-08-28", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "MK-3475", "SCH 900475" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04729959", "BriefTitle": "Testing the Addition of the Immune Therapy Drugs, Tocilizumab and Atezolizumab, to Radiation Therapy for Recurrent Glioblastoma", "OfficialTitle": "A Safety Run-In and Phase II Study Evaluating the Efficacy, Safety, and Impact on the Tumor Microenvironment of the Combination of Tocilizumab, Atezolizumab, and Fractionated Stereotactic Radiotherapy in Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-03-11", "PrimaryCompletionDate": "2025-06-15", "Interventions": [ { "Name": "Atezolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "MPDL 3280A", "MPDL 328OA", "MPDL-3280A", "MPDL3280A", "MPDL328OA", "RG 7446", "RG-7446", "RG7446", "RO 5541267", "RO-5541267", "RO5541267", "Tecentriq" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood sample and tumor tissue collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Fractionated Stereotactic Radiation Therapy", "Type": "RADIATION", "Description": "Undergo FSRT", "OtherNames": [ "Fractionated Stereotactic Radiotherapy" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Tocilizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Actemra", "IL-6 receptor monoclonal antibodies: tocilizumab", "Immunoglobulin G1, Anti-(Human Interleukin 6 Receptor) (Human-Mouse Monoclonal MRA Heavy Chain), Disulfide with Human-Mouse Monoclonal MRA Kappa-Chain, Dimer", "MRA", "R-1569", "RoActemra" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT02137759", "BriefTitle": "MRSI to Predict Response to RT/TMZ ± Belinostat in GBM", "OfficialTitle": "Quantitative Magnetic Resonance Spectroscopic Imaging (MRSI) to Predict Early Response to Standard Radiation Therapy (RT)/Temozolomide (TMZ) ± Belinostat Therapy in Newly-Diagnosed Glioblastomas (GBM)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2014-05-07", "PrimaryCompletionDate": "2023-08-15", "Interventions": [ { "Name": "Standard Radiation Therapy", "Type": "RADIATION", "Description": "Radiation therapy to 60 Gy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard Temozolomide", "Type": "DRUG", "Description": "Temozolomide given orally", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Belinostat", "Type": "DRUG", "Description": "Belinostat dose to be determined, given intravenously over 30-45 minutes", "OtherNames": [ "Beleodaq", "PXD101" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Johns Hopkins University", "Spectrum Pharmaceuticals, Inc", "National Cancer Institute (NCI)", "National Institute of Neurological Disorders and Stroke (NINDS)", "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00305656", "BriefTitle": "AZD2171 in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study of AZD2171 in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-01", "PrimaryCompletionDate": "2012-04", "Interventions": [ { "Name": "cediranib maleate", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "AZD2171", "Recentin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003751", "BriefTitle": "Penicillamine, Low Copper Diet, and Radiation Therapy in Treating Patients With Glioblastoma", "OfficialTitle": "Phase II Study of Penicillamine and Reduction of Copper for Angiosuppressive Therapy of Adults With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-03", "PrimaryCompletionDate": "2004-06", "Interventions": [ { "Name": "penicillamine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003842", "BriefTitle": "IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma", "OfficialTitle": "A Phase I Study of a Recombinant Chimeric Protein Composed of Circularly Permuted IL-4 and a Mutated Form of the Pseudomonas Exotoxin Termed IL-4(38-37)-PE38KDEL (IL-4 Toxin) for the Treatment of Recurrent Malignant Astrocytoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "1999-03", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "interleukin-4 PE38KDEL cytotoxin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "isolated perfusion", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Barrett Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01854554", "BriefTitle": "Glioblastoma Multiforme (GBM) Proton vs. Intensity Modulated Radiotherapy (IMRT)", "OfficialTitle": "A Prospective Phase II Randomized Trial to Compare Intensity Modulated Proton Radiotherapy (IMPT) vs. Intensity Modulated Radiotherapy (IMRT) for Newly Diagnosed Glioblastoma (WHO Grade IV)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-05-17", "PrimaryCompletionDate": "2021-10-13", "Interventions": [ { "Name": "IMPT", "Type": "RADIATION", "Description": "IMPT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.", "OtherNames": [ "Radiotherapy", "XRT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "IMRT", "Type": "RADIATION", "Description": "IMRT treatments delivered as once daily fractions, 5 days per week Monday - Friday for 30 treatments.", "OtherNames": [ "Radiotherapy", "XRT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cognitive Tests", "Type": "BEHAVIORAL", "Description": "Cognitive tests given at baseline, 4 months, then every 2 months for 2 years.", "OtherNames": [ "Thinking skills tests" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaires", "Type": "BEHAVIORAL", "Description": "Questionnaires about quality of life and symptoms given at baseline, 4 months, then every 2 months for 2 years.", "OtherNames": [ "Surveys" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04114786", "BriefTitle": "3D Printed Mask for GBM and Brain Mets", "OfficialTitle": "MRI-based Immobilization and Planning: A Feasibility Study of a Novel Inverse Method for CNS Radiotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-09-26", "PrimaryCompletionDate": "2022-10-18", "Interventions": [ { "Name": "3D-printed mask", "Type": "DEVICE", "Description": "After patient is enrolled to the study, patients will have CT Sim. MR Sim (used to create 3D printed mask for intervention arm only) CT sim repeat (for intervention arm only) before start of radiation Patients will be asked to fill out a questionnaire after each CT Scan, and during the first and last week of radiation treatment", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Thermoplastic mask", "Type": "DEVICE", "Description": "Patients will undergo standard of care simulation, planning and treatment with conventional workflow using thermoplastic mask.They will complete the tolerability questionnaire after CT-sim, and towards the end of the first and last week of treatment.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Health Network, Toronto", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04115761", "BriefTitle": "Evaluate the Efficacy and Safety of ADCV01 As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients", "OfficialTitle": "A Phase II, Randomized, Open-Label, Parallel-Group Study to Evaluate the Efficacy and Safety of Autologous Dendritic Cell Vaccination (ADCV01) As an Add-On Treatment for Primary Glioblastoma Multiforme (GBM) Patients", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2019-06-06", "PrimaryCompletionDate": "2026-12-30", "Interventions": [ { "Name": "autologous dendritic cells", "Type": "BIOLOGICAL", "Description": "The total 10 doses (1 mL/dose; 2±0.5 × 10\\^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ever Supreme Bio Technology Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04730869", "BriefTitle": "Metabolic Therapy Program In Conjunction With Standard Treatment For Glioblastoma", "OfficialTitle": "Feasibility, Safety, and Efficacy of a Metabolic Therapy Program in Conjunction With Standard Treatment for Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2021-05-26", "PrimaryCompletionDate": "2025-02-18", "Interventions": [ { "Name": "Standard Treatment Plus Metabolic Therapy Program", "Type": "OTHER", "Description": "See description under \"Arms.\"", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Waikato Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Wellington Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01654497", "BriefTitle": "Dexanabinol in Patients With Brain Cancer", "OfficialTitle": "A Phase I, Sequential Cohort, Open-Label, Dose-escalation Study of the Safety and CNS Pharmacokinetics of Dexanabinol in Patients With Brain Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-06", "PrimaryCompletionDate": "2015-09", "Interventions": [ { "Name": "Dexanabinol", "Type": "DRUG", "Description": "Dexanabinol: intravenous infusion over 3 hours, weekly (i.e., Day 1, 8, 15 and 22 of a 28-day cycle)\n\nNine dosing cohorts are planned, with the option to enroll additional cohorts based on safety and PK data.\n\nDose Level 1: 2 mg/kg\n\nDose Level 2: 4 mg/kg\n\nDose Level 3: 8 mg/kg\n\nDose Level 4: 16 mg/kg\n\nDose Level 5: 24 mg/kg\n\nDose Level 6: 28 mg/kg\n\nDose Level 7: 36 mg/kg\n\nDose Level 8: 40 mg/kg\n\nDose Level 9: 44 mg/kg", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Santosh Kesari, M.D., Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "e-Therapeutics PLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01177397", "BriefTitle": "Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma", "OfficialTitle": "A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-07-20", "PrimaryCompletionDate": "2016-11-15", "Interventions": [ { "Name": "CC-223", "Type": "DRUG", "Description": "Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04074785", "BriefTitle": "Abemaciclib w/Bevacizumab in Recurrent GBM Pts w/Loss of CDKN2A/B or Gain or Amplification of CDK4/6", "OfficialTitle": "Pilot Study of Abemaciclib With Bevacizumab in Recurrent Glioblastoma Patients With Loss of CDKN2A/B or Gain or Amplification of CDK4/6", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2019-12-13", "PrimaryCompletionDate": "2023-10-16", "Interventions": [ { "Name": "Abemaciclib", "Type": "DRUG", "Description": "Abemaciclib 150 mg po bid", "OtherNames": [ "Verzenio" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Cell cycle inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "CDK", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "University of Texas Southwestern Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Cell cycle inhibitor" ] } }, { "NCTId": "NCT02206230", "BriefTitle": "Trial of Hypofractionated Radiation Therapy for Glioblastoma", "OfficialTitle": "A Randomized Controlled Trial of Conventional Versus Hypofractionated Radiation Therapy With Temozolomide for Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-09-25", "PrimaryCompletionDate": "2023-02-14", "Interventions": [ { "Name": "Hypofractionated radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cross Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06368934", "BriefTitle": "Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma", "OfficialTitle": "Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma: A Prospective, Interventional, Multicenter, Randomized Controlled Trial", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-04-08", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "sub-lobectomy", "Type": "PROCEDURE", "Description": "Combined with previous research and our team's precise neurosurgery concept, we define the surgical strategy based on lobectomy and further preserving the brain parenchyma in functional areas according to anatomical landmarks and electrophysiological boundaries as sub-lobectomy.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH", "TERT" ], "classes": [] } }, { "Name": "imaging total resection", "Type": "PROCEDURE", "Description": "Imaging total resection (T1-enhanced borders) will met the RANO criteria", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH", "MET", "TERT" ], "classes": [] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH", "MET", "TERT" ], "classes": [] } }, { "NCTId": "NCT01308632", "BriefTitle": "Metronomic Temozolamide in Patients With Recurrent Glioblastoma", "OfficialTitle": "PHASE I-II TRIAL OF METRONOMIC TEMOZOLAMIDE WITH INTERMITTENT INTENSIFICATION AND IRINOTECAN IN PATIENTS WITH RECURRENT GLIOBLASTOMA", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2007-11", "PrimaryCompletionDate": "2012-06", "Interventions": [ { "Name": "Temozolamide, irinotecan", "Type": "DRUG", "Description": "Phase I trial:\n\nTMZ will be administered in a fixed schedule as follows:\n\nTMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28.\n\n100 mg/m2 in a morning single dose on days 8 and 22\n\nCPT-11 starting dose:\n\n100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1)\n\nOne cycle = 28 days\n\nCPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 .", "OtherNames": [ "CPT-11", "Campto", "Irinotecan", "Temozolamide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01564914", "BriefTitle": "A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma", "OfficialTitle": "A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab for the Treatment Of Recurrent or Progressive Glioblastoma That Has Progressed on Bevacizumab", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-05", "PrimaryCompletionDate": "2015-06", "Interventions": [ { "Name": "TRC105", "Type": "DRUG", "Description": "10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle", "OtherNames": [ "carotuximab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "IV", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Tracon Pharmaceuticals Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "The Cleveland Clinic", "Case Comprehensive Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03538587", "BriefTitle": "Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers", "OfficialTitle": "Feasibility and Preliminary Efficacy of an Enhanced Mindfulness Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers: A Pilot Randomized Controlled Trial", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-01-29", "PrimaryCompletionDate": "2022-09-13", "Interventions": [ { "Name": "Enhanced Mindfulness Intervention", "Type": "BEHAVIORAL", "Description": "The 8-week EMI will consist of one initial in-person session with the participant and parent, a series of at home assignments, and two \"booster\" sessions. The psychoeducation group will be given educational material about coping with cancer.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Psychoeducation", "Type": "BEHAVIORAL", "Description": "The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02076152", "BriefTitle": "FMISO PET Study of Glioblastoma", "OfficialTitle": "A Study to Evaluate Vascular Normalization in Patients With Recurrent Glioblastoma Treated With Bevacizumab Using FMISO PET and Vascular MRI", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2019-04", "Interventions": [ { "Name": "FMISO PET", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "MRI", "Type": "DEVICE", "Description": "MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2\\*-weighted perfusion scans, and MR Spectroscopy. The \"Autoalign\" package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.", "OtherNames": [ "Avastin®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "CCNU", "Type": "DRUG", "Description": "A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00946335", "BriefTitle": "ABT-888 and Temozolomide in Treating Young Patients With Recurrent or Refractory CNS Tumors", "OfficialTitle": "A Phase I Study of ABT-888, an Oral Inhibitor of Poly (ADP-Ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-07", "PrimaryCompletionDate": "2011-10", "Interventions": [ { "Name": "veliparib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ABT-888" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01582152", "BriefTitle": "Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma", "OfficialTitle": "Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus TPI 287 in Adults With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-07", "PrimaryCompletionDate": "2016-03", "Interventions": [ { "Name": "TPI287", "Type": "DRUG", "Description": "Phase I Starting Dose: 160 mg/m2 given by vein on Day 1 every three weeks of a 42 Day cycle.\n\nPhase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Arm A + B: 10 mg/kg by vein every 2 weeks of a 42 day cycle.", "OtherNames": [ "Avastin", "Anti-VEGF Monoclonal Antibody", "rhuMAb-VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cortice Biosciences, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04547855", "BriefTitle": "Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen", "OfficialTitle": "A Phase II Study of Anlotinib Combined With Dose-dense Temozolomide for the First Recurrent or Progressive Glioblastoma After STUPP Regimen", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-09-11", "PrimaryCompletionDate": "2022-09-11", "Interventions": [ { "Name": "anlotinib combined with dose-dense temozolomide", "Type": "DRUG", "Description": "Temozolomide Capsule 150mg, p.o., qd, d1-7,15-21,4 weeks one cycle; Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.", "OtherNames": [ "Anlotinib hydrochloride capsule" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Yonggao Mou", "LeadSponsorClass": "OTHER", "Collaborators": [ "The First Affiliated Hospital of Nanchang University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT03529448", "BriefTitle": "TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma", "OfficialTitle": "Phase Ib, Open-label, Multicenter, Intrapatient Dose-escalation Clinical Trial to Assess the Safety Profile of the TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-08-18", "PrimaryCompletionDate": "2025-03", "Interventions": [ { "Name": "TN-TC11G", "Type": "DRUG", "Description": "TN-TC11G dose will be gradually increased as follows:\n\nWeek 1: TN-TC11G: 0-0-5 mg (THC 5 mg + CBD 5 mg; in the mornings, 90 minutes after breakfast; in the afternoons, 90 minutes after lunch; in the evenings, 90 minutes after dinner).\n\nWeek 2: TN-TC11G: 5-0-5 mg Week 3: TN-TC11G: 5-5-5 mg Week 4: TN-TC11G: 5-5-10 mg Week 5: TN-TC11G: 5-5-15 mg Week 6: TN-TC11G: 10-10-15 mg Week 7: TN-TC11G: 10-10-20 mg. Week 8: TN-TC11G: 15-15-30 mg Week 9: TN-TC11G: 20-20-40 mg TN-TC11G will be administered daily at the relevant dose level according to the individual titration performed in the first 9 weeks of treatment. If there is any dose reduction, the reduced dose must be administered.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide Oral Product", "Type": "DRUG", "Description": "During RT, patients will receive Temozolomide (TMZ). All patients will be given TMZ at 75 mg/m2/d concurrently with RT for a maximum of 42 days.\n\nAt 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles.", "OtherNames": [ "Temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "All the patients will receive the Stupp regimen. The radiotherapy (RT) treatment will be administered in fractions of 1.8-2.0 Gy/day delivered 5 days/week to a total dose of 58-60 Gy. Radiotherapy will be delivered to the gross tumor volume with a 2-3 cm margin for the clinical target volume.", "OtherNames": [ "STUPP" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [ "Medical Cannabis Bike Tour", "Voices Against Brain Cancer", "Tilray" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01222221", "BriefTitle": "Vaccine Therapy, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Cancer Research UK Phase I Trial of IMA950 (A Novel Multi-Peptide Vaccine) Plus GM-CSF in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-07", "PrimaryCompletionDate": "2015-02", "Interventions": [ { "Name": "glioblastoma multiforme multipeptide vaccine IMA950", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Cancer Research UK", "LeadSponsorClass": "OTHER", "Collaborators": [ "Immatics Biotechnologies GmbH" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05720078", "BriefTitle": "UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3)", "OfficialTitle": "UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-3 (UNITED-3): Applying a Two Phase, Personalized Margin, Reduced Clinical Target Volume Approach", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-04-01", "PrimaryCompletionDate": "2026-04-30", "Interventions": [ { "Name": "Adaptive, two-phase RT", "Type": "RADIATION", "Description": "Participants in this arm will be treated with an adaptive, two-phase radiation therapy approach", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sunnybrook Health Sciences Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06136611", "BriefTitle": "Preoperative Preradiotherapy TTFields", "OfficialTitle": "Preoperative Preradiotherapy TTFields (PORTRAIT)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-07-31", "PrimaryCompletionDate": "2025-07-01", "Interventions": [ { "Name": "TTFields", "Type": "DEVICE", "Description": "TTFields will be delivered through 4 transducer arrays with 9 insulated electrodes each placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The Christie NHS Foundation Trust", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Manchester", "Northern Care Alliance NHS Foundation Trust", "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00313521", "BriefTitle": "Thiotepa and Radiation Therapy in Treating Young Patients With Newly Diagnosed Malignant Brain Tumors", "OfficialTitle": "Continuous Infusion Thiotepa in High Grade Astrocytic Tumors of Childhood and Adolescence A UKCCSG Phase II Study Involving the Brain Tumour and New Agent Groups", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "1995-06", "PrimaryCompletionDate": "1997-11", "Interventions": [ { "Name": "thiotepa", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Cancer and Leukaemia Group", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01867593", "BriefTitle": "MET-PET for Newly Diagnosed Glioblastoma", "OfficialTitle": "Pilot Study of MET-PET (L-[Methyl]-11C Methionine Positron Emission Tomography) to Evaluate for Treatment Response After Chemoradiation Therapy for Newly-diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "C-11 methionine PET", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01975116", "BriefTitle": "p28 in Treating Younger Patients With Recurrent or Progressive Central Nervous System Tumors", "OfficialTitle": "A Phase I Trial of p28 (NSC745104), a Non-HDM2 Mediated Peptide Inhibitor of p53 Ubiquitination in Pediatric Patients With Recurrent or Progressive CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-08", "PrimaryCompletionDate": "2015-04", "Interventions": [ { "Name": "azurin-derived cell-penetrating peptide p28", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "azurin-derived CPP p28" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03866109", "BriefTitle": "A Study Evaluating Temferon in Patients with Glioblastoma & Unmethylated MGMT", "OfficialTitle": "A Phase I/IIa Dose Escalation Study Evaluating the Safety and Efficacy of Autologous CD34+-enriched HSPCs Genetically Modified with Human Interferon-α2 in Patients with Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-03-05", "PrimaryCompletionDate": "2025-12-09", "Interventions": [ { "Name": "Temferon", "Type": "DRUG", "Description": "Genetically modified HSPCs", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Genenta Science", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT00509821", "BriefTitle": "Enzastaurin Before and Concomitant With Radiation, Followed by Enzastaurin in Participants With Newly Diagnosed Glioblastoma", "OfficialTitle": "Enzastaurin Before and Concomitant With Radiation Therapy, Followed by Enzastaurin Maintenance Therapy in Patients With Newly Diagnosed Glioblastoma Without Methylation of the Promoter Gene of MGMT Enzyme - a Phase II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "Enzastaurin 500 milligram (mg) Once Daily (QD)", "Type": "DRUG", "Description": "1125 mg loading dose D(-)7 then 500 mg QD, oral, daily until disease progression, given with and without radiotherapy treatment.", "OtherNames": [ "LY317615" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Enzastaurin 250 mg Twice Daily (BID)", "Type": "DRUG", "Description": "1125 mg loading dose D(-)7 then 250 mg BID, oral, daily until disease progression, given with and without radiotherapy treatment.", "OtherNames": [ "LY317615" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT04094610", "BriefTitle": "A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations", "OfficialTitle": "A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-03-12", "PrimaryCompletionDate": "2026-09-30", "Interventions": [ { "Name": "Oral repotrectinib (TPX-0005)", "Type": "DRUG", "Description": "Oral repotrectinib (TPX-0005)", "OtherNames": [ "Oral repotrectinib (TPX-0005) capsules", "Oral repotrectinib (TPX-0005) oral suspension", "repotrectinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Turning Point Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT05399524", "BriefTitle": "Functional and Ultrasound Guided Resection of Glioblastoma", "OfficialTitle": "FUTURE-GB Trial (Functional and Ultrasound-guided Resection of Glioblastoma) A 2-Stage Trial. A Learning Phase Evaluation of Participating Centres, Followed by a Randomised, Controlled Multicentre Phase III Trial.", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2020-11-01", "PrimaryCompletionDate": "2025-10", "Interventions": [ { "Name": "Standard of Care", "Type": "OTHER", "Description": "Neuronavigation and intraoperative 5-ALA", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Additional pre- and intra-operative imaging", "Type": "OTHER", "Description": "Additional DTI scan during routine pre-operative tumour MRI scan, additional use of intraoperative ultrasound in addition to normal to standard of care (Neuronavigation and intraoperative 5-ALA)", "OtherNames": [ "DTI", "IUS" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Oxford", "LeadSponsorClass": "OTHER", "Collaborators": [ "Imperial College Healthcare NHS Trust", "Efficacy and Mechanism Evaluation (EME) Programme" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01209442", "BriefTitle": "Hypofractionated Intensity-Modulated Radiation Therapy With Temozolomide and Bevacizumab for Glioblastoma Multiforme", "OfficialTitle": "A Pilot Phase II Trial of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) and Bevacizumab for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-09-16", "PrimaryCompletionDate": "2014-09-07", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, patients will receive 6 cycles of Bevacizumab.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily temozolomide at 75 mg/m2 qd concurrent with IMRT. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, temozolomide will be given at 150-200 mg/m2 qd on days 1-5 of each cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "RT (Radiation Therapy)", "Type": "RADIATION", "Description": "Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx)", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Colorado, Denver", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04977375", "BriefTitle": "Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-12-09", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Stereotactic Radiation Therapy", "Type": "RADIATION", "Description": "Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Surgical Resection", "Type": "PROCEDURE", "Description": "Standard of care surgical resection of tumor on Day 10-28", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Chirag G. Patil", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00458601", "BriefTitle": "Phase II Study of Rindopepimut (CDX-110) in Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study of CDX-110 With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-08", "PrimaryCompletionDate": "2010-11", "Interventions": [ { "Name": "CDX-110 with GM-CSF", "Type": "DRUG", "Description": "Three biweekly intradermal injections over four weeks followed by monthly injections until tumor progression. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.", "OtherNames": [ "CDX-110 with sargramostim (GM-CSF) (Leukine®)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Maintenance temozolomide will begin after completion of the three initial injections of CDX-110 plus GM-CSF. 150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, intolerance or progression.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Celldex Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00387400", "BriefTitle": "Temozolomide + Everolimus in Newly Diagnosed, Recurrent, or Progressive Malignant Glioblastoma Multiforme", "OfficialTitle": "A Phase I Study of Temozolomide and RAD001C in Patients With Malignant Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-03-20", "PrimaryCompletionDate": "2010-09-24", "Interventions": [ { "Name": "everolimus", "Type": "DRUG", "Description": "150 mg/m2/day PO Daily x 5, q 4 weeks", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "2.5 mg PO Daily, beginning day 2 of cycle 1, q 4 weeks", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "microarray analysis", "Type": "GENETIC", "Description": "Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR", "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "immunohistochemistry staining method", "Type": "OTHER", "Description": "Tissue sections will be stained by immunohisto-chemistry using the following antibodies: EGFRvIII, PTEN, phospho-specific PKB/Akt Ser473; phosphor-mTORSer2448, p70S6K Thr389; S6 ribosomal protein Ser235/236. These antibodies are selected on the basis of providing a readout of upstream and downstream signaling through mTOR, and availability of antibodies that reliably stain paraffinembedded tissue.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET", "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NCIC Clinical Trials Group", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "MET", "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00041587", "BriefTitle": "Pre-operative IL13-PE38QQR in Patients With Recurrent or Progressive Malignant Glioma", "OfficialTitle": "Pre-operative IL13-PE38QQR Infusion in Patients With Recurrent or Progressive Supratentorial Malignant Glioma: A Phase I/II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-07", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "IL13-PE38QQR", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "targeted fusion protein therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02858895", "BriefTitle": "Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma", "OfficialTitle": "An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-04-11", "PrimaryCompletionDate": "2019-09-12", "Interventions": [ { "Name": "MDNA55", "Type": "DRUG", "Description": "MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).", "OtherNames": [ "IL4-PE", "Interleukin-4 Pseudomonas Exotoxin", "Interleukin-4 Pseudomonas Toxin", "IL4 Pseudomonas Exotoxin", "NBI-3001", "cpIL4-PE" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medicenna Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04545177", "BriefTitle": "Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue", "OfficialTitle": "Prospective Surgical Study on the Feasibility of Semi-Automated Tissue Collection, Stabilization, Preservation, and Site Transfer - Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-09-17", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "NICO Myriad and Tissue Preservation System (TPS)", "Type": "DEVICE", "Description": "Tumor tissue will be obtained by the NICO Myriad and Tissue Preservation System (TPS) via an automated, standardized methodology", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03389230", "BriefTitle": "Memory-Enriched T Cells in Treating Patients With Recurrent or Refractory Grade III-IV Glioma", "OfficialTitle": "Phase I Study of Cellular Immunotherapy Using Memory-Enriched T Cells Lentivirally Transduced to Express a HER2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-08-14", "PrimaryCompletionDate": "2026-01-12", "Interventions": [ { "Name": "HER2(EQ)BBζ/CD19t+ T cells", "Type": "BIOLOGICAL", "Description": "Given via catheter", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Leukapheresis", "Type": "PROCEDURE", "Description": "Undergo leukapheresis", "OtherNames": [ "Leukocytopheresis", "Therapeutic Leukopheresis" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01854099", "BriefTitle": "Peptide Vaccine for Glioblastoma Against Cytomegalovirus Antigens", "OfficialTitle": "Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2014-01", "Interventions": [ { "Name": "PEP-CMV", "Type": "BIOLOGICAL", "Description": "500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m\\^2 x 5 days) with group 1.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "PEP-CMV", "Type": "BIOLOGICAL", "Description": "500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m\\^2 x 5 days) with group 2.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "PEP-CMV", "Type": "BIOLOGICAL", "Description": "500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m\\^2 x 21 days) with group 3.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "American Brain Tumor Association" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02507102", "BriefTitle": "A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia", "OfficialTitle": "A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM) in Australia", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2015-08", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Voyager", "Type": "DEVICE", "Description": "Non-invasive RFE therapy", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Nativis, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03355794", "BriefTitle": "A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)", "OfficialTitle": "A Phase I Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-11-14", "PrimaryCompletionDate": "2020-07-31", "Interventions": [ { "Name": "ribociclib", "Type": "DRUG", "Description": "Oral capsule or liquid formula", "OtherNames": [ "Kisqali" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "Oral tablets or dispersible tablets", "OtherNames": [ "Afinitor" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "Children's Hospital Medical Center, Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT00921167", "BriefTitle": "A Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Gliomas", "OfficialTitle": "A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2012-06", "Interventions": [ { "Name": "Bevacizumab/Irinotecan", "Type": "DRUG", "Description": "Bevacizumab 10mg/kg D1 Irinotecan 125mg/m2 D1 (without enzyme-inducing antiepileptic drugs \\[EIAEDs\\] or 340mg/m2 for patients on EIAEDs) every 2 weeks", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Clinical Research Center for Solid Tumor, Korea", "LeadSponsorClass": "OTHER", "Collaborators": [ "Seoul National University Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03454295", "BriefTitle": "Easing Psychosocial Burden for Informal Caregivers", "OfficialTitle": "Improving Palliative Care of Caregivers of Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2018-02-12", "PrimaryCompletionDate": "2024-03-26", "Interventions": [ { "Name": "Focus Group", "Type": "BEHAVIORAL", "Description": "Participants will be asked to reflect on their caregiving experience and specifically, when the receipt of a supportive intervention that addresses existential distress would have been most appropriate and well received.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C", "Type": "BEHAVIORAL", "Description": "MCP-C is structured as a 7-session (1-hour weekly or biweekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and cancer caregiving", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Enhanced Usual Care / EUC", "Type": "BEHAVIORAL", "Description": "The \"enhancement\" to usual care in this study involves the inclusion of screening and targeted referral components as suggested by Reynolds et al. \\[79\\]. Research study assistants conducting the screening and providing feedback and referrals will be trained in the NCCN guidelines for distress management and will discuss the screening results and associated recommendations with the study PI (NCCN) \\[63\\]. As of November, 2017, ICs of patients seen in the Neurology Service at MSKCC are not consistently screened for distress and offered targeted referrals. Participants randomized to EUC will receive feedback about their level of distress (based on the Distress Thermometer administered at screening) after randomization. Within a week of randomization, and post-baseline, the study RSA will send EUC participants appropriate targeted referrals based on levels of distress and problem areas endorsed.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT07100730", "BriefTitle": "Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma", "OfficialTitle": "A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-11-02", "PrimaryCompletionDate": "2027-07", "Interventions": [ { "Name": "TLX-101-Tx + Lomustine", "Type": "COMBINATION_PRODUCT", "Description": "Combination therapy with TLX-101-Tx + Lomustine", "OtherNames": [ "131I-IPA", "131I-TLX101" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TLX101-Tx", "Type": "RADIATION", "Description": "TLX101-Tx", "OtherNames": [ "131I-IPA", "131I-TLX101" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Telix Pharmaceuticals (Innovations) Pty Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04573192", "BriefTitle": "A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression", "OfficialTitle": "A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-02-19", "PrimaryCompletionDate": "2025-03", "Interventions": [ { "Name": "L19TNF", "Type": "DRUG", "Description": "Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine", "OtherNames": [ "onfekafusp alfa" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Philogen S.p.A.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01805453", "BriefTitle": "Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma", "OfficialTitle": "Angiotensin II Receptor Blockers, Steroids and Radiotherapy in Glioblastoma- A Randomized Multicenter Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2013-03-29", "PrimaryCompletionDate": "2015-01-15", "Interventions": [ { "Name": "Losartan", "Type": "DRUG", "Description": "Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan or placebo (Arm A or B) 50mg\\*2/day until the halting for any reason", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [ "ANOCEF (french association of neuro-oncologists)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03244995", "BriefTitle": "Mind-Body Intervention in Glioma Couples", "OfficialTitle": "An Online Dyadic Mind-Body Intervention for Glioma Patients and Their Partners", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2017-08-06", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Mind-Body Intervention Procedure", "Type": "PROCEDURE", "Description": "Undergo CBMB program", "OtherNames": [ "Mind-Body Interventions", "Mind-Body Medicine" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03149575", "BriefTitle": "VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM", "OfficialTitle": "A Pivotal Randomized, Controlled Trial of VAL-083 in Patients With Recurrent Glioblastoma Who Have Failed Standard Temozolomide/Radiation Therapy and Bevacizumab (STAR-3)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2017-10-27", "PrimaryCompletionDate": "2019-05-31", "Interventions": [ { "Name": "VAL-083, Dianhydrogalactitol", "Type": "DRUG", "Description": "VAL-083 given by intravenous infusion at a dose 40 mg/m2 IV on days 1, 2, and 3 of a 21-day treatment-cycle, for up to 12, 21-day treatment cycles", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Physician's Choice of Salvage Therapy - temozolomide", "Type": "DRUG", "Description": "The product label for temozolomide (Temodar®) provides the following dosing information.\n\nNewly Diagnosed GBM: 75 mg/m2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for Days 1-5 of a 28-day cycle of Temodar® for 6 cycles.\n\nRefractory Anaplastic Astrocytoma: Initial dose 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Physician's Choice of Salvage Therapy - lomustine", "Type": "DRUG", "Description": "The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.\n\nThe recommended dose of lomustine in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/m2 as a single oral dose every 6 weeks In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/m2 every 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Physician's Choice of Salvage Therapy - carboplatin", "Type": "DRUG", "Description": "The product label for (Paraplatin) carboplatin Injection provides the following dosing information.\n\nAs a single agent at a dosage of 360mg/m2 IV on day 1 every 28 days Alternatively, the carboplatin dose may be calculated by the Calvert formula below Calvert formula for carboplatin dosing: Total Dose (mg) = (target AUC) x (GFR + 25), where AUC = area under the curve and GFR = glomerular filtration rate.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "DelMar Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01020292", "BriefTitle": "A Trial of the Protease Inhibitor Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma", "OfficialTitle": "Nelfinavir and Concurrent Radiation and Temozolomide in Patients With WHO Grade IV Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-04", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Nelfinavir", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01346267", "BriefTitle": "Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy", "OfficialTitle": "Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2011-05", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "Real Acupressure Band", "Type": "PROCEDURE", "Description": "Acupressure wristband", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Placebo Acupressure Band", "Type": "PROCEDURE", "Description": "Sham wristband", "OtherNames": [ "sham intervention" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University of South Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00250211", "BriefTitle": "Magnetic Resonance Spectroscopic Imaging (MRS) and Tumor Perfusion of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide", "OfficialTitle": "Multimodality Functional Imaging (MRS and Tumor Perfusion) Predicts Tumor Migration, Invasiveness, and Patterns of Failure of Human Glioblastoma Treated With Concurrent Radiation Therapy and Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-03", "PrimaryCompletionDate": "2011-03", "Interventions": [ { "Name": "Functional MRI imaging and tomotherapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cross Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01903330", "BriefTitle": "ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme", "OfficialTitle": "A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma Patients (WHO Grade IV Malignant Gliomas, GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2014-03", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "ERC1671", "Type": "DRUG", "Description": "Given intradermally", "OtherNames": [ "Gliovac" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "GM-CSF", "Type": "DRUG", "Description": "Given intradermally", "OtherNames": [ "Leukine®", "sargramostim" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Given PO. Drug class: Alkylating Agent; Antineoplastic Agent; Nitrogen Mustard.", "OtherNames": [ "2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "ALK", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Oral Control (Sucrose pill)", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%))", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab/Bevacizumab Biosimilar", "Type": "DRUG", "Description": "Given IV. Drug class: Immunological Agent; Monoclonal Antibody.", "OtherNames": [ "Avastin", "MVASI", "bevacizumab-awwb", "bevacizumab-bvzr", "ZIRABEV" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Epitopoietic Research Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University of California, Irvine" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05685004", "BriefTitle": "Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)", "OfficialTitle": "Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2023-09-15", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "TVI-Brain-1", "Type": "BIOLOGICAL", "Description": "Attenuated autologous cancer cells and activated autologous blood-derived t cells", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard of Care", "Type": "PROCEDURE", "Description": "Surgery for tumor removal or debulking to minimize tumor burden", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Conformal radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "All Subjects receive 75 mg/m2 of temozolomide daily beginning on the first day of radiotherapy and continuing until the completion of radiotherapy. Standard of care Subjects will also receive adjuvant temozolomide .", "OtherNames": [ "Chemotherapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "TVAX Biomedical", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06524063", "BriefTitle": "Targeted Survivin DC Cell Injection for the Treatment of GBM", "OfficialTitle": "Phase I Clinical Study of Targeted Survivin DC Cell Injection for the Treatment of Newly Diagnosed Primary Glioblastoma Multiforme (GBM)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-08-01", "PrimaryCompletionDate": "2025-12-01", "Interventions": [ { "Name": "Survivin-loaded dendritic cell injection", "Type": "DRUG", "Description": "The injections will be given on days 0, 14, and 28. The administration will involve both intradermal (ID) and intravenous (IV) routes.", "OtherNames": [ "Targeted Survivin DC cell therapy" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tricision Biotherapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00977431", "BriefTitle": "Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform", "OfficialTitle": "Phase I, Open Label Trial to Explore Safety of Combining BIBW 2992 and Radiotherapy With or Without Temozolomide in Newly Diagnosed GBM", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-09-17", "PrimaryCompletionDate": "2017-09-12", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "During RT: 75 mg/m2 daily , 4 weeks after RT: given days 1 to 5 of 28 day cycles (150 mg/m2 in cycle 1, 200 mg/m2 in cycle 2 up to cycle 6)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiotherapy", "Type": "PROCEDURE", "Description": "Day 1 to day 42", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "BIBW2992", "Type": "DRUG", "Description": "Escalating dose cohorts during Radiotherapy(RT) period, fixed dose after RT", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Radiotherapy", "Type": "PROCEDURE", "Description": "Day 1 to day 42", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "BIBW2992", "Type": "DRUG", "Description": "Escalating dose cohorts during Radiotherapy(RT) period , fixed dose after RT", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Boehringer Ingelheim", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT02977780", "BriefTitle": "INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)", "OfficialTitle": "INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2017-02-09", "PrimaryCompletionDate": "2028-02-01", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temzolomide capsules", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Neratinib", "Type": "DRUG", "Description": "Neratinib tablets", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "QBS10072S", "Type": "DRUG", "Description": "QBS10072S administered intravenously", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Abemaciclib", "Type": "DRUG", "Description": "Abemaciclib tablets", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "CC-115", "Type": "DRUG", "Description": "CC-115 tablets", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Patrick Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Eli Lilly and Company", "Celgene", "Puma Biotechnology, Inc.", "Accelerate Brain Cancer Cure", "Quadriga Biosciences, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [ "CDK" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT00683761", "BriefTitle": "A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-08", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "131I-TM601", "Type": "DRUG", "Description": "In the first study phase (Dose Escalation), patients will be assigned to treatment to between 2-5 doses of 131I-TM601 treatment at a treatment dose of 1.2 mCi/kg of lean body mass (in scaled dosing, this will amount to 0.024 mg TM601 peptide/kg of lean body mass), once weekly (for between 2-5 weeks, depending upon dose cohort). The maximum amount of administered radioactivity per infusion is 100 mCi.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "TransMolecular", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01837862", "BriefTitle": "A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas", "OfficialTitle": "A Phase I Study of Mebendazole for the Treatment of Pediatric Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-10-22", "PrimaryCompletionDate": "2024-04", "Interventions": [ { "Name": "Mebendazole", "Type": "DRUG", "Description": "Mebendazole will be given orally twice daily for over the course of treatment (70 weeks for low-grade glioma patients, 48 weeks for high-grade glioma/pontine glioma patients). Mebendazole will be prescribed according to the particular dose cohort for each patient (50 mg/kg/day, 100 mg/kg/day, or 200 mg/kg/day).", "OtherNames": [ "Vermox" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Vincristine", "Type": "DRUG", "Description": "Low-grade glioma patients only. Vincristine will be dosed as per the following: For patients \\< 12kg: 0.05 mg/kg; for patient \\> 12kg: 1.5mg/m2 (maximal dose 2.0 mg). Vincristine will be administered intravenously on Day 1 of weeks 0,1,2,3,4,5 during the 10-week induction cycle and on Day 1 of Weeks 0,1,2 of the six 10-week maintenance cycles.", "OtherNames": [ "Oncovin" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Low-grade glioma patients only. Carboplatin will be dosed at 175 mg/m2. Carboplatin will be administered intravenously on Day 1 of Weeks 0,1,2,3 of the 10-week Induction cycle, and on Day 1 of Weeks 0,1,2,3 during the six 10-week maintenance cycles.", "OtherNames": [ "Paraplatin" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Low-grade glioma patients only. Temozolomide will be dosed at 200 mg/m2/day. Temozolomide will be given orally for 5 days during Week 6 of the 10-week induction cycle and for 5 days during Week 6 of the six 10-week maintenance cycles.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "High-grade glioma/pontine glioma patients only. Bevacizumab will be dosed at 10mg/kg/dose. Bevacizumab will be administered intravenously on Days 1 and 15 of each maintenance cycle.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "High-grade glioma/pontine glioma patients only. Irinotecan will be administered at doses 125 mg/m2, 150 mg/m2, 250 mg/m2, or 300 mg/m2, depending on patient tolerance and concomitant enzyme-inducing anti-epileptic medication use. Irinotecan will be administered intravenously on Days 1 and 15 of each maintenance cycle.", "OtherNames": [ "CPT-11", "Camptosar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Julie Krystal", "LeadSponsorClass": "OTHER", "Collaborators": [ "Janssen Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04019262", "BriefTitle": "Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma: Comparison of Two Established Schedules", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-12-14", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Radiation", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide Oral Product", "Type": "DRUG", "Description": "Oral Temozolomide (150mg/m\\^2 or 75 mg/m\\^2)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "John Flickinger", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01257594", "BriefTitle": "EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas", "OfficialTitle": "Pilot Study of EGFR Inhibition Using High Dose Administration of Erlotinib Weekly for Recurrent Malignant Gliomas With EGFR Variant III Mutation", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-01-07", "PrimaryCompletionDate": "2016-11-22", "Interventions": [ { "Name": "erlotinib", "Type": "DRUG", "Description": "For patients with no cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg on days 1 of every 7 days. For patients with cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg day 1 of every 7 days (+/- 2 days). One pre-operative dose of 2000 mg erlotinib will be administered in an open-label, unblinded manner, administered in the hospital \"on call\" to the operating room.", "OtherNames": [ "Tarceva" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Cytoreductive Surgery", "Type": "PROCEDURE", "Description": "Standard procedure", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Andrew B Lassman, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "OSI Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03951142", "BriefTitle": "Imaging Perfusion Restrictions From Extracellular Solid Stress - An Open-label Losartan Study", "OfficialTitle": "Imaging Perfusion Restrictions From Extracellular Solid Stress - An Open-label Losartan Study", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2019-10-01", "PrimaryCompletionDate": "2024-10-01", "Interventions": [ { "Name": "Losartan", "Type": "DRUG", "Description": "This trial is open-label; therefore, the participant, the trial site personnel, the Sponsor and/or designee are not blinded to treatment. Drug identity (name, strength) is included in the label text. Storage, handling and preparation requirements will be handled in concordance with the Pharmacy Manual for losartan.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Kyrre Eeg Emblem", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01268566", "BriefTitle": "A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-01", "PrimaryCompletionDate": "2012-11", "Interventions": [ { "Name": "MEDI-575", "Type": "DRUG", "Description": "MEDI-575 as an IV infusion.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "MedImmune LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03514069", "BriefTitle": "Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma", "OfficialTitle": "Phase I Study of Ruxolitinib With Radiation and Temozolomide in Patients With Newly Diagnosed Grade III Gliomas and Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-06-05", "PrimaryCompletionDate": "2021-08-27", "Interventions": [ { "Name": "ruxolitinib", "Type": "DRUG", "Description": "Starting dose ruxolitinib 10 mg twice daily", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "radiation", "Type": "RADIATION", "Description": "60gy for 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "75mg/m2", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00401024", "BriefTitle": "Tumor Tissue Analysis in Patients Receiving Imatinib Mesylate for Malignant Glioma", "OfficialTitle": "Determination of the In-Tumor-Concentration of Imatinib Mesylate in Malignant Glioma After Oral Administration", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-10-12", "PrimaryCompletionDate": "2008-02-04", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00002572", "BriefTitle": "Cytotoxic T Cells and Interleukin-2 in Treating Adult Patients With Recurrent Brain Tumors", "OfficialTitle": "Intracavitary Allogenic Cytotoxic T Lymphocytes and Human Recombinant Interleukin-2 Therapy for Recurrent Primary Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1994-11", "PrimaryCompletionDate": "1999-12", "Interventions": [ { "Name": "aldesleukin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "muromonab-CD3", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic tumor infiltrating lymphocytes", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Colorado, Denver", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00238277", "BriefTitle": "Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2005-02-15", "PrimaryCompletionDate": "2007-12-11", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "chemotherapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03778294", "BriefTitle": "18F-DOPA-PET/MRI Scan in Imaging Elderly Patients With Newly Diagnosed Grade IV Malignant Glioma or Glioblastoma During Planning for a Short Course of Proton Beam Radiation Therapy", "OfficialTitle": "Phase II Study of Short Course Hypofractionated Proton Beam Therapy Incorporating 18F-DOPA-PET/MRI for Elderly Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2019-03-28", "PrimaryCompletionDate": "2022-06-30", "Interventions": [ { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT", "OtherNames": [ "CAT", "CAT Scan", "Computerized Axial Tomography", "Computerized Tomography", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Fluorodopa F 18", "Type": "OTHER", "Description": "Given IV", "OtherNames": [ "(18F)FDOPA", "18F-DOPA", "18F-FDOPA", "3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine", "6-(18F)Fluoro-L-DOPA", "Fluorine F 18 Fluorodopa", "Fluorine-18-fluoro-L-DOPA", "Fluorodopa (18F)", "FLUORODOPA F-18", "L-6-(18F)Fluoro-DOPA" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo PET/MRI", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT or PET/MRI", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Proton Beam Radiation Therapy", "Type": "RADIATION", "Description": "Receive proton beam RT", "OtherNames": [ "PBRT", "Proton", "Proton Radiation Therapy", "Radiation, Proton Beam" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Drug", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01526837", "BriefTitle": "Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence", "OfficialTitle": "A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2011-10", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "Avastin", "Type": "DRUG", "Description": "Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Brain & Spine Surgeons of New York", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT07211841", "BriefTitle": "Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)", "OfficialTitle": "Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-12", "PrimaryCompletionDate": "2027-04", "Interventions": [ { "Name": "MRS study", "Type": "DEVICE", "Description": "Thirty patients newly diagnosed with GBM will be included in this study. The study will be conducted without any major modification of the standard management of GBM.\n\nThe MRS study will be performed at the time of the initial MRI examination (morphological MRI sequences performed on 3T Philipps). The MRS will be performed on the most agressive part of the tumor : monovoxel PRESS MRS sequence with 3 echo times : 35, 144 and 288 ms. Spectra processing with Philipps software returns relative quantifications \\> 7 ratios (choline/creatin, Glucose/creatin, glutamine/creatin, N-Acetyl aspartate/creatin, myoinositol/creatin, phsopholipids/creatin, lactate/creatin, acetate/creatin). With this experimental design, the additional time required for MRS acquisition is 10 min /patient.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "blood samples", "Type": "BIOLOGICAL", "Description": "Routine basic clinical and biological analyses will be collected during the project. In addition, 2 blood samples (5 mL each time) will be obtained at the time of inclusion (pre-therapeutic) and one month after completion of the initial therapeutic cycle (surgery + radiochemotherapy). The plasma samples will be used to measure fibrinogen, lactate and choline concentrations. In addition, a metabolomic study of plasma will be performed w", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire, Amiens", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04195139", "BriefTitle": "Nivolumab and Temozolomide Versus Temozolomide Alone in Newly Diagnosed Elderly Patients With GBM", "OfficialTitle": "A Randomised Phase II Study of NivolUmab and TeMozolomide vs Temozolomide Alone in Newly Diagnosed Elderly Patients With Glioblastoma (NUTMEG)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-02-22", "PrimaryCompletionDate": "2024-06-28", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Participants will receive Nivolumab intravenous infusions (240 mg days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6).", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Participants will receive temozolomide (TMZ) tablets days 1-5, every 28 days for 6 cycles. TMZ will be dosed at 150mg/m2 for the first cycle. If well tolerated TMZ is then given at 200mg/m2 for cycles 2 - 6.", "OtherNames": [ "Temodar", "Temodal", "Temcad" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Sydney", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cooperative Trials Group for Neuro-Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02794883", "BriefTitle": "Tremelimumab and Durvalumab in Combination or Alone in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase II, Open Label, Clinical Trial Of Pre-Surgical and Adjuvant Treatment of Recurrent Malignant Glioma With Tremelimumab and Durvalumab (MEDI4736) Alone and in Combination to Determine Immunologic Changes From Treatment", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-11-01", "PrimaryCompletionDate": "2018-05-09", "Interventions": [ { "Name": "Durvalumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer", "MEDI-4736", "MEDI4736" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-L1" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative Studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-L1" ], "classes": [] } }, { "Name": "Surgical Procedure", "Type": "PROCEDURE", "Description": "Undergo surgical tumor resection", "OtherNames": [ "Operation", "Surgery", "Surgical", "Surgical Interventions", "Surgical Procedures" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-L1" ], "classes": [] } }, { "Name": "Tremelimumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-CTLA4 Human Monoclonal Antibody CP-675,206", "CP-675", "CP-675,206", "CP-675206", "Ticilimumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca", "MedImmune LLC", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "PD-L1" ], "classes": [] } }, { "NCTId": "NCT07144735", "BriefTitle": "Allogeneic γδT Cells in Glioblastoma", "OfficialTitle": "Allogeneic Gamma Delta (γδ) T Cells for the Treatment of Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-04-01", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "Allogeneic γδ T (ABOUT) cells", "Type": "DRUG", "Description": "Allogeneic γδ T cells genetically edited to knockout the ARIH1 and BCL11b genes.", "OtherNames": [ "ARIH1 and BCL11b knockout γδ T cells", "ARIH1KO/BCL11bKO γδ T cells" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Peking University Third Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Peking University", "Changping Laboratory" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03868943", "BriefTitle": "Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma", "OfficialTitle": "Open Label Safety Study of Solriamfetol to Promote Wakefulness and Improve Cognition and Quality of Life in Patients With Primary Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2021-01-27", "PrimaryCompletionDate": "2021-11-22", "Interventions": [ { "Name": "Soliramfetol", "Type": "DRUG", "Description": "Solriamfetol will be dosed by flexible dose titration starting at 75 mg daily in all patients and escalating after 7 days (1 week) to 150 mg daily and then after 7 days to 300 mg daily for a total duration of 3 weeks (flexible dose titration period).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00314925", "BriefTitle": "Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features", "OfficialTitle": "Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2006-04", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "Seneca Valley Virus (biological agent)", "Type": "DRUG", "Description": "Dose escalation (starting at 1 × 10\\^7 vp/kg), IV (in the vein) over 1 hour in a single administration", "OtherNames": [ "SVV-001" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Neotropix", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04590664", "BriefTitle": "Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma", "OfficialTitle": "A Phase 1 / 2 Study of Visudyne (Liposomal Verteporfin) in Persons with Recurrent High Grade EGFR-Mutated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-01-15", "PrimaryCompletionDate": "2025-08-15", "Interventions": [ { "Name": "Verteporfin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Benzoporphyrin Derivative Monoacid Ring A", "BPD-MA", "Visudyne" ], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT06017063", "BriefTitle": "Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields", "OfficialTitle": "Coaching for Coping in Glioblastoma Patients and Caregivers and Its Association With Compliance to TTFields", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-10", "PrimaryCompletionDate": "2026-04", "Interventions": [ { "Name": "Psychological intervention", "Type": "OTHER", "Description": "The intervention will include a psychological intervention with counseling sessions (online/video intervention) and telephone follow-up additionally to the care as usual.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Hospital Tuebingen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00734526", "BriefTitle": "Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma", "OfficialTitle": "A Phase I Study of Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2008-12-18", "PrimaryCompletionDate": "2012-12", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Groups 1 \\& 2: 75 mg/m\\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m\\^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m\\^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles.\n\nGroups 3 \\& 4: 75 mg/m\\^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m\\^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Total of 60 Gy delivered over 30 Days (approximately 6 weeks).", "OtherNames": [ "Radiotherapy", "XRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Sorafenib", "Type": "DRUG", "Description": "Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.\n\nGroup 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.\n\nGroup 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth.\n\nGroup 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.", "OtherNames": [ "BAY43-9006" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bayer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06102525", "BriefTitle": "A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 With Valganciclovir (VGCV) in Subjects With Glioblastoma", "OfficialTitle": "A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination With Valganciclovir in Subjects With Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-10-08", "PrimaryCompletionDate": "2029-03", "Interventions": [ { "Name": "RZ-001", "Type": "DRUG", "Description": "Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene", "OtherNames": [ "Ad-ECRT-122T" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "VGCV", "Type": "COMBINATION_PRODUCT", "Description": "VGCV, used in a subject after RZ-001 administration, is a nucleoside analog that is metabolized by HSV-tk and other cellular kinases to form the cytotoxic nucleotide analog ganciclovir triphosphate. An approved oral VGCV will be used in the proposed clinical study of RZ-001.", "OtherNames": [ "Valganciclovir" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Rznomics, Inc.", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00540176", "BriefTitle": "The Safety and Efficacy of DCA for the Treatment of Brain Cancer", "OfficialTitle": "A Phase II Open-labeled, Double-arm Clinical Study of Dichloroacetate (DCA) in Malignant Gliomas and Glioblastome Multiforme (GBM) Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2009-08", "Interventions": [ { "Name": "Dichloroacetate (DCA)", "Type": "DRUG", "Description": "Oral DCA given twice daily for the 24 week period of the study. Continuation of therapy will be indefinite if efficacious.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [ "Capital Health, Canada" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04267978", "BriefTitle": "Study of Recombinant Human Endostatin Combined with Temozolomide and Irinotecan in Recurrent Gliomas", "OfficialTitle": "Open-label Prospective Study of Recombinant Human Endostatin Combined with Cytotoxic Chemotherapy Regimen in the Treatment of Recurrent Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-02-13", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "recombinant human endostatin,temozolomide,irinotecan", "Type": "DRUG", "Description": "Temozolomide was given orally 200mg/m2 for 5 days in each cycle. Day 1 TMZ was administered 3-6 hours prior to irinotecan.\n\nIrinotecan was administrated 125mg/m2 on day 1 and day 15. Recombinant human endostatin was administrated 15mg/d, daily for 14 days. One treatment cycle was defined as 28 days (4 weeks), even if treatment is held mid-cycle for toxicity.\n\nTreatment was continued until disease progression, patient withdrawal, or unacceptable toxicity.\n\nThe maximum number of treatment cycles was 12. After 12 cycles of treatment, if the investigator judges that the subject may continue to benefit from the regimen, the duration of treatment may be extended with the subject's consent.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Beijing Sanbo Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06749925", "BriefTitle": "Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma", "OfficialTitle": "Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Efficacy and Safety of Dendritic Cell-Based Immunotherapy for Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2026-01", "PrimaryCompletionDate": "2028-01", "Interventions": [ { "Name": "Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "This intervention distinguishes itself from others by utilizing allogeneic dendritic cells derived from healthy donors fused with autologous tumor cells from patients, which is a novel approach compared to the commonly used autologous DC-based vaccines (DCVax).", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "COMBINATION_PRODUCT", "Description": "Recent findings have shown that the anti-PD1 monoclonal antibody, a checkpoint inhibitor, can sustainably enhance the anti-tumor immune response. In this study, all patients in the intervention group (vaccine) who reach the fifth dose will be randomized to receive either pembrolizumab or a placebo as an addition to the experimental treatment regimen.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "In this study, all patients in the intervention group (vaccine) who reach the fifth dose will be randomized to receive either pembrolizumab or a placebo as an addition to the experimental treatment regimen.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University of Sao Paulo General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT02617589", "BriefTitle": "An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)", "OfficialTitle": "A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2016-03-01", "PrimaryCompletionDate": "2019-01-17", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bristol-Myers Squibb", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Ono Pharmaceutical Co. Ltd" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06883747", "BriefTitle": "Clinical Trial of BMS-986504 in Recurrent GBM Patients", "OfficialTitle": "A Phase 0/1 Study of BMS-986504, a MTA Cooperative PRMT5 Inhibitor in Recurrent Glioblastoma Participants With MTAP Deleted Tumors Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-Triggered Expansion Cohort", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-04-28", "PrimaryCompletionDate": "2026-09-28", "Interventions": [ { "Name": "BMS-986504", "Type": "DRUG", "Description": "MTA cooperative PRMT5 inhibitor", "OtherNames": [ "MRTX1719" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05941234", "BriefTitle": "Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma", "OfficialTitle": "Improving Personalised Glioblastoma Care by Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence Approaches", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-02-29", "PrimaryCompletionDate": "2026-05-30", "Interventions": [ { "Name": "Biological biomarker analysis", "Type": "OTHER", "Description": "Collection of tumor and blood samples at T0 (surgery) and T1 (6 months follow-up) Tumor microenvironment and blood multi-omics analysis In-depth functional characterization of tumor microenvironment Cancer stem cells generation and drug testing Data integration by business intelligence and development of AI-based prognostic markers", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [ "Oslo University Hospital", "Istituto Superiore di Sanità", "Luxembourg Institute of Health", "Hospital Donostia", "University Medical Center Goettingen", "National Research Council" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02869243", "BriefTitle": "A Dose Escalation Phase I Study Of Human- Recombinant Bone Morphogenetic Protein 4 Administrated Via CED In GBM Patients", "OfficialTitle": "A Dose Escalation Phase I Study Of Human- Recombinant Bone Morphogenetic Protein 4 Administrated Via Convection-Enhanced Delivery In Patients With Progressive And/Or Multiple Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-07-18", "PrimaryCompletionDate": "2020-10-16", "Interventions": [ { "Name": "hrBMP4", "Type": "DRUG", "Description": "Patients will undergo a resection or biopsy of the tumour, confirmation of viable malignant glioma tumour cells and intratumour/interstitial placement under neuronavigational guidance of 2 or 3 catheters.\n\nCatheters will be placed during a second procedure a few days later based upon the patient's condition.\n\nPatients will receive intra-tumour and interstitial CED of increasing amounts of hrBMP4 solutions (starting dose of 0.5 mg) and 1:70 gadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) in a total of 44-66ml over up to 4-6 days. Gd-DTPA will be co-infused with BMP4 to determine the extent of intra-tumour and interstitial drug delivery. HrBMP4 will be delivered as a continuous infusion via the intracranial catheters.", "OtherNames": [ "Recombinant Bone Morphogenic Protein-4", "Device:Intracranial Catheter" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stemgen", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "ORION Clinical Services" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04160494", "BriefTitle": "D2C7-IT With Atezolizumab for Recurrent Gliomas", "OfficialTitle": "A Phase 1 Trial of D2C7-IT in Combination With Atezolizumab in Recurrent WHO Grade IV Malignant Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-02-25", "PrimaryCompletionDate": "2024-06-28", "Interventions": [ { "Name": "D2C7-IT (6920 ng/mL via convection-enhanced delivery)", "Type": "DRUG", "Description": "dual-specific mAB", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Atezolizumab (1200 mg every three weeks)", "Type": "DRUG", "Description": "programmed cell death ligand 1 (PD-L1) blocking antibody", "OtherNames": [ "Tecentriq" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)", "Type": "DRUG", "Description": "dual-specific mAB", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Darell Bigner", "LeadSponsorClass": "OTHER", "Collaborators": [ "Istari Oncology, Inc.", "National Cancer Institute (NCI)", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT00525525", "BriefTitle": "Study of Bevacizumab Plus Temodar and Tarceva in Patients With Glioblastoma or Gliosarcoma", "OfficialTitle": "A Phase II Study of Bevacizumab Plus Temodar and Tarceva After Radiation Therapy and Temodar in Patients With Newly Diagnosed Glioblastoma or Gliosarcoma Who Are Stable Following Radiation", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-09", "PrimaryCompletionDate": "2013-05", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Patients are given 10 mg/kg IV Q2 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Tarceva", "Type": "DRUG", "Description": "Patients receive 150 mg PO daily. If patients are not experiencing intolerable toxicity, they may escalate their dose to 200 mg PO daily. If patients are experiencing intolerable toxicity, their dose will be held until the toxicity improves or resolves, then re-treated at a lower dose level, i.e. 100 mg PO daily.", "OtherNames": [ "Erlotonib" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients receive 200 mg/m2 for Days 1-5 of every 28 day cycle. Although the calendar days may be slightly altered, the patient should always receive this dose for 5 days within a treatment cycle. If the patient experiences certain toxicities specified in the protocol, Temodar will be held then given at a reduced dose, i.e. 150 mg/m2 Days 1-5.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02026271", "BriefTitle": "A Study of Ad-RTS-hIL-12 With Veledimex in Subjects With Glioblastoma or Malignant Glioma", "OfficialTitle": "A Phase I Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-06", "PrimaryCompletionDate": "2019-08", "Interventions": [ { "Name": "Ad-RTS-hIL-12", "Type": "BIOLOGICAL", "Description": "* 2.0 x 10\\^11 viral particles (vp) per injection or 1.0 x 10\\^12 viral particles (vp) per injection\n* one intratumoral injection of Ad-RTS-hIL-12", "OtherNames": [ "INXN-2001" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "veledimex", "Type": "DRUG", "Description": "* 4 doses (20mg/day, 40mg/day, 80mg/day, and 120mg/day)\n* 14 oral daily doses of veledimex\n* 1 Expansion cohort at a single dose level at or below MTD", "OtherNames": [ "INXN-1001", "Activator Ligand" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alaunos Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01113463", "BriefTitle": "TPI 287 in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients With Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy With Radiation Plus Temozolomide", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2010-04", "PrimaryCompletionDate": "2011-06", "Interventions": [ { "Name": "TPI 287", "Type": "DRUG", "Description": "Starting dose of 160 mg/m\\^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cortice Biosciences, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03890952", "BriefTitle": "Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma", "OfficialTitle": "A Phase II Open Label, Two-armed Translational Study of Nivolumab in Combination With Bevacizumab for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-10-01", "PrimaryCompletionDate": "2023-02-01", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Treatment with the combination of Nivolumab and bevacizumab every 2 weeks", "OtherNames": [ "Checkpoint inhibitor" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Checkpoint inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Treatment with the combination of Nivolumab and bevacizumab every 2 weeks", "OtherNames": [ "Angiogenesis inhibitor" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Ulrik Lassen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Herlev Hospital", "University of Copenhagen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00814593", "BriefTitle": "Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery", "OfficialTitle": "Randomized Phase II Trial of Intralesional Lymphokine Activated Killer Cells or Polifeprosan 20 With Carmustine Implant (Gliadel® Wafer) as Consolidation Therapy After Primary Treatment of Newly Diagnosed Resectable Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2008-11", "PrimaryCompletionDate": "2011-04", "Interventions": [ { "Name": "lymphokine-activated killer cells", "Type": "BIOLOGICAL", "Description": "Instilled into the tumor bed cavity", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "polifeprosan 20 with carmustine implant", "Type": "DRUG", "Description": "Intracranial placement", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Lisata Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00028158", "BriefTitle": "Safety and Effectiveness Study of G207, a Tumor-Killing Virus, in Patients With Recurrent Brain Cancer", "OfficialTitle": "An Open-Label Phase Ib/II Study of the Safety, Tolerability and Efficacy of G207, a Genetically Engineered Herpes Simplex Type-1 Virus, Administered Intracerebrally to Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-12", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "G207, an oncolytic virus", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "MediGene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00943826", "BriefTitle": "A Study of Bevacizumab (Avastin®) in Combination With Temozolomide and Radiotherapy in Participants With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2009-06-29", "PrimaryCompletionDate": "2013-02-28", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "10 mg/kg intravenously q2w in the Concurrent and Maintenance Phases. 15 mg/kg intravenously q3w in the Monotherapy Phase.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "75 mg/m\\^2 once daily for 6 weeks, followed by 150-200 mg/m\\^2 once daily on days 1-5 of six 4 week cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "30 fractions of 2 Gy delivered on days 1-5 per week for 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Intravenously q2w in the Concurrent and Maintenance Phases and q3w in the Monotherapy Phase.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hoffmann-La Roche", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00002608", "BriefTitle": "Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors", "OfficialTitle": "Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1994-05", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "cisplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "doxorubicin hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "tamoxifen citrate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ottawa Regional Cancer Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01443676", "BriefTitle": "Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma", "OfficialTitle": "Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-10", "PrimaryCompletionDate": "2015-08", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be added to radiotherapy", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Radiation therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Zurich", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00004129", "BriefTitle": "Phosphorus 32 in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "1999-09", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "brachytherapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "phosphorus P32", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Center for Molecular Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00238173", "BriefTitle": "Acetylcysteine, Mannitol, Combination Chemotherapy, and Sodium Thiosulfate in Treating Children With Malignant Brain Tumors", "OfficialTitle": "Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2004-12", "PrimaryCompletionDate": "2006-02-17", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "acetylcysteine", "Type": "DRUG", "Description": "administered i.v. over 30 to 60 minutes", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": "(200 mg/m2/day; total dose 400 mg/m2) will be infused i.a. over 10 minutes, in 50-180 cc of normal saline.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": "(330 mg/m2/day; total dose 660 mg/m2) will be infused i.v. in 25-50 cc of normal saline, over approximately 10 minutes.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "etoposide phosphate", "Type": "DRUG", "Description": "(200 mg/m2/day; total dose 400 mg/m2) will be infused i.v. in 25-100 cc of normal saline, over approximately 10 minutes, immediately following the cyclophosphamide.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "mannitol", "Type": "DRUG", "Description": "(25%) delivered i.a. at a pre-determined flow rate over 30 seconds. The flow rate will be determined by iodinated contrast injection and fluoroscopy as the lowest infusion rate in which there is retrograde flow from the arterial catheter. The rate and volume of mannitol infused will be approximately 4-12 cc/sec x 30 seconds.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sodium thiosulfate", "Type": "DRUG", "Description": "STS is available as a 25% (250 mg/ml) solution. The dose of STS administered 4 hours after carboplatin is 16 gm/m2. The dose of STS administered 8 hours after carboplatin is 16 gm/m2. Actual dose to be administered will be determined and mixed with an equivalent amount of sterile water (1 ml:1 ml) for infusion.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "OHSU Knight Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00977795", "BriefTitle": "A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors", "OfficialTitle": "A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2010-01", "Interventions": [ { "Name": "5-aminolevulinic acid", "Type": "DRUG", "Description": "oral doses in phase 1 study of 10mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg", "OtherNames": [ "5-ALA", "aminolevulinic acid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Endeavor Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06855628", "BriefTitle": "Assessment of Novel Metabolic Imaging Modalities as A Predictor Of Therapeutic EfficacyiIn Glioblastoma (GBM)", "OfficialTitle": "Assessment Of A Novel Metabolic Imaging Modalities As A Predictor Of Therapeutic Efficacy In Glioblastoma (GBM)", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE2" ], "StartDate": "2025-01-30", "PrimaryCompletionDate": "2028-02", "Interventions": [ { "Name": "[6,6-²H₂]-Glucose", "Type": "OTHER", "Description": "\\[6,6-²H₂\\]-Glucose is a stable isotope-labeled glucose used as a metabolic tracer. It is administered orally to assess glucose metabolism using Deuterium Metabolic Imaging (DMI).", "OtherNames": [ "Deuterated Glucose Tracer", "Stable Isotope-Labeled Glucose", "D-Glucose, [6,6-²H₂]" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05476341", "BriefTitle": "A Phase I Clinical Trial of Bevacizumab Injection", "OfficialTitle": "A Randomized, Double-blind, Single Dose, Parallel Comparison of Bevacizumab Injection and Avastin ® Phase I Clinical Study on the Similarity of Pharmacokinetics and Safety of Traditional Chinese Medicine in Healthy Male Volunteers", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-04-06", "PrimaryCompletionDate": "2017-08-18", "Interventions": [ { "Name": "Bevacizumab injection", "Type": "DRUG", "Description": "Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab injection（Avastin）", "Type": "DRUG", "Description": "Recombinant humanized monoclonal antibody injection against human vascular endothelial growth factor", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Chia Tai Tianqing Pharmaceutical Group Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03684811", "BriefTitle": "A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation", "OfficialTitle": "A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-11-01", "PrimaryCompletionDate": "2021-05-24", "Interventions": [ { "Name": "FT-2102", "Type": "DRUG", "Description": "FT-2102 will be supplied as a 150 mg capsule and will be administered per the protocol defined frequency and dose level.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Azacitidine", "Type": "DRUG", "Description": "Azacitidine will be administered per the site's standard of care.", "OtherNames": [ "Vidaza" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "BIOLOGICAL", "Description": "Nivolumab will be administered per the site's standard of care.", "OtherNames": [ "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH", "PD-1" ], "classes": [] } }, { "Name": "Gemcitabine and Cisplatin", "Type": "DRUG", "Description": "Gemcitabine and cisplatin will be administered per the site's standard of care.", "OtherNames": [ "Gemzar and Platinol" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Forma Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "PD-1" ], "classes": [] } }, { "NCTId": "NCT00864864", "BriefTitle": "Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma", "OfficialTitle": "Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2007-05", "PrimaryCompletionDate": "2011-05", "Interventions": [ { "Name": "Sunitinib", "Type": "DRUG", "Description": "Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Brigham and Women's Hospital", "Dana-Farber Cancer Institute", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02663271", "BriefTitle": "TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma", "OfficialTitle": "A Phase 2, Multi-center, Single Arm, Histologically Controlled Study Testing the Combination of TTFields and Pulsed Bevacizumab Treatment in Patients With Bevacizumab-refractory Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2016-12-19", "PrimaryCompletionDate": "2021-06-11", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be given at 10mg/kg IV every 2 weeks.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Optune", "Type": "DEVICE", "Description": "Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.", "OtherNames": [ "NovoTTF™-100A System" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Brain MRI", "Type": "OTHER", "Description": "Brain MRI will be done at screening and every 8 weeks.", "OtherNames": [ "Magnetic resonance imaging" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Quality of Life Questionnaires", "Type": "OTHER", "Description": "The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.", "OtherNames": [ "Karnofsky Performance Scale", "MMSE" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04485949", "BriefTitle": "A Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma", "OfficialTitle": "A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF-1R, in Newly Diagnosed Patients With Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-03-20", "PrimaryCompletionDate": "2026-04", "Interventions": [ { "Name": "IGV-001 Cell Immunotherapy", "Type": "COMBINATION_PRODUCT", "Description": "IGV-001, an immunotherapeutic product that combines personalized whole tumor-derived cells with an antisense oligonucleotide (IMV-001) in implantable biodiffusion chambers.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "COMBINATION_PRODUCT", "Description": "Placebo in implantable biodiffusion chambers containing a predetermined inactive solution.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standard of Care (SOC): Radiation Therapy", "Type": "PROCEDURE", "Description": "Radiation therapy administered per institutional standards.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "SOC: Temozolomide", "Type": "DRUG", "Description": "Temozolomide administered orally.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Imvax", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01956734", "BriefTitle": "Virus DNX2401 and Temozolomide in Recurrent Glioblastoma", "OfficialTitle": "Phase I Trial of Combination of DNX-2401 (Formerly Named Delta-24-RGD) Oncolytic Adenovirus With a Short Course of Temozolomide for Treatment of Glioblastoma at First Recurrent", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-09", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "DNX2401 and Temozolomide", "Type": "PROCEDURE", "Description": "Virus injection in the brain parenchyma after pathology confirmation of recurrent glioblastoma.\n\nTemozolomide oral 14 days after virus injection.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Clinica Universidad de Navarra, Universidad de Navarra", "LeadSponsorClass": "OTHER", "Collaborators": [ "DNAtrix, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03011671", "BriefTitle": "Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma", "OfficialTitle": "A Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide in Adults With Newly Diagnosed MGMT Promoter-Methylated IDH Wildtype Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-10-03", "PrimaryCompletionDate": "2025-03-14", "Interventions": [ { "Name": "Acetazolamide", "Type": "DRUG", "Description": "ACZ will be given at an initial dose of 250 mg twice a day (BID) and then escalated to 500 mg BID after 1 week. ACZ will be given on days 1-21 of each cycle.", "OtherNames": [ "Diamox", "Diamox Sequels" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "For cycle 1 of the maintenance phase, TMZ will administered at 150 mg/m2 on days 1- 5 followed by 23 days with no drug. For cycles 2- 6, TMZ can be increased to 200 mg/m2 at the discretion of the treating investigator.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Chicago", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03072134", "BriefTitle": "Neural Stem Cell Based Virotherapy of Newly Diagnosed Malignant Glioma", "OfficialTitle": "Neural Stem Cell Oncolytic Adenoviral Virotherapy of Newly Diagnosed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-04-24", "PrimaryCompletionDate": "2020-04-06", "Interventions": [ { "Name": "Neural stem cells loaded with an oncolytic adenovirus", "Type": "BIOLOGICAL", "Description": "The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.", "OtherNames": [ "NSC-CRAd-Survivin-pk7" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05698199", "BriefTitle": "Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)", "OfficialTitle": "A Phase I, Open Label, First In Humans (FIH), Single Dose Level Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of ITI-1001 In Patients With Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-08-21", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "ITI-1001", "Type": "DRUG", "Description": "ITI-1001 DNA vaccine represents a multi-antigen nucleic acid cancer immunotherapy encoding 3 CMV antigens. The vaccine is comprised of 2 DNA plasmids: 1 plasmid encoding IE-1 and pp65 antigens as a fusion protein with LAMP1. Another plasmid encodes gB antigen as a fusion protein with LAMP1.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Immunomic Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00039364", "BriefTitle": "Imatinib Mesylate in Treating Patients With Gliomas", "OfficialTitle": "Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-03", "PrimaryCompletionDate": "2004-08", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT04446416", "BriefTitle": "Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients", "OfficialTitle": "An Open Label, Prospective, Pilot Study to Evaluate the Efficacy and Safety of Best Physician's Choice of Standard of Care Combined With NaviFUS System in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2020-07-21", "PrimaryCompletionDate": "2022-09-30", "Interventions": [ { "Name": "NaviFUS System", "Type": "DEVICE", "Description": "Open the BBB using focused ultrasound and contrast agent SonoVue®", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "An anti-angiogenic agent to block tumor growth", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "NaviFUS Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Chang Gung Memorial Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00079092", "BriefTitle": "Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma", "OfficialTitle": "A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-01-01", "PrimaryCompletionDate": "2006-03-21", "Interventions": [ { "Name": "procarbazine hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "thalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01811992", "BriefTitle": "Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma", "OfficialTitle": "A Non-randomized, Open-label Dose-finding Trial of Combined Cytotoxic and Immune-Stimulatory Strategy for the Treatment of Resectable Primary Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-04", "PrimaryCompletionDate": "2019-02", "Interventions": [ { "Name": "Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L", "Type": "BIOLOGICAL", "Description": "Two adenoviral vectors will be used, each to deliver one of the therapeutic genes. Both vectors are human serotype 5, replication-defective, first generation adenoviral vectors deleted in E1a and E3 viral encoding regions. Each vector will constitutively express their respective therapeutic transgene (i.e. HSV1-TK or Flt3L) under the control of the human cytomegalovirus promoter (hCMV). Valacyclovir treatment will begin 1-3 days after vector administration at a dose of 2 grams given orally 3X per day for 14 days. A second course of valacyclovir will be given beginning Week 10.\n\nRadiation and chemotherapy will be administered as per standard of care.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Michigan Rogel Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Phase One Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02122822", "BriefTitle": "Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96", "OfficialTitle": "Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-07", "PrimaryCompletionDate": "2015-07", "Interventions": [ { "Name": "gp96", "Type": "BIOLOGICAL", "Description": "vaccination of autologous gp96 derived from tumor tissue + basal treatment", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cure&Sure Biotech Co., LTD", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Beijing Tiantan Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00100802", "BriefTitle": "Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas", "OfficialTitle": "A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-03-21", "PrimaryCompletionDate": "2012-09-01", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea", "1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-", "Belustin", "Belustine", "CCNU", "Cecenu", "CeeNU", "Chloroethylcyclohexylnitrosourea", "Citostal", "Gleostine", "Lomeblastin", "Lomustinum", "Lucostin", "Lucostine", "N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea", "Prava", "RB-1509", "WR-139017" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00635557", "BriefTitle": "Phase 1 Study of MPC-6827 and Carboplatin in Recurrent/Relapsed Glioblastoma Multiforme", "OfficialTitle": "Dose Finding Phase 1 Study of the Treatment of Recurrent/Relapsed Glioblastoma Multiforme With MPC-6827 in Combination With Carboplatin", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-03", "PrimaryCompletionDate": "2010-10", "Interventions": [ { "Name": "MPC-6827 + Carboplatin", "Type": "DRUG", "Description": "MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Myrexis Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05084430", "BriefTitle": "Study of Pembrolizumab and M032 (NSC 733972)", "OfficialTitle": "A Phase I/II Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive and Newly Diagnosed Glioblastoma Multiforme, Grade 3 or Grade 4 Astrocytoma, or Gliosarcoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-02-25", "PrimaryCompletionDate": "2027-03-01", "Interventions": [ { "Name": "M032", "Type": "DRUG", "Description": "Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Starting at week four, patients will undergo treatment on the same day, and every three weeks thereafter, with intravenous infusion of 200mg of Pembrolizumab . A total of 3 combined doses of Pembrolizumab and M032 will be given.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT04825275", "BriefTitle": "Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial", "OfficialTitle": "Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: A Phase 0 Clinical Trial", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-05-13", "PrimaryCompletionDate": "2024-11-06", "Interventions": [ { "Name": "Posaconazole Pill", "Type": "DRUG", "Description": "300 mg (three 100 mg tablets) orally", "OtherNames": [ "Noxafil" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Milton S. Hershey Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00623077", "BriefTitle": "MT2004-30: Tomotherapy for Solid Tumors", "OfficialTitle": "Dose Escalation of Total Marrow Irradiation Added to an Alkylator-Intense Conditioning Regimen for Patients With High Risk or Relapsed Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2005-08", "PrimaryCompletionDate": "2012-07", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Beginning 24 hours after chemotherapy end: 10 microgram/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophile count (ANC) \\> 1,000/mm\\^2.\n\nStarting that day, increase dose to 15 microgram/kg/day SQ or IV given as a single injection for 3 doses.", "OtherNames": [ "G-CSF", "Sargramostim" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "busulfan", "Type": "DRUG", "Description": "Part of pre-transplant conditioning chemotherapy: Administered as Busulfan 9.6 mg/kg IV (\\>4 yrs of age) or 13.2 mg/kg IV (\\< 4 years of age),every 6 hours on Days -8 through -6.", "OtherNames": [ "Busulfex", "Myleran" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": "Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 100 mg/m\\^2/day intravenous (IV) over 1 hour for 5 days.", "OtherNames": [ "Eposin", "VP-16" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "ifosfamide", "Type": "DRUG", "Description": "Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m\\^2/day intravenous (IV) over 1 hour on for 5 days.", "OtherNames": [ "Mitoxana", "Ifex" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "melphalan", "Type": "DRUG", "Description": "Part of pre-transplant conditioning chemotherapy: Administered as 100 mg/m\\^2 intravenous (IV) over 30 min on Days -5 through -4.", "OtherNames": [ "Alkeran" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": "Part of pre-transplant conditioning chemotherapy: Administered as 500 mg/m\\^2 intravenously (IV) over 2 hrs on Days -3 through -2.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "stem cell transplantation", "Type": "PROCEDURE", "Description": "Regardless of whether the patient will be receiving peripheral cells or bone marrow, infusion will be intravenous on day 0, immediately after thawing.", "OtherNames": [ "HPC infusion" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "tomotherapy", "Type": "RADIATION", "Description": "We plan to deliver the total marrow irradiation (TMI) to the upper half of the body using Tomotherapy TMI as explained in this protocol. However the lower part of the body will be treated with Anterior/Posterior linac based radiation treatment. Tomotherapy will then be delivered at a dose rate so as to keep the total treatment time to no more than 30 minutes. We anticipate that the dose rate will be around 400 cGy\n\n/minute (instantaneous dose rate).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "total marrow irradiation", "Type": "RADIATION", "Description": "TMI will be delivered to all bony sites as part of the conditioning. Additional \"spot\" therapy to PET positive lesions, primary disease (if not previously irradiated to maximum tolerated dose), and lungs will be performed on Day +60. Cohorts of 3 patients will be treated at a total dose of 600 cGy, 900 cGy or 1200 cGy on Days -11 through -9.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "Mesna", "Type": "DRUG", "Description": "Part of Mobilization chemotherapy and Peripheral blood progenitor cell collections (day -100 to -30): Given as 1.8 g/m\\^2/day divided in every 6 hrs dosing for 5 days.", "OtherNames": [ "Uromitexan®", "Mesnex" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK" ], "classes": [] } }, { "Name": "Whole lung radiation", "Type": "RADIATION", "Description": "At Day 60, patients with prior lung metastasis should receive whole lung irradiation (1500cGy in 10 fractions).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK", "MET" ], "classes": [] } } ], "LeadSponsorName": "Masonic Cancer Center, University of Minnesota", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "MET" ], "classes": [] } }, { "NCTId": "NCT00562419", "BriefTitle": "CT-322 in Treating Patients With Recurrent Glioblastoma Multiforme and Combination Therapy With Irinotecan", "OfficialTitle": "Phase 2, 2-Part, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of CT-322 Monotherapy and Combination Therapy With Irinotecan in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2011-06", "Interventions": [ { "Name": "CT-322", "Type": "DRUG", "Description": "IV solution, weekly", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": "IV solution, biweekly", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Adnexus, A Bristol-Myers Squibb R&D Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04406272", "BriefTitle": "VB-111 in Surgically Accessible Recurrent/Progressive GBM", "OfficialTitle": "A Randomized, Controlled Phase II Surgical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters for the Viral Cancer Therapy Ofranergene Obadenovec (VB-111) in Patients With Surgically Accessible Recurrent/Progressive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2020-08-01", "PrimaryCompletionDate": "2024-08-01", "Interventions": [ { "Name": "VB11", "Type": "DRUG", "Description": "Intravenously administered type of gene therapy that works by blocking the process of blood-vessel creation. Disrupting a cancer from growing blood vessels, might slow the growth of the cancer or shrink it.", "OtherNames": [ "Ofranergene obadenovec" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "Intravenous solution that has no therapeutic effect, used as a control in testing investigational drug.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "A type of antibody, Bevacizumab is intravenously administered and works by binding to and disrupting the vascular endothelial growth factor (VEGF). VEGF is a signal protein produced by cells that stimulates the formation of blood vessels. By disrupting VEGF, Bevacizumab helps to prevent the growth and maintenance of tumor blood vessels.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Vascular Biogenics Ltd. operating as VBL Therapeutics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06623565", "BriefTitle": "Extensive Resection of Malignant Brain Tumors Using Advanced Imaging Techniques", "OfficialTitle": "Multimodal Image-guided Resection of IDH Wildtype Glioblastoma and Grade IV IDH-mutant Astrocytoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-04-01", "PrimaryCompletionDate": "2026-04", "Interventions": [ { "Name": "Multimodal image-guided resection", "Type": "PROCEDURE", "Description": "Supramarginal resection using combination of ADC MRI and FET PET", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Amsterdam UMC, location VUmc", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT03150862", "BriefTitle": "A Study Assessing Pamiparib With Radiation and/or Temozolomide (TMZ) in Participants With Newly Diagnosed or Recurrent Glioblastoma", "OfficialTitle": "A Phase 1b/2 Study to Assess the Safety, Tolerability and Efficacy of BGB-290 in Combination With Radiation Therapy (RT) and/or Temozolomide (TMZ) in Subjects With First-line or Recurrent/Refractory Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-07-24", "PrimaryCompletionDate": "2021-03-17", "Interventions": [ { "Name": "Pamiparib", "Type": "DRUG", "Description": "Administered as specified in the treatment arm", "OtherNames": [ "BGB-290" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TMZ", "Type": "DRUG", "Description": "Administered as specified in the treatment arm", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Up to 60 Gy (total) over 6 - 7 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "BeiGene USA, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00008086", "BriefTitle": "Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors", "OfficialTitle": "A Phase I Trial of Subcutaneous And/Or Oral Calcitriol [(1,25-COH)2D3] and Carboplatin in Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1996-01", "PrimaryCompletionDate": "2004-09", "Interventions": [ { "Name": "calcitriol", "Type": "DIETARY_SUPPLEMENT", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Pittsburgh", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00014443", "BriefTitle": "Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma", "OfficialTitle": "A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2000-08", "PrimaryCompletionDate": "2003-08", "Interventions": [ { "Name": "thalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "topotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Rush University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07263438", "BriefTitle": "Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma: a Phase 2 Trial", "OfficialTitle": "Open-label Phase II Clinical Trial to Test the Efficacy of the Combination of Trimipramine and Atezolizumab With Bevacizumab in Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-11-03", "PrimaryCompletionDate": "2028-03-30", "Interventions": [ { "Name": "Trimipramine", "Type": "DRUG", "Description": "Trimipramine: daily oral intake at 75mg/ day for 7 days, then at 150 mg/ day", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Cohort 1: Atezolizumab", "Type": "BIOLOGICAL", "Description": "Atezolizumab: intravenous administration at 1200 mg on the first day of 3-week cycles.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Cohort 2: Atezolizumab", "Type": "BIOLOGICAL", "Description": "Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on the first day of 3-week cycles. Administration will occur once, then will be interrupted during a recovery period of 14-days post surgery, and then resumed.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Cohort 2: Bevacizumab", "Type": "BIOLOGICAL", "Description": "Bevacizumab will be administered intravenously at 15 mg/kg on the first day of 3-week cycles. The first administration will take place 5 weeks after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire Vaudois", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-L1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03374943", "BriefTitle": "A Trial of KB004 in Patients With Glioblastoma", "OfficialTitle": "A Phase I Safety and Bioimaging Trial of KB004 in Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-12-05", "PrimaryCompletionDate": "2021-01-25", "Interventions": [ { "Name": "KB004", "Type": "DRUG", "Description": "KB004 is a recombinant, non-fucosylated, IgG1κ (human f-allotype) monoclonal antibody targeting the extracellular ligand binding domain of the EphA3 (ephrin receptor) tyrosine kinase", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Olivia Newton-John Cancer Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Humanigen, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01933815", "BriefTitle": "Dose-Escalation Study of TPI 287 + Avastin Followed by Randomized Study of the Same Versus Avastin for Glioblastoma", "OfficialTitle": "Phase 1/2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab Followed by Randomized Study of the Maximum Tolerated Dose of TPI 287 in Combination With Bevacizumab Versus Bevacizumab Alone in Adults With Recurrent Glioblastoma", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-08", "PrimaryCompletionDate": "2024-11", "Interventions": [ { "Name": "TPI 287", "Type": "DRUG", "Description": "TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.", "OtherNames": [ "TPI-287", "NBT 287" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Cortice Biosciences, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04523688", "BriefTitle": "Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma", "OfficialTitle": "Vaccination With Autologous Dendritic Cells Loaded With Autologous Tumour Homogenate in Glioblastoma: a Phase II Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2021-03-25", "PrimaryCompletionDate": "2025-07", "Interventions": [ { "Name": "Autologous Dendritic Cells (DC) vaccine", "Type": "BIOLOGICAL", "Description": "10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Adjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05700955", "BriefTitle": "Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma", "OfficialTitle": "A Phase I Trial of Neoadjuvant Chemoimmunotherapy in Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2022-11-01", "PrimaryCompletionDate": "2025-01", "Interventions": [ { "Name": "Pembrolizumab and Temozolomide", "Type": "DRUG", "Description": "Characterize the safety and immunologic/genomic/metabolomic effects of neoadjuvant Pembrolizumab and Temozolomide in recurrent glioblastoma.", "OtherNames": [ "Pembro and Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Louisville", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06439420", "BriefTitle": "CBT-I in Primary Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial", "OfficialTitle": "Cognitive Behavioral Therapy for Insomnia in Brain Tumor Patients: Phase IIc Randomized Feasibility Pilot Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2024-07-08", "PrimaryCompletionDate": "2025-09-25", "Interventions": [ { "Name": "Cognitive Behavioral Therapy for Insomnia", "Type": "BEHAVIORAL", "Description": "CBT-I is a non-pharmacological approach to treating sleep disturbance consisting of educational, behavioral, and cognitive intervention components with evidence-based strategies including sleep efficiency, stimulus control, and sleep hygiene modification. CBT-I includes at least 6 group sessions, each approximately 90 minutes in length, delivered over 6 weeks via telehealth.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Virginia Commonwealth University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02754362", "BriefTitle": "A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma", "OfficialTitle": "A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2016-11", "PrimaryCompletionDate": "2019-06", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.", "OtherNames": [ "Hiltonol®" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Peptide Vaccine", "Type": "BIOLOGICAL", "Description": "Vaccine of long synthetic peptides encoding T cell epitopes in tumor associated antigens.\n\nVaccine Consists of:\n\nEGFRvIII peptide 100 mcg IL13Ralpha peptide 100 mcg EphA2 peptide 100 mcg Her2/neu peptide 100 mcg YKL-40 peptide 100 mcg", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Poly-ICLC as immune adjuvant", "Type": "DRUG", "Description": "Poly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Keyhole limpet hemocyanin (KLH)", "Type": "DRUG", "Description": "Potent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "MOUNT SINAI HOSPITAL" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01522820", "BriefTitle": "Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors", "OfficialTitle": "A Phase I Clinical Trial of mTOR Inhibition With Rapamycin for Enhancing Intranodal Dendritic Cell Vaccine Induced Anti-tumor Immunity in Patients With NY-ESO-1 Expressing Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-03", "PrimaryCompletionDate": "2016-07", "Interventions": [ { "Name": "DEC-205/NY-ESO-1 Fusion Protein CDX-1401", "Type": "BIOLOGICAL", "Description": "Given intranodally", "OtherNames": [ "CDX-1401" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Sirolimus", "Type": "DRUG", "Description": "Given PO or PEG", "OtherNames": [ "AY 22989", "RAPA", "Rapamune", "RAPAMYCIN", "SILA 9268A", "WY-090217" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Roswell Park Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT05590689", "BriefTitle": "Radiodynamic Therapy (RDT) With Gliolan in Patients With First Recurrence of Brain Tumor", "OfficialTitle": "Phase I/II Dose Escalation Trial of Radiodynamic Therapy (RDT) With 5-Aminolevulinic Acid in Patients With First Recurrence of Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-11-09", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "Gliolan", "Type": "DRUG", "Description": "A repetitive dose of Gliolan will be administrated in combination with radiotherapy (radiodynamic therapy)", "OtherNames": [ "5-Aminolevulinic acid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiodynamic therapy", "Type": "RADIATION", "Description": "Radiotherapy will be performed in combination with Gliolan administration", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Universität Münster", "LeadSponsorClass": "OTHER", "Collaborators": [ "photonamic GmbH & Co. KG" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00684567", "BriefTitle": "Temozolomide Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme (Study P04661)(COMPLETED)", "OfficialTitle": "SCH 52365 Phase II Clinical Study in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-09-27", "PrimaryCompletionDate": "2007-10-31", "Interventions": [ { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Radiotherapy will be administered in combination with temozolomide during the concomitant radiotherapy phase. Radiotherapy will consist of a conventionally fractioned regimen, delivering a total dose of 60 Gy in 6 weeks, in a once daily schedule of 2 Gy per fraction, for a total of 30 fractions. Radiation will be provided by a linear accelerator of x ray energy of 4 MV or higher.", "OtherNames": [ "Irradiation, radiation therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "During the concomitant radiotherapy phase (6 weeks), temozolomide will be administered in combination with radiotherapy, once daily at 75 mg/m2/day. Then, during the monotherapy phase, subjects will receive 6 cycles of temozolomide alone. Each cycle will last 28 days, and temozolomide will be administered once daily from Day 1 to Day 5 of each cycle. The dose of temozolomide in the first cycle will be 150 mg/m2/day, and may be increased to 200 mg/m2/day for Cycle 2 and subsequent cycles depending on nonhematologic toxicity observed and neutrophil and platelet count values. Capsules containing 5 mg, 20 mg, or 100 mg of temozolomide will be combined to achieve each subject's calculated dose.", "OtherNames": [ "Temodal, Temodar, SCH 052365" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01445691", "BriefTitle": "More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery", "OfficialTitle": "A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2015-11", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "5-ALA (Gliolan)", "Type": "DRUG", "Description": "20 mg/kg administered once 3-5 hours prior to surgery", "OtherNames": [ "5-ALA", "Aminolevulinic acid", "Gliolan" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Constantinos Hadjipanayis", "LeadSponsorClass": "OTHER", "Collaborators": [ "NX PharmaGen", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06161974", "BriefTitle": "Study of Olutasidenib and Temozolomide in HGG", "OfficialTitle": "Phase 2 Study of Olutasidenib with Temozolomide As Maintenance Therapy in Pediatric and Young Adult Patients Newly Diagnosed with High-Grade Glioma (HGG), Including Diffuse Intrinsic Pontine Glioma (DIPG), Which Harbor IDH1 Mutations", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-03", "PrimaryCompletionDate": "2029-06", "Interventions": [ { "Name": "Olutasidenib + TMZ", "Type": "DRUG", "Description": "Olutasidenib 150 mg PO BID + Temozolomide 200 mg/m2 PO QD", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Rigel Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Nationwide Children's Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03734913", "BriefTitle": "A Phase 1 Study of ZSP1602 in Participants With Advanced Solid Tumors", "OfficialTitle": "A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1602 in Participants With Advanced Solid Tumors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2019-01-25", "PrimaryCompletionDate": "2021-07-31", "Interventions": [ { "Name": "ZSP1602", "Type": "DRUG", "Description": "ZSP1602 capsules for oral administration", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Guangdong Zhongsheng Pharmaceutical Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05017610", "BriefTitle": "Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma or Gliosarcoma", "OfficialTitle": "A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Inducing a Hypothyroxinemic State in Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-10-20", "PrimaryCompletionDate": "2022-10-14", "Interventions": [ { "Name": "Liothyronine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "L-Triiodothyronine", "Therapeutic T3", "Triiodothyronine" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea", "1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-", "Belustin", "Belustine", "CCNU", "Cecenu", "CeeNU", "Chloroethylcyclohexylnitrosourea", "Citostal", "Gleostine", "Lomeblastin", "Lomustinum", "Lucostin", "Lucostine", "N-(2-Chloroethyl)-N''-cyclohexyl-N-nitrosourea", "Prava", "RB-1509", "WR-139017" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Methimazole", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Tapazole" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01729260", "BriefTitle": "Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide", "OfficialTitle": "Phase I Study of Mebendazole in Newly Diagnosed High-Grade Glioma Patients Receiving Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-04-04", "PrimaryCompletionDate": "2016-09", "Interventions": [ { "Name": "Mebendazole", "Type": "DRUG", "Description": "The mebendazole will be given by mouth three times every day on a 28 day cycle. it's in the form of 500 mg chewable tablets, to be taken with meals.", "OtherNames": [ "Brand name: Vermox" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Accelerate Brain Cancer Cure" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05683808", "BriefTitle": "Venous Thromboembolism Prevention in Outpatients With Glioma", "OfficialTitle": "Venous Thromboembolism Prevention in Outpatients With Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2023-01-16", "PrimaryCompletionDate": "2024-06-30", "Interventions": [ { "Name": "Apixaban", "Type": "DRUG", "Description": "Open label", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Vermont Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dartmouth-Hitchcock Medical Center", "MaineHealth" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04530006", "BriefTitle": "Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma", "OfficialTitle": "Acetyl-Amantadine as a Biomarker in Patients With Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-12-02", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Amantadine Hydrochloride", "Type": "DIAGNOSTIC_TEST", "Description": "Patients who are eligible for the study will be administered a regular 200 mg dose of FDA approved drug amantadine. This will be done at the following timepoints:\n\n1. Within 4 weeks of the start of treatment; but as close to commencement of treatment (Day 1 of radiotherapy) as possible for newly diagnosed patients.\n2. Cycle 1, Day 1 of chemotherapy (temozolomide or lomustine) +/- 7 days\n3. Day 1 +/- 7 days for each visit where MRI is obtained (typically every 8-12 weeks - pre-cycles 4, 7, 10, for temozolomide or pre-cycles 3, 5, and 7 for lomustine)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CancerCare Manitoba", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Manitoba", "The Metabolomics Innovation Centre", "BioMark Diagnostics Inc.", "Canadian Institutes of Health Research (CIHR)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01508104", "BriefTitle": "Safety Study of BEZ235 With Everolimus in Subjects With Advanced Solid Tumors", "OfficialTitle": "A Dose Escalation, Single Arm, Phase 1b-2 Combination Study of BEZ235 With Everolimus to Determine the Safety, Pharmacodynamics and Pharmacokinetics in Subjects With Advanced Solid Malignancies", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2012-01", "PrimaryCompletionDate": "2014-02", "Interventions": [ { "Name": "BEZ235", "Type": "DRUG", "Description": "dose escalation 400mg- 1000mg per day", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "dose escalation 2.5 to 5 mg per day", "OtherNames": [ "RAD001" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "University of Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT02684058", "BriefTitle": "Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Pediatric Patients With BRAF V600 Mutation Positive LGG or Relapsed or Refractory HGG Tumors", "OfficialTitle": "Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-12-28", "PrimaryCompletionDate": "2021-08-23", "Interventions": [ { "Name": "Dabrafenib", "Type": "DRUG", "Description": "Dabrafenib was available as 50 mg and 75 mg hard capsules and as 10 mg dispersible tablets for oral suspension. Dabrafenib was administered orally, twice daily, and was dosed based on age and weight Patients \\< 12 years old and ≥ 16 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients ≥ 12 years old and ≥ 19 kg were to be administered either the dabrafenib capsules or dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day) Patients \\< 12 years old and \\< 16 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 5.25 mg/kg/day) Patients ≥12 years old and \\<19 kg were to be administered dabrafenib dispersible tablets for oral suspension (dose: 4.5 mg/kg/day)", "OtherNames": [ "DRB436" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "trametinib", "Type": "DRUG", "Description": "Trametinib was available as 0.5 mg and 2 mg film-coated tablets and as 5.0 mg powder in bottle for oral solution (0.05 mg/ml after reconstitution with 90 ml water).Trametinib was administered orally, once daily in combination with the first daily dose of dabrafenib and was dosed based on age and weight.\n\nPatients \\<6 years old and \\<26 kg were to be administered the trametinib oral solution (dose: 0.032 mg/kg/day) Patients \\<6 years old and ≥26 kg were to be administered either the trametinib oral solution or trametinib tablets (dose: 0.032 mg/kg/day) Patients ≥6 years old and ≥10 kg \\< 33 kg were to be administered the trametinib oral solution (dose: 0.025 mg/kg/day) Patients ≥6 years old and ≥33 kg were to be administered either the trametinib oral solution or the trametinib tablets (dose: 0.025 mg/kg/day)", "OtherNames": [ "TMT212" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Carboplatin was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy. Each maintenance cycle was 6 weeks, and consisted of 4 weeks of chemotherapy with 2 weeks of rest.\n\nInduction: 175 mg/m\\^2 as weekly intravenous (IV) infusion on weeks 1 to 4, and on weeks 7 to 10, on the same day as vincristine dosing Maintenance: 175 mg/m\\^2 as weekly IV infusion over 60 minutes on weeks 1 to 4 of each cycle.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Vincristine", "Type": "DRUG", "Description": "Vincristine was supplied locally as commercially available and labelled accordingly to comply with legal requirements of each country. Vincristine was administered as one course of induction (10 weeks of chemotherapy with 2 weeks of rest), followed by 8 cycles of maintenance chemotherapy.\n\nInduction: 1.5 mg/m\\^2 as weekly IV bolus infusion (0.05 mg/kg if child is \\<12 kg) (maximum dose of 2.0 mg) for 10 weeks.\n\nMaintenance: 1.5 mg/m\\^2 as weekly IV bolus infusion (0.05 mg/kg if child is \\<12 kg) (maximum dose of 2.0 mg) on weeks 1 to 3 of each cycle, on the same day as carboplatin dosing.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT06160206", "BriefTitle": "Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-10-02", "PrimaryCompletionDate": "2026-11-30", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 215", "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF Monoclonal Antibody SIBP04", "Anti-VEGF rhuMAb", "Avastin", "BAT 1706", "BAT-1706", "BAT1706", "BAT1706 Biosimilar", "Bevacizumab awwb", "Bevacizumab Biosimilar ABP 215", "Bevacizumab Biosimilar BAT1706", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar CT-P16", "Bevacizumab Biosimilar FKB238", "Bevacizumab Biosimilar GB-222", "Bevacizumab Biosimilar HD204", "Bevacizumab Biosimilar HLX04", "Bevacizumab Biosimilar IBI305", "Bevacizumab Biosimilar LY01008", "Bevacizumab Biosimilar MIL60", "Bevacizumab Biosimilar Mvasi", "Bevacizumab Biosimilar MYL-1402O", "Bevacizumab Biosimilar QL 1101", "Bevacizumab Biosimilar QL1101", "Bevacizumab Biosimilar RPH-001", "Bevacizumab Biosimilar SCT501", "Bevacizumab Biosimilar Zirabev", "Bevacizumab-adcd", "Bevacizumab-awwb", "Bevacizumab-bvzr", "BP102", "BP102 Biosimilar", "CT-P16", "HD204", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Mvasi", "MYL-1402O", "QL1101", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF", "SCT501", "SIBP 04", "SIBP-04", "SIBP04", "Vegzelma", "Zirabev" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized axial tomography (procedure)", "Computerized Tomography", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Electronic Health Record Review", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Hypofractionated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Hypofractionated", "Hypofractionated Radiotherapy", "hypofractionation", "Radiation, Hypofractionated" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Retifanlimab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "INCMGA 0012", "INCMGA-0012", "INCMGA00012", "INCMGA0012", "MGA 012", "MGA-012", "MGA012", "Retifanlimab-dlwr", "Zynyz" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Academic and Community Cancer Research United", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03744026", "BriefTitle": "Safety and Efficacy of Transient Opening of the Blood-brain Barrier (BBB) With the SonoCloud-9", "OfficialTitle": "A Study to Evaluate the Safety and the Efficacy of Transient Opening of the Blood-brain Barrier (BBB) by Low Intensity Pulsed Ultrasound With the SonoCloud-9 Implantable Device in Recurrent Glioblastoma Patients Eligible for Surgery and for Carboplatin Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2019-02-18", "PrimaryCompletionDate": "2021-06-23", "Interventions": [ { "Name": "SonoCloud-9", "Type": "DEVICE", "Description": "Escalating numbers of ultrasound beams at constant acoustic pressure", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Dose of carboplatin infusion is AUC4-6", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "CarThera", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01753713", "BriefTitle": "Dovitinib in Treating Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "Phase II Study of TKI258 (Dovitinib) in Patients With Recurrent or Progressive Glioblastoma Who Have Progressed With or Without Anti-Angiogenic Therapy (Including Anti-VEGF Therapy)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-12-20", "PrimaryCompletionDate": "2015-01-28", "Interventions": [ { "Name": "dovitinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CHIR-258", "receptor tyrosine kinase (RTK) inhibitor TKI258", "RTK inhibitor TKI258", "TKI258" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Manmeet Ahluwalia, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT01082926", "BriefTitle": "Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2", "OfficialTitle": "Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-05", "PrimaryCompletionDate": "2013-09", "Interventions": [ { "Name": "therapeutic allogeneic lymphocytes", "Type": "BIOLOGICAL", "Description": "Given intratumorally", "OtherNames": [ "ALLOLYMPH" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "aldesleukin", "Type": "BIOLOGICAL", "Description": "Given intratumorally", "OtherNames": [ "IL-2", "interleukin II", "Proleukin", "recombinant human interleukin-2", "recombinant interleukin-2", "TCGF, interleukin" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Optional correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "positron emission tomography", "Type": "PROCEDURE", "Description": "Optional correlative studies", "OtherNames": [ "FDG-PET", "PET", "PET scan", "tomography, emission computed" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03688178", "BriefTitle": "DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab", "OfficialTitle": "DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-08-26", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "Human CMV pp65-LAMP mRNA-pulsed autologous DCs", "Type": "BIOLOGICAL", "Description": "2x10\\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 4 (+ 2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1)", "OtherNames": [ "Temodar", "TMZ", "Temodal" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Varlilumab", "Type": "BIOLOGICAL", "Description": "Varlilumab is an agonist anti-CD27 monoclonal antibody", "OtherNames": [ "anti-CD27" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Td", "Type": "BIOLOGICAL", "Description": "A single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally", "OtherNames": [ "Tetanus-diphtheria (Td) toxoid", "Td pre-conditioning" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Unpulsed DCs", "Type": "BIOLOGICAL", "Description": "Patients in Group I will receive 1 x 10\\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.", "OtherNames": [ "Unpulsed DCs pre-conditioning" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Annick Desjardins, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Celldex Therapeutics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03332355", "BriefTitle": "Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2", "OfficialTitle": "(STM-03) Phase I Study of Procaspase Activating Compound-1 (PAC-1) in the Treatment of Advanced Malignancies - Component 2", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2017-10-01", "PrimaryCompletionDate": "2021-12-31", "Interventions": [ { "Name": "PAC-1 Compound", "Type": "DRUG", "Description": "PAC-1 in combination with temozolomide (Component 2): after the MTD is established for single agent PAC-1 in Component 1, a modified-Fibonacci dose-escalation 3+3 design starts in Component 2, at a PAC-1 dose one level lower than the MTD of PAC-1 established in the single agent PAC-1 component (i.e., Component 1). PAC-1 will be taken in the morning on days 1-21 in each 28 day cycle. Temozolomide 150 mg/m2 dose is given for the 5 days starting at day 8 of cycle 1 in cohorts of 3-6 patients. The combination cohort that reaches MTD will expanded to at least 9 patients, similar to the PAC-1 alone cohort at MTD.", "OtherNames": [ "Temozolamide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Vanquish Oncology, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "University of Illinois at Chicago" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03223103", "BriefTitle": "Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma", "OfficialTitle": "Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma (GCO 17-0566)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-03-01", "PrimaryCompletionDate": "2029-05-12", "Interventions": [ { "Name": "Poly-ICLC", "Type": "DRUG", "Description": "Poly-ICLC 100mcg per peptide per dose", "OtherNames": [ "Hiltonol®" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor Treating Fields", "Type": "DEVICE", "Description": "an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM", "OtherNames": [ "Optune®" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Peptides", "Type": "BIOLOGICAL", "Description": "synthetic long peptides (SLP) as vaccine substrate", "OtherNames": [ "Personalized peptides" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Adilia Hormigo", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04404569", "BriefTitle": "Continued Treatment for Participants Enrolled in Studies of BXQ-350", "OfficialTitle": "An Open-Label, Multi-Center, Rollover Study to Provide Continued Treatment Access for Participants Enrolled in Studies of BXQ-350", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2020-06-08", "PrimaryCompletionDate": "2024-09-23", "Interventions": [ { "Name": "BXQ-350", "Type": "DRUG", "Description": "BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion in 28-day cycles", "OtherNames": [ "SapC-DOPS" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Bexion Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "CTI Clinical Trial and Consulting Services" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05099068", "BriefTitle": "Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies (PLANET)", "OfficialTitle": "A Prospective Longitudinal Profiling Program of Cancer Patients With Sequential Tumor and Liquid Biopsies", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-11-16", "PrimaryCompletionDate": "2025-09-15", "Interventions": [ { "Name": "Blood and tumor samples", "Type": "BIOLOGICAL", "Description": "Longitudinal molecular profiling of tumor and liquid biopsies.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Leon Berard", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04988750", "BriefTitle": "Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients", "OfficialTitle": "An Open Label, Prospective, Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Combination of Focused Ultrasound With Re-irradiation for the Treatment Patients With Recurrent Glioblastoma Multiforme Using NaviFUS System", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-09-23", "PrimaryCompletionDate": "2024-10-31", "Interventions": [ { "Name": "NaviFUS System", "Type": "DEVICE", "Description": "Using the neuronavigator to precisely guide the ultrasound energy to brain tissues in real-time and intraoperatively.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NaviFUS Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01386710", "BriefTitle": "Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma", "OfficialTitle": "Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory Glioblastoma Multiforme And Anaplastic Astrocytoma", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-09", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Bevacizumab and Carboplatin", "Type": "DRUG", "Description": "Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier\n\nDay 28: Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until disease progression on MRI scan.\n\nIf progression occurs, repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until progression on MRI scan.\n\nRepeat Cycle", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab and Carboplatin", "Type": "DRUG", "Description": "Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier\n\nDay 28: No biweekly IV Bevacizumab plus Carboplatin treatment\n\nIf MRI shows progression then repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression Repeat Cycle", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04842513", "BriefTitle": "Multi Peptide Vaccination with XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma", "OfficialTitle": "Multi Peptide Vaccination with Pam3Cys-GDPKHPKSF (XS15) As an Immunomodulator in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed HLA-A2-positive MGMT-methylated Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2021-05-03", "PrimaryCompletionDate": "2024-07-31", "Interventions": [ { "Name": "Multipeptide plus XS15", "Type": "DRUG", "Description": "The vaccine will be applied by subcutaneous injection into the abdominal skin of the study patient. Vaccination will take place monthly (V1, V2 and V3). A total of three vaccinations will be performed. Peptide vaccines should be injected into the skin at the lower part of the abdomen of the patients. The exact site of vaccination (right or left) will be determined at the time of first vaccination and should not be changed during subsequent vaccinations.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital Tuebingen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06780592", "BriefTitle": "Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery", "OfficialTitle": "The Efficacy of Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery: a Study Protocol for a Prospective, Open-label ,Multi-center, Randomized, Controlled Trial in China", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-01-13", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Vebreltinib + Temozolomide", "Type": "DRUG", "Description": "Vebreltinib is a capsule in the form of 25 mg and 100mg, twice daily. Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Beijing Tiantan Hospital", "Beijing Sanbo Brain Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT06469138", "BriefTitle": "A Study to Investigate 14C-bemcentinib in Healthy Male Subjects", "OfficialTitle": "A Phase 1, Open-label, Nonrandomized Study to Investigate the Mass Balance Recovery and Metabolic Profile of 14C-bemcentinib Following Single Oral Administration in Healthy Male Subjects", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-08-02", "PrimaryCompletionDate": "2022-09-23", "Interventions": [ { "Name": "Bemcentinib", "Type": "DRUG", "Description": "Each 200 mg dose contains approximately 32.8 μCi (1.21 MBq) of 14C-bemcentinib and is administered as a single dose on Day 1 of the study.", "OtherNames": [ "BGB324" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "BerGenBio ASA", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02327078", "BriefTitle": "A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)", "OfficialTitle": "A Phase 1/2 Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-11-26", "PrimaryCompletionDate": "2020-06-16", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "specified dose and dosing schedule", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Epacadostat", "Type": "DRUG", "Description": "oral twice daily continuous at the protocol-defined dose", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Chemotherapy", "Type": "DRUG", "Description": "Specified dose on specified days", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Incyte Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT02302235", "BriefTitle": "Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study", "OfficialTitle": "Ketogenic Diet Treatment Adjunctive to Radiation and Chemotherapy in Glioblastoma Multiforme: a Pilot Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2021-12", "Interventions": [ { "Name": "Ketogenic Diet", "Type": "OTHER", "Description": "Treatment will consist of ketogenic diet. KD will consist of 4:1 \\[fat\\] : \\[protein+carbohydrate\\] weight ratio with 1600 kcal restriction.", "OtherNames": [ "KGD" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Standardized Diet", "Type": "OTHER", "Description": "Participants with GBM treated with radiation and temozolomide after surgical debulking treatment. The subjects will be taken standard diet in a 1:1 ratio. Diet will be started at the time of initiation of radiation treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Mid-Atlantic Epilepsy and Sleep Center, LLC", "LeadSponsorClass": "OTHER", "Collaborators": [ "Neuroscience Research Foundation, Sewickley,PA" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06894225", "BriefTitle": "Proof-of-Concept Study of ACT001 in Adult Patients With Recurrent Glioblastoma Harbouring STAT3-High Signature", "OfficialTitle": "Proof-of-Concept Study of ACT001 in Adult Patients With Recurrent Glioblastoma Harbouring STAT3-High Signature", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-04", "PrimaryCompletionDate": "2026-05", "Interventions": [ { "Name": "ACT001", "Type": "DRUG", "Description": "Patients recruited and have signed informed consent will be initiated on ACT001 400mg twice a day. Treatment course will repeat every 28 days in the absence of disease progression or unacceptable toxicity", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Neuroscience Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01091792", "BriefTitle": "Exploratory Study of the Modulation of the Immune System by VEGF Blockade in Patients With Glioblastoma Multiforme (GBM)", "OfficialTitle": "DMS 0947 Exploratory Study of the Modulation of the Immune System by Vascular Endothelial Growth Factor (VEGF) Blockade in Patients With Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2010-03", "PrimaryCompletionDate": "2015-04-02", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00114309", "BriefTitle": "131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma", "OfficialTitle": "A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2004-11", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "131-I-TM-601", "Type": "DRUG", "Description": "131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.", "OtherNames": [ "chlorotoxin" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "131I-TM601", "Type": "DRUG", "Description": "131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.", "OtherNames": [ "chlorotoxin" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "TransMolecular", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00031798", "BriefTitle": "Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors", "OfficialTitle": "A Phase III, Double-Blind, Prospective Randomized Clinical Trial of the Effect of D-threo-methylphenidate HCl (d-MPH) on Quality of Life in Brain Tumor Patients Receiving Radiation Therapy", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2002-04-01", "PrimaryCompletionDate": "2005-03-01", "Interventions": [ { "Name": "methylphenidate hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "quality-of-life assessment", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Wake Forest University Health Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01183663", "BriefTitle": "Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-Fluorouracil, Leucovorin, Oxaliplatin (FOLFOX)", "OfficialTitle": "A Phase I Study of Lenalidomide in Combination With Bevacizumab, Sorafenib, Temsirolimus, or 5-fluorouracil, Leucovorin, Oxaliplatin (FOLFOX) in Patients With Advanced Cancers", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2016-05", "Interventions": [ { "Name": "Lenalidomide", "Type": "DRUG", "Description": "Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.", "OtherNames": [ "CC-5013", "Revlimid" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.", "OtherNames": [ "Avastin", "Anti-VEGF monoclonal antibody", "rhuMAB-VEGF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Sorafenib", "Type": "DRUG", "Description": "Starting dose: 200 mg by mouth daily for 28 a day cycle.", "OtherNames": [ "Nexavar", "BAY 43-90006" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Temsirolimus", "Type": "DRUG", "Description": "Starting dose: 15 mg by vein every week for a 28 day cycle.", "OtherNames": [ "CC-779", "Torisel" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Lenalidomide", "Type": "DRUG", "Description": "Starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle.", "OtherNames": [ "CC-5013", "Revlimid" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Oxaliplatin", "Type": "DRUG", "Description": "Starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle.", "OtherNames": [ "Eloxatin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Leucovorin", "Type": "DRUG", "Description": "400 mg/m2 by vein on day 1 of a 21 day cycle.", "OtherNames": [ "Citrovorum", "Wellcovorin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "5-fluorouracil", "Type": "DRUG", "Description": "400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.", "OtherNames": [ "5-FU", "Adrucil", "Efudex" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Celgene" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02728349", "BriefTitle": "Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma", "OfficialTitle": "Phase 1 Trial of Tolerance and Pharmacokinetic of Chlorogenic Acid for Injection in the Advanced Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-04-12", "PrimaryCompletionDate": "2017-08-23", "Interventions": [ { "Name": "Chlorogenic acid", "Type": "DRUG", "Description": "Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sichuan J.Z. Bio-chemical Science and Technology Development Co., Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Beijing Shijitan Hospital, Capital Medical University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03277638", "BriefTitle": "Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM)", "OfficialTitle": "Phase I/II Study of Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-11-29", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "Pembrolizumab at 7 days prior", "Type": "DRUG", "Description": "Pembrolizumab injections 7 days before surgery", "OtherNames": [ "Pembrolizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Pembrolizumab at 14 days post", "Type": "DRUG", "Description": "Pembrolizumab injections 14 days after surgery", "OtherNames": [ "Pembrolizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Pembrolizumab at 35 days post", "Type": "DRUG", "Description": "Pembrolizumab injections 35 days after surgery", "OtherNames": [ "Pembrolizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Laser Interstitial Thermotherapy", "Type": "PROCEDURE", "Description": "surgical procedure to heat hard to reach tumors with a laser beam", "OtherNames": [ "LITT" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT02502708", "BriefTitle": "Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors", "OfficialTitle": "A Phase I Trial of Indoximod and Temozolomide-Based Therapy for Children With Progressive Primary Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-10", "PrimaryCompletionDate": "2019-12-12", "Interventions": [ { "Name": "Indoximod", "Type": "DRUG", "Description": "Indoximod will be administered orally twice daily.", "OtherNames": [ "1-methyl-D-tryptophan", "D-1MT" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered on days 1-5 of every 28 day cycle.", "OtherNames": [ "Temodar", "Methazolastone" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Conformal Radiation", "Type": "RADIATION", "Description": "Conformal radiation will be administered on days 3-7 of induction cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Cyclophosphamide will be administered orally daily.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Etoposide", "Type": "DRUG", "Description": "Etoposide will be administered orally daily.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NewLink Genetics Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05363826", "BriefTitle": "Intracavitary Photodynamic Therapy as an Adjuvant to Resection of Glioblastoma or Gliosarcoma Using IV Photobac®", "OfficialTitle": "Phase I Study of the Safety of Intracavitary Photodynamic Therapy (PDT) of the Brain Bordering Resected Recurrent Glioblastoma or Gliosarcoma Using Intravenous Photobac® and a Balloon Light Applicator", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-11", "PrimaryCompletionDate": "2025-05", "Interventions": [ { "Name": "photochemotherapy using 3-(1-Butyloxy)ethyl-3-deacetyl-bacteriopurpurin-18-n-butylimide methyl ester(Photobac®)", "Type": "COMBINATION_PRODUCT", "Description": "Intravenous injection of Photobac® 24 hours before surgical removal of recurrent GBMF.\n\nImmediately after resection, the cavity will be treated with 50 joules/ square cm of 787nm light. This treatment will add a maximum of 50 minutes to the surgery", "OtherNames": [ "Photobac® PDT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Photolitec LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Roswell Park Cancer Institute", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01922076", "BriefTitle": "Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas", "OfficialTitle": "A Phase 1 Study of AZD1775 (MK-1775) Concurrent With Local Radiation Therapy for the Treatment of Newly Diagnosed Children With Diffuse Intrinsic Pontine Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-09-03", "PrimaryCompletionDate": "2020-12-31", "Interventions": [ { "Name": "Adavosertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD-1775", "AZD1775", "MK-1775", "MK1775" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00612989", "BriefTitle": "Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM", "OfficialTitle": "Phase I Trial of a 5-day Regimen of Temodar Plus O6-Benzylguanine (O6-BG) in the Treatment of Patients With Recurrent / Progressive Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-02", "PrimaryCompletionDate": "2007-08", "Interventions": [ { "Name": "Temodar and O6-Benzylguanine", "Type": "DRUG", "Description": "O6-BG 120mg/m2 administered intravenously over 1 hr followed by continuous infusion of O6-BG at 30 mg/m2/day for 5 consecutive days. Every 48 hrs repeat dose of 120 mg/m2 over 1 hr administered for total of 3 doses.\n\nTemodar administered orally, in fasting state within 60 minutes of end of 1st 1-hr infusion of O6-BG \\& then every 24 hrs during continuous infusion of O6-BG. Temodar administered on day 1 of treatment cycle \\& every 24 hrs thereafter for 5 days with treatment cycles repeated every 28 days.\n\nPts must fast for minimum of 1 hr prior to administration of each dose of Temodar \\& continue fasting 2 hrs after administration of each Temodar dose.", "OtherNames": [ "Temodar", "Temozolomide", "O6-BG", "O6-Benzylguanine", "NSC637037", "Neulasta", "Pegfilgrastim" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough", "Keryx / AOI Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00253448", "BriefTitle": "Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Conventional Radiotherapy With Stereotactic Radiosurgery to High Risk Tumor Regions as Determined by Functional Imaging in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-12", "PrimaryCompletionDate": "2009-12", "Interventions": [ { "Name": "radiation therapy", "Type": "RADIATION", "Description": "No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "stereotactic radiosurgery", "Type": "RADIATION", "Description": "stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05380349", "BriefTitle": "Personalized Cancer Stem Cell High-Throughput Drug Screening for Glioblastoma", "OfficialTitle": "A Phase 1 Study of Combination Drug Therapy Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS) With Standard of Care for Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2024-04-19", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "combinations of up to 3 FDA approved drugs from a panel of compounds", "Type": "DRUG", "Description": "personalized drug combinations", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Swedish Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003478", "BriefTitle": "Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Primary Brain Tumors", "OfficialTitle": "Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1997-10", "PrimaryCompletionDate": "2007-07", "Interventions": [ { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 131 monoclonal antibody 81C6", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006358", "BriefTitle": "Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor", "OfficialTitle": "Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-06-13", "PrimaryCompletionDate": "2003-01-23", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "thalidomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03632135", "BriefTitle": "Standard Chemotherapy vs. Chemotherapy Guided by Cancer Stem Cell Test in Recurrent Glioblastoma", "OfficialTitle": "Standard Chemotherapy Versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients With Recurrent Glioblastoma Multiforme (GBM).", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2018-05-20", "PrimaryCompletionDate": "2022-06-16", "Interventions": [ { "Name": "ChemoID assay", "Type": "DIAGNOSTIC_TEST", "Description": "The ChemoID test is a CLIA-certified and CAP-accredited drug response assay performed by a hospital clinical pathology laboratory that uses a patient's live tumor cells to indicate which chemotherapy agent (or combinations) will kill not only bulk of tumor cells, but importantly the cancer stem cells (CSCs) that are known to cause cancer to recur. During the assay, cancer stem cells and bulk tumor cells from an individual patient are exposed to FDA-approved chemotherapy drugs.\n\nThe test measures the cytotoxic effect of actual doses of standard-of-care chemotherapies. The ChemoID drug response assay reports a prioritized list of effective and ineffective chemotherapies. The test is designed to target cancer stem cells to mitigate tumor relapse.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Chemotherapy", "Type": "DRUG", "Description": "Chemotherapies chosen by Physician or ChemoID assay are in the same list of FDA approved drugs to treat recurrent high-grade glioma", "OtherNames": [ "Cytotoxic chemotherapy drugs" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cordgenics, LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06222138", "BriefTitle": "Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma", "OfficialTitle": "Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-08-27", "PrimaryCompletionDate": "2028-05", "Interventions": [ { "Name": "The samples described below will be collected:", "Type": "OTHER", "Description": "For each included patient, blood samples will be collected during baseline visit (before initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months during TTFields treatment. Additional blood samples will be scheduled at recurrence (if applicable).\n\nMoreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples) will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case of recurrence, and if a second surgery is possible, tumor samples will also be collected.\n\nTumor samples will be collected from biopsies taken in the course of routine practice and from surgical specimens collected during surgical procedure.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04116658", "BriefTitle": "First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma", "OfficialTitle": "A Multicenter, Open-Label, First-in-Human, Phase 1b/2a Trial of EO2401, a Novel Multipeptide Therapeutic Vaccine, With and Without Check Point Inhibitor, Following Standard Treatment in Patients With Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-07-13", "PrimaryCompletionDate": "2024-03-04", "Interventions": [ { "Name": "Multiple dose of EO2401", "Type": "BIOLOGICAL", "Description": "Multiple dose administration of EO2401 coadministered with or without nivolumab (and bevacizumab, US only) during the priming phase", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Enterome", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Covance" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00980343", "BriefTitle": "GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery", "OfficialTitle": "A Biomarker and Phase II Study of GDC-0449 in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-02", "PrimaryCompletionDate": "2012-05", "Interventions": [ { "Name": "vismodegib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "Erivedge", "GDC-0449", "Hedgehog antagonist GDC-0449" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01740258", "BriefTitle": "Bevacizumab Beyond Progression (BBP)", "OfficialTitle": "Phase II Trial of Bevacizumab, Radiation Therapy and Temodar Followed by Bevacizumab and Temodar With Continuation of Bevacizumab Beyond Progression (BBP-Bevacizumab Beyond Progression)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-01", "PrimaryCompletionDate": "2019-11-14", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "XRT" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "temo", "temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": null, "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00002647", "BriefTitle": "Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors", "OfficialTitle": "Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "1994-05", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "verteporfin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical College of Wisconsin", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01906385", "BriefTitle": "Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)", "OfficialTitle": "A Dual Phase 1/2, Investigator Initiated Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of 186Rhenium Nanoliposomes (186RNL) in Recurrent Glioma (CTRC# 12-02)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-06-03", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Rhenium Liposome Treatment", "Type": "DRUG", "Description": "At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the CED catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.", "OtherNames": [ "Rhenium-186 NanoLiposome" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Plus Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05120284", "BriefTitle": "Trial of Dichloroacetate (DCA) in Glioblastoma Multiforme (GBM)", "OfficialTitle": "Trial of Dichloroacetate (DCA) in Glioblastoma Multiforme (GBM)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-07-01", "PrimaryCompletionDate": "2026-07-01", "Interventions": [ { "Name": "Dichloroacetate (DCA)", "Type": "DRUG", "Description": "Study medication DCA is a liquid formulation mixed with an artificial sweetener containing aspartame and strawberry extract (50mg/mL)\n\nParticipants will be genotyped to determine GSTZ1 (glutathione S-transferase Zeta-1) haplotype status, which will stratify this group into 1 of 2 dose regimens:\n\nEGT carriers will receive 12-14 mg/kg/12hr DCA. EGT non-carriers will receive 6-7 mg/kg/12 hr.", "OtherNames": [ "Sodium Dichloroacetate" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Genotype", "Type": "GENETIC", "Description": "Participants will be genotyped to determine GSTZ1 haplotype status.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00650949", "BriefTitle": "Efficacy Study of CYT997 in Combination With Carboplatin in Glioblastoma", "OfficialTitle": "A Phase Ib/II Study of CYT997 in Combination With Carboplatin in Relapsed Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-11", "PrimaryCompletionDate": "2011-06", "Interventions": [ { "Name": "CYT997", "Type": "DRUG", "Description": "Escalating doses (100mg/m\\^2 to 150mg/m\\^2), 24-hour intravenous infusion on Day 2 of a 21-day cycle (Phase Ib component). Dose selected in Phase Ib component to be used for Phase II component.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Intravenous infusion over 1 hour at area under the concentration-time curve (AUC)=5 on Day 1 of a 21-day cycle", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Gilead Sciences", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05267106", "BriefTitle": "Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations", "OfficialTitle": "A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2022-05-20", "PrimaryCompletionDate": "2024-12-17", "Interventions": [ { "Name": "Pemigatinib", "Type": "DRUG", "Description": "13.5mg tablet taken every morning (unless otherwise directed) for 2 weeks and then 1 week off.", "OtherNames": [ "NCB054828" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Incyte Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03776071", "BriefTitle": "A Trial of Enzastaurin Plus Temozolomide During and Following Radiation Therapy in Patients With Newly Diagnosed Glioblastoma With or Without the Novel Genomic Biomarker, DGM1", "OfficialTitle": "A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Enzastaurin Added to Temozolomide During and Following Radiation Therapy in Newly Diagnosed Glioblastoma Patients Who Possess the Novel Genomic Biomarker DGM1", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2020-12-16", "PrimaryCompletionDate": "2024-02-29", "Interventions": [ { "Name": "Enzastaurin Hydrochloride", "Type": "DRUG", "Description": "mg", "OtherNames": [ "Kinenza" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "mg", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "mg/m\\^2", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Gy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Denovo Biopharma LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00727506", "BriefTitle": "BIBW 2992 (Afatinib) With or Without Daily Temozolomide in the Treatment of Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I/II Trial of BIBW 2992 (Afatinib) in Treating Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-07-14", "PrimaryCompletionDate": "2011-05-12", "Interventions": [ { "Name": "BIBW 2992", "Type": "DRUG", "Description": "BIBW 2992 once daily", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "TMZ", "Type": "DRUG", "Description": "TMZ 21/28", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "BIBW 2992 plus TMZ", "Type": "DRUG", "Description": "BIBW 2992 once daily plus TMZ 21/28 days", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Boehringer Ingelheim", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00028678", "BriefTitle": "Dalteparin and Radiation Therapy in Treating Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study to Evaluate the Effect of Dalteparin and Radiation Therapy on Survival Compared to the RTOG RPA Database and on Thromboembolic Events in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2002-07-11", "PrimaryCompletionDate": "2006-07", "Interventions": [ { "Name": "dalteparin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Eastern Cooperative Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01752491", "BriefTitle": "A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme", "OfficialTitle": "A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-04-01", "PrimaryCompletionDate": "2015-11-30", "Interventions": [ { "Name": "Ascorbate", "Type": "DRUG", "Description": "Intravenous infusion of high-dose ascorbate", "OtherNames": [ "Ascorbic Acid", "Vitamin C" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Oral chemotherapeutic", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "External beam radiation therapy", "OtherNames": [ "External beam radiation therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Joseph J. Cullen, MD, FACS", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01967758", "BriefTitle": "Phase I Study of Safety and Immunogenicity of ADU-623", "OfficialTitle": "Phase I Study of Safety and Immunogenicity of ADU-623, a Live-attenuated Listeria Monocytogenes Strain (ΔactA/ΔinlB) Expressing the EGFRvIII-NY-ESO-1 Vaccine, in Patients With Treated and Recurrent WHO Grade III/IV Astrocytomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-01-08", "PrimaryCompletionDate": "2018-06-18", "Interventions": [ { "Name": "Cohort 1", "Type": "BIOLOGICAL", "Description": "Four doses of IV ADU-623 at a dose of 3 x 10\\^7cfu", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Cohort 2", "Type": "BIOLOGICAL", "Description": "Four doses of IV ADU-623 at a dose of 3 x 10\\^8cfu", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Cohort 3", "Type": "BIOLOGICAL", "Description": "Four doses of IV ADU-623 at a dose of 3 x 10\\^9cfu", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Antibiotics", "Type": "DRUG", "Description": "A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole at 12 hour intervals) will be initiated for each patient 3 days following each dose of ADU-623. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.", "OtherNames": [ "Amoxicillin", "Augmentin", "trimethoprim / sulfamethoxazole", "Bactrim" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [] } } ], "LeadSponsorName": "Providence Health & Services", "LeadSponsorClass": "OTHER", "Collaborators": [ "Aduro Biotech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [] } }, { "NCTId": "NCT00003185", "BriefTitle": "Biological Therapy in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "Adoptive Immunotherapy of Glioblastoma Multiforme With Tumor-Sensitized, Ex Vivo Activated T Lymphocytes", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1997-08", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "autologous tumor cell vaccine", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "tumor-draining lymph node lymphocyte therapy", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "cyclophosphamide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The Cleveland Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00345163", "BriefTitle": "A Study to Evaluate Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme (BRAIN)", "OfficialTitle": "A Phase II, Multicenter, Randomized, Non-Comparative Clinical Trial to Evaluate the Efficacy and Safety of Bevacizumab Alone or in Combination With Irinotecan for Treatment of Glioblastoma Multiforme in First or Second Relapse", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-07", "PrimaryCompletionDate": "2007-09", "Interventions": [ { "Name": "bevacizumab", "Type": "DRUG", "Description": "Intravenous repeating dose", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "irinotecan", "Type": "DRUG", "Description": "Intravenous repeating dose", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Genentech, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04547621", "BriefTitle": "HSRT and IMRT Chemoradiotherapy for Newly Diagnosed GBM", "OfficialTitle": "The Combination of Hypofractionated Stereotactic Radiotherapy and Chemoradiotherapy Using Intensity-Modulated Radiotherapy for Newly Diagnosed Glioblastoma Multiforme: A Prospective, Single-Center, Single-Arm Phase II Clinical Trial", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-09-01", "PrimaryCompletionDate": "2023-01-01", "Interventions": [ { "Name": "Radiation", "Type": "DEVICE", "Description": "Intensity-modulated radiotherapy 20Gy/10fx", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation", "Type": "DEVICE", "Description": "Hypofractionated Stereotactic Radiotherapy 30Gy/5fx", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide 75 mg/m2 concurrently administered with RT.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06910306", "BriefTitle": "A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-10-01", "PrimaryCompletionDate": "2026-11-01", "Interventions": [ { "Name": "Device :DaRT seeds", "Type": "DEVICE", "Description": "The sources are impregnated with a layer containing Ra-224 which is well fixated to the surface of the source. Ra-224 undergoes a series of decay events with each daughter product producing an alpha particle", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alpha Tau Medical LTD.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02619864", "BriefTitle": "mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Previously Treated Glioblastoma Multiforme", "OfficialTitle": "A Phase I Study of the mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Patients With Previously Treated Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-12-22", "PrimaryCompletionDate": "2019-03-22", "Interventions": [ { "Name": "AZD2014", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Canadian Cancer Trials Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03250299", "BriefTitle": "Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I Study to Determine the Safety and Tolerability of the Oral Microtubule Destabilizer BAL101553 in Combination With Standard Radiation in Patients With MGMT Promoter Unmethylated Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2017-12-15", "PrimaryCompletionDate": "2022-06-03", "Interventions": [ { "Name": "Microtubule-Targeted Agent BAL101553", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BAL101553, Microtubule-targeted Agent BAL101553" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy, Irradiate, irradiated, irradiation, RADIATION, Radiation, radiation therapy, Radiation Therapy, Radiotherapeutics, radiotherapy, Radiotherapy, RT, Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Basilea Pharmaceutica", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT04223999", "BriefTitle": "Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)", "OfficialTitle": "Enhancing Tumor Treating Fields for Recurrent Glioblastoma With Targeted and Individualised Skullremodeling Surgery: A Multi-center Randomized Phase 2 Trial", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-10-01", "PrimaryCompletionDate": "2024-03-01", "Interventions": [ { "Name": "Skullremodeling surgery", "Type": "PROCEDURE", "Description": "Strategically placed cranial burrholes in order to improve the TTField \"dose\" focally in the tumor.", "OtherNames": [ "SR-surgery" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Control", "Type": "OTHER", "Description": "Tumor treating fields combined with best medical treatment.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Anders Rosendal Korshøj", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure GmbH", "Odense University Hospital", "Aalborg University Hospital", "Rigshospitalet, Denmark" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06917885", "BriefTitle": "CUE-102 in Recurrent Glioblastoma", "OfficialTitle": "Phase Ib Open-label Study of Adjuvant CUE-102, a WT-1-pHLA-IL2-Fc Fusion Protein in Glioblastoma (GBM) Patients at First Recurrence", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-30", "PrimaryCompletionDate": "2026-01-31", "Interventions": [ { "Name": "CUE-102", "Type": "BIOLOGICAL", "Description": "A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "David Reardon, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cue Biopharma" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06719440", "BriefTitle": "Achieving a Better Outcome Through Limiting the Glioblastoma Clinical Target Volume", "OfficialTitle": "Impact of Reducing the Irradiation Volume on Survival, Toxicity, and Quality of Life in Patients With Glioblastoma Treated With Radiochemotherapy: a Prospective Multicenter Randomised Study", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-05-12", "PrimaryCompletionDate": "2031-10", "Interventions": [ { "Name": "Radiotherapy (CTV=10mm)", "Type": "RADIATION", "Description": "Radiotherapy with reduced irradiation volume CTV=10mm", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiotherapy (CTV=15mm)", "Type": "RADIATION", "Description": "Radiotherapy with standard irradiation volume CTV=15mm", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cliniques universitaires Saint-Luc- Université Catholique de Louvain", "LeadSponsorClass": "OTHER", "Collaborators": [ "Belgium Health Care Knowledge Centre" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04908176", "BriefTitle": "A Drug-drug Interaction Study of Avapritinib and Midazolam", "OfficialTitle": "A Drug-drug Interaction Study to Investigate the Effect of Avapritinib on the Pharmacokinetics of Midazolam in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) and Other Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-08-24", "PrimaryCompletionDate": "2024-03-01", "Interventions": [ { "Name": "Avapritinib", "Type": "DRUG", "Description": "avapritinib tablets", "OtherNames": [ "BLU-285" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "midazolam", "Type": "DRUG", "Description": "midazolam syrup", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Blueprint Medicines Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02465268", "BriefTitle": "Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "ATTAC-II: A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-08-09", "PrimaryCompletionDate": "2023-11-30", "Interventions": [ { "Name": "pp65-shLAMP DC with GM-CSF", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [ "pp65-shLAMP mRNA DCs with GM-CSF" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "unpulsed PBMC and saline", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [ "Peripheral Blood Mononuclear Cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Td", "Type": "DRUG", "Description": "All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.", "OtherNames": [ "Tetanus and Diphtheria Toxoid" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Saline", "Type": "DRUG", "Description": null, "OtherNames": [ "Normal Saline" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pp65-flLAMP DC with GM-CSF", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [ "pp65-flLAMP mRNA DCs with GM-CSF" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003410", "BriefTitle": "Motexafin Gadolinium With MRI-Guided Surgery in Treating Patients With High-Grade Gliomas", "OfficialTitle": "Pilot Trial of Gadolium Texaphyrin for Magnetic Resonance Imaging-Guided Resection of High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1998-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03973918", "BriefTitle": "Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG", "OfficialTitle": "A Phase II Study of Binimetinib in Combination With Encorafenib in Adults With Recurrent BRAF V600-Mutated High-Grade Astrocytoma or Other Primary Brain Tumor", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2019-07-29", "PrimaryCompletionDate": "2022-04-30", "Interventions": [ { "Name": "Encorafenib", "Type": "DRUG", "Description": "450mg QD 28 day cycle", "OtherNames": [ "Braftovi" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Binimetinib", "Type": "DRUG", "Description": "45mg BID 28 day cycle", "OtherNames": [ "Mektovi" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Research Bloods", "Type": "BIOLOGICAL", "Description": "Baseline; pre-cycle 3; Pre-cycle 7; off Treatment", "OtherNames": [ "Circulating Tumor DNA" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "BRAF", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Tumor Tissue", "Type": "BIOLOGICAL", "Description": "at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01110876", "BriefTitle": "Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "Phase I / II Adaptive Randomized Trial of Vorinostat, Erlotinib and Temozolomide in Adults With Recurrent Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-06", "PrimaryCompletionDate": "2014-07", "Interventions": [ { "Name": "Vorinostat", "Type": "DRUG", "Description": "Phase I Starting Dose: 200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle.\n\nPhase II Dose: MTD from Phase I.", "OtherNames": [ "SAHA", "Suberoylanilide Hydroxamic Acid", "MSK-390", "Zolinza" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Erlotinib", "Type": "DRUG", "Description": "Phase I Starting Dose: 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg.\n\nPhase II Dose: MTD from Phase I.", "OtherNames": [ "Erlotinib Hydrochloride", "OSI-774", "Tarceva" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00553150", "BriefTitle": "Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-03", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "everolimus", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06271421", "BriefTitle": "NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme", "OfficialTitle": "Application of Nanoparticles for Cyclic Hyperthermia In Adjuvant Therapy of gLioblastoma Multiforme (ANCHIALE)", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-01-01", "PrimaryCompletionDate": "2027-02-01", "Interventions": [ { "Name": "NanoTherm therapy", "Type": "DEVICE", "Description": "Cyclic hyperthermia in patients with recurrent glioblastoma multiforme, who underwent implantation of iron oxide nanoparticles.", "OtherNames": [ "Cyclic hyperthermia" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Glioma Resection", "Type": "PROCEDURE", "Description": "Removal of brain tumor - gross total ressection", "OtherNames": [ "Surgical removal of Glioma tumor" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiotherapy according to Stupp protocol", "Type": "RADIATION", "Description": "The total dose according to the Stupp protocol is 60 Gy and is administered in fractions of 2 Gy per day for 5 days (Monday to Friday) for 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "chemotherapy according to Stupp protocol", "Type": "DRUG", "Description": "Temozolomide is used during radiotherapy: 75 mg/m2 of body surface area per day for 7 days a week. After the completion of radiotherapy, temozolomide is used as adjuvant therapy - 6 cycles of 150-200 mg/m2 of body surface area for 5 days every 28 days.", "OtherNames": [ "temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Poznan University of Medical Sciences", "LeadSponsorClass": "OTHER", "Collaborators": [ "MagForce USA" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06964815", "BriefTitle": "Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients", "OfficialTitle": "Silibinin in Association With Concomitant Chemoradiotherapy and Maintenance Temozolomide in STAT3 Positive IDH Wild-type, Newly Diagnosed Glioblastoma Patients: a Multicenter, Double-blind, Placebo-controlled, Randomized Study", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-11-12", "PrimaryCompletionDate": "2027-10", "Interventions": [ { "Name": "Silibinin as STAT3 inhibitor", "Type": "DIETARY_SUPPLEMENT", "Description": "Sillbrain will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Each 3.7 g sachet of Sillbrain contains 500 mg silibinin. Every patient will assume 2 sachets/day for a total of 1 g/day of silibinin.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "Placebo will be available as granulate in sachets of 3.7g and it will be administered twice a day during chemo-radiotherapy and day 1-28 in maintenance phase every cycle. Every patient will assume 2 sachets/day for a total of 1 g/day of placebo.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Istituto Oncologico Veneto IRCCS", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04188535", "BriefTitle": "Serial MRI Scans During Radiation Therapy", "OfficialTitle": "RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-01-15", "PrimaryCompletionDate": "2030-07-31", "Interventions": [ { "Name": "MRI IMAGING", "Type": "DIAGNOSTIC_TEST", "Description": "Imaging with MRI will be performed as per disease site standards.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05653635", "BriefTitle": "Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study", "OfficialTitle": "Contribution From PET-DOPA in Glioblastoma Re-irradiation - A Randomized Phase II Study", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-09-01", "PrimaryCompletionDate": "2028-09-01", "Interventions": [ { "Name": "Simultaneous-integrated boost with IMRT", "Type": "RADIATION", "Description": "Simultaneous-integrated boost guided by FDOPA-PET", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut de cancérologie Strasbourg Europe", "LeadSponsorClass": "OTHER", "Collaborators": [ "Centre Georges François Leclerc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00099125", "BriefTitle": "Radiation Therapy, Temozolomide, and Irinotecan in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2004-11", "PrimaryCompletionDate": "2006-10", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03291314", "BriefTitle": "Clinical Trial on the Combination of Avelumab and Axitinib for the Treatment of Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase II Clinical Trial on the Combination of Avelumab and Axitinib for the Treatment of Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-05-03", "PrimaryCompletionDate": "2019-01-01", "Interventions": [ { "Name": "Axitinib", "Type": "DRUG", "Description": "1\\. Axitinib, a VEGFR-specific small molecule tyrosine kinase inhibitor (Tki) has demonstrated anti-tumor activity when evaluated as a mono-therapy and in combination with lomustine for the treatment of patients with recGB (EudraCT 2011-000900-16) \\[7\\].", "OtherNames": [ "InlytaTM" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "PD-L1", "VEGF" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Avelumab", "Type": "DRUG", "Description": "2\\. Avelumab (MSB00107; anti-PD-L1) is a fully human anti-PD-L1 IgG1 monoclonal antibody (mAb) that has demonstrated anti-tumor activity in several tumor types.", "OtherNames": [ "MSB00107" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1" ], "classes": [ "Checkpoint inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Universitair Ziekenhuis Brussel", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "PD-L1", "VEGF" ], "classes": [ "Alkylating agent", "Checkpoint inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT01251484", "BriefTitle": "BIBF 1120 in Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of BIBF 1120 in Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-01", "PrimaryCompletionDate": "2012-08", "Interventions": [ { "Name": "BIBF1120", "Type": "DRUG", "Description": "Tablet 200 mg twice daily until progression", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ulrik Lassen", "LeadSponsorClass": "OTHER", "Collaborators": [ "Boehringer Ingelheim", "University of Copenhagen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03008148", "BriefTitle": "Phase II/III Trial of CCRT With or Without JP001 for Newly Diagnosed GBM", "OfficialTitle": "Randomized Phase II/III Trial of Radiotherapy Plus Concomitant and Adjuvant Temozolomide With or Without Hydroxychloroquine, Rapamycin for Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2018-10-11", "PrimaryCompletionDate": "2025-04", "Interventions": [ { "Name": "CCRT", "Type": "RADIATION", "Description": "CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles.", "OtherNames": [ "Chemotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Siroquine", "Type": "DRUG", "Description": "1. Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle).\n2. Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed.", "OtherNames": [ "JP001" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Johnpro Biotech, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01846871", "BriefTitle": "Tivozanib for Recurrent Glioblastoma", "OfficialTitle": "A Phase II Study of Tivozanib in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2013-06", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Tivozanib", "Type": "DRUG", "Description": null, "OtherNames": [ "AV-951" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Comprehensive Cancer Network" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03160599", "BriefTitle": "Restricted Calorie Ketogenic Diet as a Treatment in Malignant Tumors", "OfficialTitle": "Restricted Calorie Ketogenic Diet as a Treatment in Glioblastoma Multiforme: a Clinical Study", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2018-03-01", "PrimaryCompletionDate": "2019-12-01", "Interventions": [ { "Name": "ketogenic diet", "Type": "OTHER", "Description": "The treatment is mainly restricted calorie ketogenic diet. KD will consist of 4:1-1:1\\[fat\\]:\\[protein+carbohydrate\\].Carbohydrate is limited to 10-30 g / day.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Second Affiliated Hospital of Guangzhou Medical University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02766699", "BriefTitle": "A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent GBM", "OfficialTitle": "A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of EGFR (Vectibix® Sequence)-Targeted EnGeneIC Dream Vectors Containing Doxorubicin (EGFR(V)-EDV-Dox) in Subjects With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-10-25", "PrimaryCompletionDate": "2021-08-21", "Interventions": [ { "Name": "EGFR(V)-EDV-Dox", "Type": "DRUG", "Description": "EGFR(V)-EDV-Dox using EnGeneIC EDV™ technology is a bacterially derived minicell which packages a toxic payload, Doxorubicin, into a 400 nm particle which targets specific cancer cells using bispecific antibodies (BsAb). BsAb-targeted, payload-packaged EDV nanocells only exit the leaky blood vessels associated with tumors and enter into the tumor microenvironment. The BsAb binds to the tumor cell-surface receptor, where the EDV is taken up, broken down within the cancer cell and releases the Doxorubicin. The residual EDVs that do not make it into the tumor microenvironment, are engulfed by cells of the immune system and since the EDVs are derived from bacteria, they carry potent immuno-stimulating components which appear to bypass the immuno-suppression caused by the tumor.", "OtherNames": [ "EnGeneIC Dream Vector™", "EnGeneIC Delivery Vehicle™" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Engeneic Pty Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Johns Hopkins University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT05896449", "BriefTitle": "Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin", "OfficialTitle": "Predictive Values of Preoperative [68Ga]Ga-PSMA-11 PET/CT in Patients With Suspected Brain Tumours of Glial Origin", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2020-06-01", "PrimaryCompletionDate": "2022-07-11", "Interventions": [ { "Name": "[68Ga]Ga-PSMA-11 PET/CT", "Type": "DIAGNOSTIC_TEST", "Description": "The PET/CT image acquisition was performed from the skull to the mid-thigh (3-min per bed position, 3 iterations, 21 subsets) with a CT scan (120 kV, 170mAs reference) with dose modulation for anatomic correlation (CARE dose 4D) and attenuation correction on a Biograph 64 TruePoint (Siemens Medical Solutions Inc., USA) 60 min post injection of \\[68Ga\\]Ga-PSMA-11 (2 MBq per kg body weight).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Medical University of Warsaw", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05474378", "BriefTitle": "B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-07-12", "PrimaryCompletionDate": "2026-08", "Interventions": [ { "Name": "B7-H3CART", "Type": "DRUG", "Description": "B7-H3CART will be administered administered locoregionally (either ICV or both ICV and intratumorally (IT)) at one of the following doses:\n\nDose Level -1: 5 x 10\\^6 CAR+ cells (+/- 20%) Dose Level 1: 10 x 10\\^6 CAR+ cells (+/- 20%) Dose Level 2: 25 x 10\\^6 CAR+ cells (+/- 20%) Dose Level 3: 50 x 10\\^6 CAR+ cells (+/- 20%) Dose Level 4: 100 x 10\\^6 CAR+ cells (+/- 20%)\n\nB7-H3CART Dose Dose Level -1 (DL-1): 5 x 106 B7-H3CART+ cells (± 20%) Dose Level 1 (DL 1): 10 x 106 B7-H3CART+ cells (± 20%) Dose Level 2 (DL2): 25 x 106 B7-H3CART+ cells (± 20%) Dose Level 3 (DL3): 50 x 106 B7-H3CART+ cells (± 20%) Dose Level 4 (DL4): 100 x 106 B7-H3CART+ cells (± 20%)\n\nRepeated every 28 days (-7 / +14 days) as long as infusion criteria are met for a total of 6 doses, with an option for an additional 6 doses, up to a total of 12.", "OtherNames": [ "B7H3-CAR T" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [ "California Institute for Regenerative Medicine (CIRM)", "Parker Institute for Cancer Immunotherapy" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06773481", "BriefTitle": "BC008-1A Injection for Recurrent CNS WHO G4 Glioma", "OfficialTitle": "A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-04-07", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "BC008-1A", "Type": "BIOLOGICAL", "Description": "Biological: 900 mg BC008-1A will be intravenously injected once every 3 weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "BC008-1A", "Type": "BIOLOGICAL", "Description": "Biological: 1200 mg BC008-1A will be intravenously injected once every 3 weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Beijing Tiantan Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05186064", "BriefTitle": "Glioblastoma Targeted Treatment Option Maximization by WGS", "OfficialTitle": "Glioblastoma Targeted Treatment Option Maximization by Whole Genome Sequencing", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-07-25", "PrimaryCompletionDate": "2024-07-01", "Interventions": [ { "Name": "whole genome sequencing", "Type": "DIAGNOSTIC_TEST", "Description": "whole genome sequencing will be performed on tumor material after re-resection per standard of care", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "UMC Utrecht", "LeadSponsorClass": "OTHER", "Collaborators": [ "Amsterdam University Medical Center", "The Netherlands Cancer Institute", "The Elisabeth-TweeSteden Hospital", "Erasmus Medical Center", "Medical Center Haaglanden", "Isala", "Leiden University Medical Center", "Maastricht University Medical Center", "Medisch Spectrum Twente", "Radboud University Medical Center", "University Medical Center Groningen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01514201", "BriefTitle": "Veliparib, Radiation Therapy, and Temozolomide in Treating Younger Patients With Newly Diagnosed Diffuse Pontine Gliomas", "OfficialTitle": "A Phase I/II Study of ABT-888, An Oral Poly(ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children With Newly Diagnosed Diffuse Pontine Gliomas (DIPG)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-02-01", "PrimaryCompletionDate": "2018-03-28", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3D-CRT", "OtherNames": [ "3-dimensional radiation therapy", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo IMRT", "OtherNames": [ "IMRT", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Optional correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Veliparib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ABT-888", "PARP-1 inhibitor ABT-888" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PARP" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05879367", "BriefTitle": "Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma", "OfficialTitle": "An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-07-24", "PrimaryCompletionDate": "2026-06-30", "Interventions": [ { "Name": "Eflornithine (Dose Level 1)", "Type": "DRUG", "Description": "Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule", "OtherNames": [ "DFMO" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Eflornithine (Dose Level 2)", "Type": "DRUG", "Description": "Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule", "OtherNames": [ "DFMO" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Eflornithine (Dose Level -1)", "Type": "DRUG", "Description": "Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule", "OtherNames": [ "DFMO" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Orbus Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07225621", "BriefTitle": "Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma", "OfficialTitle": "Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial Comparing Standard of Care Adjuvant Temozolomide With or Without 5-Aminolevulinic Acid (5-ALA) With Concomitant Low Intensity Diffuse Ultrasound (LIDU) Sonodynamic Therapy (SDT) System In Patients With Newly Diagnosed Glioblastoma After Completion of Chemoradiotherapy", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2026-01", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "5-ALA HCl + LIDU SDT", "Type": "COMBINATION_PRODUCT", "Description": "standard of care temozolomide + sonosenitizer + sonodynamic therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo + Sham SDT", "Type": "COMBINATION_PRODUCT", "Description": "standard of care temozolomide + placebo + sham sonodynamic therapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Alpheus Medical, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03128047", "BriefTitle": "HUMC 1612: Optune NovoTTF-200A System", "OfficialTitle": "HUMC 1612: A Phase I Trial of the Optune NovoTTF-200A System With Concomitant Temozolomide and Bevacizumab in Pediatric Patients With High-grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-04-06", "PrimaryCompletionDate": "2024-07-08", "Interventions": [ { "Name": "Optune NovoTTF-200A System", "Type": "DEVICE", "Description": "Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Hackensack Meridian Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01836549", "BriefTitle": "Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors", "OfficialTitle": "A Molecular Biology and Phase II Study of Imetelstat (GRN163L) in Children With Recurrent High-Grade Glioma, Ependymoma and Diffuse Intrinsic Pontine Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2013-03", "PrimaryCompletionDate": "2016-04", "Interventions": [ { "Name": "imetelstat sodium", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "GRN163L", "telomerase inhibitor GRN163L" ], "modality": [ "Other" ], "moa": { "targets": [ "MET", "TERT" ], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET", "TERT" ], "classes": [] } }, { "NCTId": "NCT00430079", "BriefTitle": "Use of EF5 to Measure the Oxygen Level in Tumor Cells of Patients Undergoing Surgery or Biopsy for Newly Diagnosed Supratentorial Malignant Glioma", "OfficialTitle": "Assessment of Hypoxia in Malignant Gliomas Using EF5", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2001-07", "PrimaryCompletionDate": "2007-09", "Interventions": [ { "Name": "etanidazole", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "2-nitro-imidazole derivative", "SR-2508" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [ "surgery, conventional" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00052455", "BriefTitle": "Temozolomide Compared to Procarbazine, Lomustine, and Vincristine in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Prospective Randomised Trial Comparing Temozolomide With PCV In The Treatment Of Recurrent WHO Astrocytic Tumours Grades III And IV", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2002-10", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "lomustine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "procarbazine hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Institute of Cancer Research, United Kingdom", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01189240", "BriefTitle": "RO4929097and Bevacizumab in Treating Patients With Progressive or Recurrent Malignant Glioma", "OfficialTitle": "Phase I/II Study of R04929097 With Bevacizumab in Patients With Recurrent Malignant Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2013-01", "Interventions": [ { "Name": "gamma-secretase/Notch signalling pathway inhibitor RO4929097", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "R4733", "RO4929097" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "Avastin", "rhuMAb VEGF" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04421378", "BriefTitle": "A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma", "OfficialTitle": "A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-06-08", "PrimaryCompletionDate": "2023-07-03", "Interventions": [ { "Name": "Selinexor", "Type": "DRUG", "Description": "Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral", "OtherNames": [ "KPT-330", "XPOVIO" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine (CCNU)", "Type": "DRUG", "Description": "Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard Fractionated Radiation therapy (RT)", "Type": "RADIATION", "Description": "Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "TTField", "Type": "DEVICE", "Description": "Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carmustine", "Type": "DRUG", "Description": "Dose and Formulation: 150 or 200 mg/m\\^2; Route of Administration: Intravenous", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Karyopharm Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01048008", "BriefTitle": "Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer", "OfficialTitle": "A Protocol for the Safety and Tolerance of Intravenous 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-09", "PrimaryCompletionDate": "2013-07", "Interventions": [ { "Name": "DM-CHOC-PEN", "Type": "DRUG", "Description": "DM-CHOC-PEN will be dosed @ 39 mg/M2, escalated in 1-patient cohorts at 40% dosage.\n\nAt the 1st DLT - expand to 3-6 patient cohorts/dose with escalations at 33% increments.\n\nThe MTD will be where 2 DLTs are noted and the study is discontinued.", "OtherNames": [ "4-Demethylcholesteryloxycarbonylpenclomedine" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "DEKK-TEC, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01331291", "BriefTitle": "Bosutinib in Adult Patients With Recurrent Glioblastoma", "OfficialTitle": "An Open Label, Phase 2 Trial of Orally Administered Bosutinib (SKI-606) in Adult Patients With Recurrent Glioblastoma (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-04", "PrimaryCompletionDate": "2014-12", "Interventions": [ { "Name": "bosutinib", "Type": "DRUG", "Description": "Taken orally", "OtherNames": [ "SKI-606" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Dana-Farber Cancer Institute", "Brigham and Women's Hospital", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00083447", "BriefTitle": "Study of Therapy With TransMID™ Compared to Best Standard of Care in Patients With Glioblastoma Multiforme", "OfficialTitle": "A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE3" ], "StartDate": "2004-05", "PrimaryCompletionDate": "2006-03", "Interventions": [ { "Name": "TransMID™", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Xenova Biomedix", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00278278", "BriefTitle": "Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas", "OfficialTitle": "Treatment of Children and Adolescents With Diffuse Intrinsic Pontine Glioma and High Grade Glioma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2003-09", "PrimaryCompletionDate": "2010-03", "Interventions": [ { "Name": "cisplatin", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "etoposide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "ifosfamide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "lomustine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "methotrexate", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "prednisone", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "German Society for Pediatric Oncology and Hematology GPOH gGmbH", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07195591", "BriefTitle": "Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care", "OfficialTitle": "Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-12-10", "PrimaryCompletionDate": "2031-12", "Interventions": [ { "Name": "GammaTile®", "Type": "DEVICE", "Description": "GammaTiles are a U.S. FDA-cleared, surgically targeted radiation therapy for patients with certain brain tumors. GammaTile consists of bioresorbable collagen tiles embedded with Cesium-131 (Cs-131) radioactive seeds", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "External Beam Radiation Therapy", "Type": "RADIATION", "Description": "External beam radiation therapy (EBRT) is a type of radiation therapy that is standard of care. EBRT uses a machine outside the body to deliver high-energy beams of radiation to cancerous areas within the body", "OtherNames": [ "EBRT" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "TMZ (Chemotherapy) is used as a first-line treatment, often in combination with radiation therapy after surgical resection of the tumor", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "GT Medical Technologies, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06353360", "BriefTitle": "TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.", "OfficialTitle": "Tumor-Treating Fields (TTFields) in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma: A Safety and Efficacy Clinical Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-04-30", "PrimaryCompletionDate": "2025-07-15", "Interventions": [ { "Name": "Tumor Treating Fields", "Type": "DEVICE", "Description": "Tumor Treating Fields will be administered continuously with a planned ≥ 18 h per day, starting on the Day 1 of cycle 1 (C1D1), throughout the entire course of treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Tislelizumab", "Type": "DRUG", "Description": "Tislelizumab will be given 300 mg intravenously every 4 weeks beginning on Day 1 of Cycle 2 of adjuvant TMZ. The Tislelizumab treatment should be continued until confirmed PD, unacceptable toxicity, or finished Tislelizumab treatment for other reasons.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "The patients will carry out 6 cycles of TMZ adjuvant chemotherapy according to the instructions. The dosage of TMZ is 150-200 mg/(m2·d), daily for 5 days followed by 23 days without treatment, the treatment cycle is 28 days. The initial dose of cycle 1 is 150 mg/(m2·d), if patients do not experience TMZ chemotherapy toxicity, the dose should be increased to 200 mg/(m2·d) in subsequent treatment cycles. After 6 cycles of TMZ adjuvant chemotherapy, if the patients do not experience disease progression, it is recommended to continue TMZ adjuvant chemotherapy, or treated according to investigators' recommendations. The TMZ treatment should be continued until confirmed progressive disease (PD), unacceptable toxicity, or finished TMZ treatment for other reasons.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jiangsu Healthy Life Innovation Medical Technology Co., Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03347617", "BriefTitle": "Ferumoxytol MRI in Assessing Response to Pembrolizumab in Patients With Glioblastoma", "OfficialTitle": "Response Assessment to Pembrolizumab With Standard of Care Therapy in Glioblastoma Using Ferumoxytol Steady State Imaging- A Pilot Study", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2017-12-20", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "Ferumoxytol", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Feraheme", "Ferumoxytol Non-Stoichiometric Magnetite" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo ferumoxytol MRI", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Keytruda", "Lambrolizumab", "MK-3475", "SCH 900475" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "OHSU Knight Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Oregon Health and Science University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT03152318", "BriefTitle": "A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2", "OfficialTitle": "A Phase I Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2, a Genetically Engineered HSV-1 Virus, and Immunomodulation With Cyclophosphamide", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2017-07-18", "PrimaryCompletionDate": "2026-01", "Interventions": [ { "Name": "rQNestin", "Type": "DRUG", "Description": "rQNestin is an oncolytic viral vector. It is administered via intratumoral injection during biopsy surgery.", "OtherNames": [ "rQNestin34.5v.2", "CAN-3110" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Cyclophosphamide is an immunomodulating agent. It is administered intravenously in a single dose 2 days (+/- 6 hrs) before surgery.", "OtherNames": [ "Cytoxan®", "Neosar®" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic biopsy", "Type": "PROCEDURE", "Description": "In both arms, subjects will undergo standard of care stereotactic biopsy in the intraoperative MRI operating room. The stereotactic needle will be placed stereotactically into the tumor bed using intraoperative MRI guidance to collect the biopsy, and again to administer the rQNestin oncolytic virus.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)", "Candel Therapeutics, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04790097", "BriefTitle": "FET-PET Directed Simultaneous In-field Boost for Primary GBM", "OfficialTitle": "Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-02-21", "PrimaryCompletionDate": "2019-12-30", "Interventions": [ { "Name": "Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost", "Type": "RADIATION", "Description": "78Gy in 30 fractions on FET-PET based target volumes;\n\n60Gy in 30 fractions on 2cm margin from MRI based target volumes;\n\nall patients will be treated with concomitant and adjuvant temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Prof. Franciszek Lukaszczyk Memorial Oncology Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06359379", "BriefTitle": "Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter", "OfficialTitle": "Phase 2 Study of Ropidoxuridine as a Radiation Sensitizing Agent During Radiotherapy in Patients With Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2024-09-02", "PrimaryCompletionDate": "2025-12-01", "Interventions": [ { "Name": "Ropidoxuridine", "Type": "DRUG", "Description": "Ropidoxuridine is administered daily, 5 days a week, for 7 weeks, starting one week prior to radiotherapy, and then concurrently with a standard 60 Gy radiotherapy, followed by a 4-week rest period.", "OtherNames": [ "5-iodo-2-pyrimidinone-2'-deoxyribose" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Shuttle Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH", "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT00074646", "BriefTitle": "Phase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas", "OfficialTitle": "Phase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2003-12", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "CC-8490", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Celgene Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04105374", "BriefTitle": "Testing the Addition of an Anti-cancer Viral Gene Therapy, Toca 511/Toca FC, to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II/III Randomized, Open-Label Study of Toca 511, A Retroviral Replicating Vector, Combined With Toca FC With Temozolomide and Radiation Followed by Adjuvant Temozolomide and Toca FC Compared to Temozolomide and Radiation Followed by Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2020-01-31", "PrimaryCompletionDate": "2025-11-30", "Interventions": [ { "Name": "Extended Release Flucytosine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Extended Release 5-FC", "Extended Release 5-Fluorocytosine", "Extended-Release 5-FC", "Extended-Release 5-Fluorocytosine", "Extended-Release Flucytosine", "Toca FC" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "NovoTTF-100A Device", "Type": "DEVICE", "Description": "Receive Optune device", "OtherNames": [ "NovoTTF-100A", "NovoTTF-100A System", "NovoTTFields", "NovoTumor Treatment Fields", "Optune", "Optune Device" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "Irradiated", "irradiation", "Radiation", "Radiotherapeutics", "RADIOTHERAPY", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo standard of care surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Vocimagene Amiretrorepvec", "Type": "BIOLOGICAL", "Description": "Given via intracranial injection", "OtherNames": [ "DNA (Synthetic Toca 511-encoding Retroviral Vector AC3-yCD2(V))", "Toca 511" ], "modality": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NRG Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02296580", "BriefTitle": "A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Feasibility Study of the Nativis Voyager® System in Patients With Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2021-09-30", "Interventions": [ { "Name": "Nativis Voyager RFE Therapy", "Type": "DEVICE", "Description": "Nativis Voyager Radiofrequency Energy Therapy", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Nativis, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00083096", "BriefTitle": "Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas", "OfficialTitle": "Phase I Study Of SCH66336 (Lonafarnib), A Farnesyl Protein Transferase Inhibitor In Combination With Temozolomide In Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2004-03", "PrimaryCompletionDate": "2009-06", "Interventions": [ { "Name": "lonafarnib", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03665545", "BriefTitle": "Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma", "OfficialTitle": "Pembrolizumab in Association With the Multipeptide Vaccine IMA950 Adjuvanted With Poly-ICLC for Relapsing Glioblastoma: a Randomized Phase I/ II Trial", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-10-25", "PrimaryCompletionDate": "2023-12-31", "Interventions": [ { "Name": "IMA950/Poly-ICLC", "Type": "DRUG", "Description": "IMA950 mixed with Poly-ICLC administered subcutaneously", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "IMA950/Poly-ICLC and pembrolizumab", "Type": "DRUG", "Description": "IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University Hospital, Geneva", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT00792012", "BriefTitle": "A Dose Per Fraction Escalation Trial of Hypofractionated IMRT With Temozolomide for Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I Dose Per Fraction Escalation Study of Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) Combining With Temozolomide (TMZ) Chemotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-11", "PrimaryCompletionDate": "2016-07", "Interventions": [ { "Name": "Hypofractionated Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "All patients will receive one fraction of radiation therapy a day, 5 days a week, Monday through Friday. Radiation fraction size and number of fractions depend on dose fraction level the patient is assigned to.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be administered orally, once a day starting on the first day of radiation, for 28 consecutive days during radiation, and after radiation for those patients completing radiation in less than 28 days.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Colorado, Denver", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04559230", "BriefTitle": "Sacituzumab Govitecan in Recurrent Glioblastoma", "OfficialTitle": "A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-01-06", "PrimaryCompletionDate": "2026-02", "Interventions": [ { "Name": "Sacituzumab Govitecan", "Type": "DRUG", "Description": "Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The University of Texas Health Science Center at San Antonio", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00897611", "BriefTitle": "Tumor DNA and MRI/CT Scan Findings in Patients With Grade III or Grade IV Malignant Glioma", "OfficialTitle": "Identification of Hypermethylated Serum Tumor DNA in High Grade Glioma Patients and Correlation With Magnetic Resonance Imaging Findings", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2005-04", "PrimaryCompletionDate": "2009-08", "Interventions": [ { "Name": "DNA methylation analysis", "Type": "PROCEDURE", "Description": null, "OtherNames": [ "blood collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [ "Epigenetic modifier" ] } }, { "Name": "polymerase chain reaction", "Type": "PROCEDURE", "Description": null, "OtherNames": [ "blood collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "computed tomography", "Type": "PROCEDURE", "Description": null, "OtherNames": [ "CT scan" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [ "MRI scan" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "North American Brain Tumor Consortium" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": null, "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Epigenetic modifier" ] } }, { "NCTId": "NCT00227032", "BriefTitle": "Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme", "OfficialTitle": "Phase I Study of Erlotinib Administered Every 72 Hours in Patients With Glioblastoma Multiforme With Pharmacokinetic/Pharmacodynamic Correlates", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2005-09", "PrimaryCompletionDate": "2008-02", "Interventions": [ { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "300 mg, per day for subjects taking EIAEDs\n\n150 mg, per day for those NOT taking EIAEDs", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "UNC Lineberger Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00038493", "BriefTitle": "Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Evaluation Temozolomide and Farnesyl Transferase Inhibitor (SCH66336) for the Treatment of Recurrent and Progressive Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2001-09-21", "PrimaryCompletionDate": "2005-08-01", "Interventions": [ { "Name": "Temozolomide and SCH66336", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04516733", "BriefTitle": "Precoce Medical Care by the Mobil Support for Patients With Glioblastoma", "OfficialTitle": "Precoce Medical Care by the Mobil Support for Patients With Glioblastoma Receiving Specific Medical Oncology Treatment", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-05-10", "PrimaryCompletionDate": "2020-09-15", "Interventions": [ { "Name": "supportive care", "Type": "OTHER", "Description": "visit with supportiv unit and neuropsychologue every 3 months", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut du Cancer de Montpellier - Val d'Aurelle", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04808245", "BriefTitle": "A MultIceNTER Phase I Peptide VaCcine Trial for the Treatment of H3-Mutated Gliomas", "OfficialTitle": "A MultIceNTER Phase I Peptide VaCcine Trial to Exploit NeoePitope-Specific T Cells for the Treatment of H3-Mutated Gliomas - (INTERCEPT-H3)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-02-15", "PrimaryCompletionDate": "2026-11", "Interventions": [ { "Name": "Tecentriq 1200 MG in 20 ML Injection", "Type": "DRUG", "Description": "One vial of Tecentriq® (1200 mg) will be administered as an intravenous (i.v.) infusion over 60 minutes every 3 weeks starting 4 weeks after radiotherapy. If the first infusion is tolerated, all subsequent infusions will be delivered over 30 minutes.", "OtherNames": [ "Atezolizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "H3K27M peptide vaccine", "Type": "BIOLOGICAL", "Description": "The H3K27M peptide vaccine is injected subcutaneously (s.c.). For a single vaccination 300 μg of the peptide will be emulsified in a total volume of 1 ml.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Imiquimod (5%)", "Type": "OTHER", "Description": "One sachet of Aldara® cream (250 mg) will be applied to an area of 5 x 5 cm around the injection site of the H3K27M peptide vaccine 15 min after vaccination and left on the skin for approximately 8 hours according to the instructions in the SmPC. 24 hours after the vaccination a second sachet of Aldara® will be applied by the patient as instructed above and left on the skin for approximately 8 hours.", "OtherNames": [ "Aldara" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "German Cancer Research Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Johannes Gutenberg University Mainz", "Charite University, Berlin, Germany", "Roche Pharma AG", "German Cancer Aid" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT02576665", "BriefTitle": "A Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma (Toca 6)", "OfficialTitle": "A Phase 1b Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Patients With Solid Tumors or Lymphoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2016-07", "PrimaryCompletionDate": "2019-05", "Interventions": [ { "Name": "Toca 511", "Type": "BIOLOGICAL", "Description": "Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-fluorocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector", "OtherNames": [ "vocimagene amiretrorepvec", "RRV", "retroviral replicating viral" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Toca FC", "Type": "DRUG", "Description": "Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with \"TOCA FC\" embossed on one side and \"500\" embossed on the other side", "OtherNames": [ "Flucytosine", "5-FC", "5-Fluorocytosine" ], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Tocagen Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03393000", "BriefTitle": "Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects", "OfficialTitle": "Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate With Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2018-01-16", "PrimaryCompletionDate": "2020-11-06", "Interventions": [ { "Name": "Trans Sodium Crocetinate plus SOC", "Type": "DRUG", "Description": "Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide", "OtherNames": [ "Trans Sodium Crocetinate (TSC) plus Standard of Care" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard of Care (SOC)", "Type": "OTHER", "Description": "Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide", "OtherNames": [ "Standard of Care" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Diffusion Pharmaceuticals Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01402063", "BriefTitle": "PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation", "OfficialTitle": "PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation: A Randomized Phase II Study", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-09", "PrimaryCompletionDate": "2014-04", "Interventions": [ { "Name": "PPX (CT2103)", "Type": "DRUG", "Description": "XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Brown University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Rhode Island Hospital", "Milton S. Hershey Medical Center", "University of Washington", "University of Massachusetts, Worcester", "MaineHealth", "University of California, San Diego", "Thomas Jefferson University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07326566", "BriefTitle": "Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII", "OfficialTitle": "A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2026-04", "PrimaryCompletionDate": "2028-11", "Interventions": [ { "Name": "silevertinib in combination with temozolomide", "Type": "DRUG", "Description": "Participants enrolled into Part 1 (Safety Lead-In) or randomized to Arm A in Part 2 will receive silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles.", "OtherNames": [ "BDTX-1535", "Temodar", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "temozolomide (TMZ)", "Type": "DRUG", "Description": "Participants randomized to Arm B will receive temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles", "OtherNames": [ "TMZ", "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Black Diamond Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT01392209", "BriefTitle": "Hypofractionated Stereotactic Radiotherapy With Bevacizumab in the Treatment of Recurrent Malignant Glioma", "OfficialTitle": "A PHASE I DOSE ESCALATION STUDY OF HYPOFRACTIONATED STEREOTACTIC RADIOTHERAPY WITH BEVACIZUMAB IN THE TREATMENT OF RECURRENT MALIGNANT GLIOMA", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-07-08", "PrimaryCompletionDate": "2019-11-15", "Interventions": [ { "Name": "Bevacizumab & Stereotactic Radiotherapy", "Type": "OTHER", "Description": "Treatment: (until treatment failure): bevacizumab 10 mg/kg IV once every two weeks on days 1 (+/- 3 days) and 15 (+/- 3 days) of every cycle (Cycle defined as 28 days). On day 28 (or up to 2 days before) of cycles 1 and 2 (and for every other cycle thereafter) patients will undergo a physical and radiological re-evaluation (MRI). Patients will begin stereotactic radiotherapy beginning anywhere from day 7 to day 10 of cycle 2 with escalating fraction sizes (interpatient - there is no intrapatient escalation). Assessment of response will be performed following cycles 1 and 2 then following every two cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "Columbia University", "University of California, San Francisco" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04190628", "BriefTitle": "Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors", "OfficialTitle": "A Phase I, First-In-Human, Multicenter, Open-Label Dose Escalation and Dose Expansion Study of ABM-1310, as a Monotherapy and a Combination Therapy, Administered Orally in Adult Patients With Advanced Solid Tumors Harboring BRAF Mutations", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2020-06-16", "PrimaryCompletionDate": "2024-04-05", "Interventions": [ { "Name": "ABM-1310", "Type": "DRUG", "Description": "Part A: Starting dose at 25 mg by mouth twice daily.\n\nPart B: Starting dose at a dose below the MTD( Maximum Tolerated Dose) that has been demonstrated to be safe in Part A.\n\nPart C-1 and C-2: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part A until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.\n\nPart C-3 and C-4: Continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part B until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.", "OtherNames": [ "ABM1310" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "BRAF", "MET" ], "classes": [] } }, { "Name": "Cobimetinib", "Type": "DRUG", "Description": "Part B: orally administered once daily.\n\nPart C-3 and C-4: Continuous once daily oral dose from Part B, administered the first 21 days of each 28-day treatment cycle until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.\n\nDose formulation is 60 mg capsules.", "OtherNames": [ "Cotellic®" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "ABM Therapeutics Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "BRAF", "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01549392", "BriefTitle": "Imaging Study of Glioblastomas Treated With Avastin", "OfficialTitle": "Feasibility Study of Magnetic Resonance Spectroscopy and Dynamic Enhanced Cat Scan Imaging in Glioblastomas Treated With and Without Avastin", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2012-02", "PrimaryCompletionDate": "2014-03", "Interventions": [ { "Name": "DECT", "Type": "DEVICE", "Description": "DECT at tumor progression and 3 months later", "OtherNames": [ "3 T 64-slice CT scanner (Discovery CT750 HD, GE Healthcare" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "MR spectroscopy", "Type": "DEVICE", "Description": "MR spectroscopy at tumor progression and 3 months later", "OtherNames": [ "MRI scanner: Siemens 3T Tim Trio", "Sequences: T1W, DTI", "Analysis software: Brain voyager" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "London Health Sciences Centre", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Western Ontario, Canada", "London Regional Cancer Program, Canada" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04712721", "BriefTitle": "Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.", "OfficialTitle": "Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-10-14", "PrimaryCompletionDate": "2024-06-18", "Interventions": [ { "Name": "68Ga-FF58", "Type": "DRUG", "Description": "Single intravenous radiolabeled gallium FF58 injection determined by body weight (3 Megabecquerel (MBq)/Kg (+/- 10%)). Administered dose must not be lower than 150 MBq or higher than 250 MBq.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03732352", "BriefTitle": "18F-FDG PET and Osimertinib in Evaluating Glucose Utilization in Patients with EGFR Activated Recurrent Glioblastoma", "OfficialTitle": "Creating Metabolic Vulnerabilities in Patients with EGFR Activated Recurrent Glioblastoma by Inhibiting EGFR with Osimertinib", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-11-28", "PrimaryCompletionDate": "2024-01-31", "Interventions": [ { "Name": "Fludeoxyglucose F-18", "Type": "OTHER", "Description": "Given IV", "OtherNames": [ "18FDG", "FDG", "fludeoxyglucose F 18", "Fludeoxyglucose F18", "Fluorine-18 2-Fluoro-2-deoxy-D-Glucose", "Fluorodeoxyglucose F18" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Osimertinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD-9291", "AZD9291", "Mereletinib", "Tagrisso" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo fludeoxyglucose F-18 PET scan", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03596086", "BriefTitle": "HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM", "OfficialTitle": "Phase I-II Study Evaluating HSV-tk + Valacyclovir Gene Therapy Combination with Radiotherapy and Chemotherapy for Recurrent Glioblastoma Multiforme", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-12-11", "PrimaryCompletionDate": "2025-12-30", "Interventions": [ { "Name": "ADV/HSV-tk (gene therapy)", "Type": "DRUG", "Description": "The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy", "OtherNames": [ "gene transfer, gene therapy", "HSV-tk" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "David Baskin MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Center for Cell and Gene Therapy, Baylor College of Medicine", "The Methodist Hospital Research Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00621686", "BriefTitle": "Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase II Trial of Bevacizumab in Combination With Sorafenib in Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-09", "PrimaryCompletionDate": "2010-10", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "sorafenib tosylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02441322", "BriefTitle": "Evaluating Therapeutic Response to Novo-TTF", "OfficialTitle": "High Resolution MRI and MRS to Evaluate Therapeutic Response to Novo-TTF in Newly and Recurrent Glioblastomas", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2014-12", "PrimaryCompletionDate": "2023-06", "Interventions": [ { "Name": "Novo-TTF", "Type": "DEVICE", "Description": "Procedures: MRI and advanced MRI sequence Advanced brain MRI's with special sequences will be obtained. First MRI prior to starting Novo-TTF therapy, second MRI up to 2-3 weeks after beginning therapy, third MRI up to 2 months from starting treatment and the last MRI up to 4 months after starting treatment.", "OtherNames": [ "Optune" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02893137", "BriefTitle": "Enhancing Optune Therapy With Targeted Craniectomy", "OfficialTitle": "Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-10-01", "PrimaryCompletionDate": "2019-05-31", "Interventions": [ { "Name": "Optune", "Type": "DEVICE", "Description": "For further information see www.optune.com", "OtherNames": [ "NovoTTF-100A", "Tumor treating fields", "TTFields" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Craniectomy", "Type": "PROCEDURE", "Description": "A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Aarhus University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00003457", "BriefTitle": "Antineoplaston Therapy in Treating Patients With Brain Tumors", "OfficialTitle": "Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Brain Tumors.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1996-07", "PrimaryCompletionDate": "2012-02", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06279767", "BriefTitle": "Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma", "OfficialTitle": "Efficacy and Safety of TMZ Plus 6-MP in the Patients With Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-07-01", "PrimaryCompletionDate": "2025-07-01", "Interventions": [ { "Name": "6-mercaptopurine", "Type": "DRUG", "Description": "6-mercaptopurine (6-MP) is a crucial drug in the maintenance phase of acute lymphoblastic leukemia treatment.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "The First Affiliated Hospital with Nanjing Medical University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01378481", "BriefTitle": "High-Dose Vorinostat and Fractionated Stereotactic Body Radiation Therapy in Treating Patients With Recurrent Glioma", "OfficialTitle": "High-Dose Vorinostat With Radiation Therapy in the Treatment of Recurrent Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2012-06", "PrimaryCompletionDate": "2013-08", "Interventions": [ { "Name": "Vorinostat", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "L-001079038", "SAHA", "Suberanilohydroxamic Acid", "Suberoylanilide Hydroxamic Acid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic Radiosurgery", "Type": "RADIATION", "Description": "Undergo fractionated stereotactic radiation therapy", "OtherNames": [ "SBRT", "Stereotactic External Beam Irradiation", "Stereotactic Radiation Therapy", "Stereotactic Radiotherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo neurosurgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01987830", "BriefTitle": "Bevacizumab w / Temozolomide PET & Vascular MRI For GBM", "OfficialTitle": "A Study to Evaluate Vascular Normalization in Patients With Recurrent Glioblastoma Treated With Bevacizumab Using [11C]Temozolomide PET and Vascular MRI", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-11", "PrimaryCompletionDate": "2019-04", "Interventions": [ { "Name": "MRI-PET", "Type": "DEVICE", "Description": "* \\[11C\\] temozolomide for PET scan and a contrast dye for the MRI scan\n* Drawing blood to assess the radioactivity of \\[11C\\] temozolomide", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "TMZ-PET", "Type": "DEVICE", "Description": "The PET scan will take approximately 90 minutes. You will receive one injection of \\[11C\\] temozolomide. Following the injection of the radioactive substance, blood samples will be taken from the second IV line.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Massachusetts General Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05512195", "BriefTitle": "Safety and Efficacy of a New Approach to Delineating Clinical Target Volume of Glioblastoma", "OfficialTitle": "Safety and Efficacy of a New Approach to Delineating Clinical Target Volume by Referencing the Nerve Fiber Bundles for Radiotherapy of Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2022-09-01", "PrimaryCompletionDate": "2024-09-01", "Interventions": [ { "Name": "New delineation approach", "Type": "RADIATION", "Description": "New delineation approach", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Zhongnan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03452930", "BriefTitle": "Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastoma", "OfficialTitle": "A Phase I Study to Investigate the Safety, Pharmacokinetic Profile and the Efficacy of EDO-S101, a First-in-Class Alkylating HDACi Fusion Molecule in Patients With Newly Di-Agnosed MGMT-Promoter Unmethylated Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-08-13", "PrimaryCompletionDate": "2024-06-05", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo RT", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Tinostamustine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "1H-Benzimidazole-2-heptanamide, 5-(Bis(2-chloroethyl)amino)-N-hydroxy-1-methyl-", "EDO-S 101", "EDO-S-101", "EDO-S101" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "ALK", "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02795364", "BriefTitle": "Study About the Validity of MRS-guided Resection on Prognosis High-grade Glioma Gliomas", "OfficialTitle": "A Prospective Study About the Validity of MRS-guided Resection on Prognosis High-grade Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2016-06", "PrimaryCompletionDate": "2017-05", "Interventions": [ { "Name": "Structural Image Guidance", "Type": "PROCEDURE", "Description": "Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Metabolic Image Guidance", "Type": "PROCEDURE", "Description": "Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03423628", "BriefTitle": "A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer", "OfficialTitle": "A Phase I, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD1390 in Combination With Radiation Therapy in Patients With Glioblastoma Multiforme and Brain Metastases From Solid Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-04-02", "PrimaryCompletionDate": "2026-09-16", "Interventions": [ { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "35 Gy of Intensity-modulated radiation therapy (IMRT) administered at daily fractions of 3.5 Gy over 10 fractions (2 weeks)", "OtherNames": [ "Radiotherapy", "Radiation treatment", "RT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "AZD1390", "Type": "DRUG", "Description": "AZD1390 Administered in 3 Cycles depending on arm:\n\nCycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 2 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. For optional food effect assessment in Arm A, 2 doses prior to RT under both fed and fasted conditions. Note: the food effect assessment is currently open to recruitment.\n\nArm A includes the Japan part following the same dosing administration.", "OtherNames": [ "ATM inhibitor" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "30 Gy of whole brain radiation therapy (WBRT) or partial brain radiation therapy (PBRT) administered at daily fractions of 3 Gy over 10 fractions (2 weeks).", "OtherNames": [ "Radiotherapy", "Radiation treatment", "RT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "60 Gy of intensity- modulated radiation therapy (IMRT) administered at daily fractions of 2 Gy over 30 fractions (6 weeks)", "OtherNames": [ "Radiotherapy", "Radiation treatment", "RT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "AZD1390", "Type": "DRUG", "Description": "AZD1390 administered in 1 Cycle. AZD1390 administration concomitantly with RT (2 weeks). Cycle 1 also contains an additional 5 days (post completion of RT with AZD1390 administration). Arm is Closed.", "OtherNames": [ "ATM inhibitor" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "AZD1390", "Type": "DRUG", "Description": "AZD1390 Administered in 3 Cycles depending on arm:\n\nCycle 0: 1 dose prior to Radiation Therapy. Cycle 1: 6 weeks Intermittent or continuous dosing during Radiation Therapy. Cycle 2: 2 weeks adjuvant treatment after Radiation Therapy. Arm is closed.", "OtherNames": [ "ATM inhibitor" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "AstraZeneca", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03050736", "BriefTitle": "Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT Expression", "OfficialTitle": "An Open Label Trial of Dianhydrogalactitol (VAL-083) and Radiation Therapy in Treatment of Newly Diagnosed GBM Patients With An Unmethylated Promoter of the Methylguanine-DNA Methyltransferase (MGMT) Gene", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-12-17", "PrimaryCompletionDate": "2021-11-22", "Interventions": [ { "Name": "VAL-083 (Dianhydrogalactitol)", "Type": "DRUG", "Description": "VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Kintara Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Sun Yat-sen University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT00074334", "BriefTitle": "TP-38 Toxin in Treating Young Patients With Recurrent or Progressive Supratentorial High-Grade Glioma", "OfficialTitle": "A Phase I/II Study Of A Recombinant Chimeric Protein Composed Of Transforming Growth Factor (TGF)-a And A Mutated Pseudomonas Exotoxin Termed PE38 (TP-38) In Pediatric Patients With Recurrent Or Progressive Supratentorial High Grade Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2004-05", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "TGFa-PE38 immunotoxin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05990244", "BriefTitle": "Magnetic Resonance Elastography in Glioma: Exploring Tumor Stiffness and Adhesion", "OfficialTitle": "Comprehensive Assessment of Tumor Stiffness and Adhesion in Glioma Using Magnetic Resonance Elastography: A Prospective Study", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2017-01-01", "PrimaryCompletionDate": "2026-07-01", "Interventions": [ { "Name": "Magnetic Resonance Elastography", "Type": "DIAGNOSTIC_TEST", "Description": "Undergo MRE and routine MRI", "OtherNames": [ "MRE" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Assessment and Recording", "Type": "PROCEDURE", "Description": "Undergo recording of tumor stiffness during surgery and molecular pathological classification through genetic analysis", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shengjing Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06650605", "BriefTitle": "Phase 1 Open-label Study of 123I-ATT001 in Subjects with Relapsed Glioblastoma", "OfficialTitle": "Citadel-123: a Phase I Clinical Trial to Assess the Activity of I-123 Poly Adenosine Diphosphate Ribose Polymerase I Inhibitor (123I-ATT001) Directly Administered in Subjects with Relapsed Glioblastoma.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-07-04", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "123I-ATT001", "Type": "DRUG", "Description": "123I-ATT001", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Theragnostics Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05608395", "BriefTitle": "11C-methionine in Diagnostics and Management of Glioblastoma Multiforme Patients (GlioMET)", "OfficialTitle": "11C-methionine in Diagnostics and Management of Glioblastoma Multiforme With Rapid Early Progression Patients Prior to Adjuvant Oncological Therapy (GlioMET)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-12-04", "PrimaryCompletionDate": "2024-06-20", "Interventions": [ { "Name": "11C-Methionine PET/CT", "Type": "DRUG", "Description": "11C-Methionine PET/CT will be applied in patients in 11C-Methionine PET/CT Arm, based on planning MRI, prior chemo/radiotherapy (2 weeks prior C1D1)", "OtherNames": [ "Methionine application" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Masaryk Memorial Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02575027", "BriefTitle": "Palliative 4pi Radiotherapy in Treating Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "4π Radiotherapy for Recurrent Glioblastoma Multiforme: A Feasibility Trial", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2014-11-12", "PrimaryCompletionDate": "2018-06-20", "Interventions": [ { "Name": "Palliative Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 4pi palliative radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy Treatment Planning and Simulation", "Type": "RADIATION", "Description": "Undergo 4pi radiation simulation and planning", "OtherNames": [ "Radiation Therapy Treatment Planning/Simulation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06585527", "BriefTitle": "Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma", "OfficialTitle": "A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-08-29", "PrimaryCompletionDate": "2026-01-01", "Interventions": [ { "Name": "TS-2021", "Type": "BIOLOGICAL", "Description": "The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Neurosurgical Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04623931", "BriefTitle": "Chemotherapy and Radiation Therapy for the Treatment of IDH Wildtype Gliomas or Non-histological (Molecular) Glioblastomas", "OfficialTitle": "Phase II Trial of Treatment Intensification for IDH Wildtype, Non-Histological Glioblastoma, Gliomas (IDH Wildtype Lower Grade Glioma Treatment Intensification)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-01-30", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00379470", "BriefTitle": "Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2006-09", "PrimaryCompletionDate": "2009-11", "Interventions": [ { "Name": "NovoTTF-100A", "Type": "DEVICE", "Description": "multiple four-week courses of continuous NovoTTF-100A treatment", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NovoCure Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004073", "BriefTitle": "Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Suramin and Concurrent Radiation Therapy in Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-12", "PrimaryCompletionDate": "2003-05", "Interventions": [ { "Name": "suramin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00363272", "BriefTitle": "Ispinesib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Lymphoma", "OfficialTitle": "A PHASE 1 STUDY OF ISPINESIB (SB-715992) IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY SOLID TUMORS", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-06", "PrimaryCompletionDate": "2008-10", "Interventions": [ { "Name": "ispinesib", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CK0238273", "SB-715992" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04704154", "BriefTitle": "A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors", "OfficialTitle": "A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2021-02-03", "PrimaryCompletionDate": "2023-03-09", "Interventions": [ { "Name": "Regorafenib, (Stivarga, BAY73-4506)", "Type": "DRUG", "Description": "Intake orally, starting with 3x 30 mg tablets every day (once daily.) for 21 days of every 28-day cycle (21 days on, 7 days off).\n\nIf the starting dose is well tolerated dose can be escalated to 120 mg (4x30 mg tablets).", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab (Opdivo)", "Type": "DRUG", "Description": "480 mg administered on Day 1 of each treatment cycle.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Bayer", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Bristol Myers Squibb Co. and Ono Pharmaceutical Co., Ltd" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT07343986", "BriefTitle": "Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma", "OfficialTitle": "Phase I Clinical Trial of Anti-CD3 × Anti-EGFR Bispecific-armed T Cells (EGFR BATs) and Low-Intensity Focused Ultrasound (LIFU) Blood-brain Barrier Opening in Patients With MGMT Unmethylated Glioblastoma (GBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2026-01", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "anti-EGFR bispecific-armed T cells", "Type": "DRUG", "Description": "IN PROGRESS", "OtherNames": [ "EGFR BATs" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [] } }, { "Name": "Low-Intensity Focused Ultrasound", "Type": "DEVICE", "Description": "Low-Intensity Focused Ultrasound will be used to open the blood-brain barrier", "OtherNames": [ "LIFU" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "University of Virginia", "LeadSponsorClass": "OTHER", "Collaborators": [ "Focused Ultrasound Foundation", "NaviFUS Corporation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR", "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT01435395", "BriefTitle": "Trial of Temozolomide, Bevacizumab Plus Bortezomib for Recurrent Glioblastoma Multiforme", "OfficialTitle": "Phase I Trial of Temozolomide, Bevacizumab Plus Bortezomib for Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-12", "PrimaryCompletionDate": "2016-04", "Interventions": [ { "Name": "Temozolomide, bevacizumab and bortezomib", "Type": "DRUG", "Description": "Escalating temozolomide with standard dose bevacizumab and bortezomib", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Schering-Plough", "Genentech, Inc.", "Millennium Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03506139", "BriefTitle": "Biologically-based Target Volumes to Treat Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2019-05-15", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "External beam radiation therapy", "Type": "RADIATION", "Description": "Radiotherapy to 75 Gy Radiation delivered 1 fraction / day, Monday through Friday, for a total of 30 fractions", "OtherNames": [ "radiotherapy", "radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "John M. Buatti", "LeadSponsorClass": "OTHER", "Collaborators": [ "Holden Comprehensive Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04588454", "BriefTitle": "18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme", "OfficialTitle": "18F-PSMA PET/CT for Visualization of Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2020-01-17", "PrimaryCompletionDate": "2020-10-31", "Interventions": [ { "Name": "18F-PSMA-1007 PET tracer", "Type": "OTHER", "Description": "18F-PSMA-1007 PET/CT", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Radboud University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02443194", "BriefTitle": "The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients", "OfficialTitle": "The Effect of Duloxetine on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2015-05", "PrimaryCompletionDate": "2015-11", "Interventions": [ { "Name": "duloxetine", "Type": "DRUG", "Description": "after randomization the patient will receive cymbalta/ placebo for 3 months", "OtherNames": [ "cymbalta" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PLACEBO", "Type": "DRUG", "Description": "after randomization the patient will receive cymbalta/ placebo for 3 months", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "michal roll", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "PREVENTION", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01812603", "BriefTitle": "A Safety Study of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-09", "PrimaryCompletionDate": "2015-01", "Interventions": [ { "Name": "Sativex", "Type": "DRUG", "Description": "Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).", "OtherNames": [ "THC/CBD spray", "Nabiximols", "GW-1000-02" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jazz Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05789394", "BriefTitle": "Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy", "OfficialTitle": "Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-06-16", "PrimaryCompletionDate": "2026-07-24", "Interventions": [ { "Name": "Allogeneic Adipose-derived Mesenchymal Stem Cells", "Type": "BIOLOGICAL", "Description": "Receive IT", "OtherNames": [ "Allogeneic Adipose-derived MSCs", "Allogeneic Adipose-derived Stem/Stromal Cells", "Allogeneic Mesenchymal Stem/Stromal Cells" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood and tissue sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Craniotomy", "Type": "PROCEDURE", "Description": "Undergo craniotomy", "OtherNames": [ "incision of the skull", "Open Craniotomy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "MRIs", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Ommaya Reservoir Tap", "Type": "PROCEDURE", "Description": "Undergo Ommaya reservoir placement for collection of CSF", "OtherNames": [ "Ommaya Reservoir Access" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02704858", "BriefTitle": "Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma", "OfficialTitle": "An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent or Progressive Grade III or Grade IV Gliomas With IDH1 Mutation", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-08-01", "PrimaryCompletionDate": "2026-03-30", "Interventions": [ { "Name": "Perillyl alcohol", "Type": "DRUG", "Description": "Intranasal administration", "OtherNames": [ "NEO100" ], "modality": [ "Other" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Neonc Technologies, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT02209948", "BriefTitle": "Temozolomide 12 Cycles Versus 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.", "OfficialTitle": "Clinical Trial Phase IIB Randomized, Multicenter, of Continuation or Non Continuation With 6 Cycles of Temozolomide After the First 6 Cycles of Standard First-line Treatment in Patients With Glioblastoma.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-08-22", "PrimaryCompletionDate": "2019-06", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Grupo Español de Investigación en Neurooncología", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00612638", "BriefTitle": "Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas", "OfficialTitle": "Phase I Trail of Temodar Plus O6-Benzylguanine (O6-BG) (NSC 637037) Plus Irinotecan (CPT-11) (NSC 616348) in the Treatment of Patients With Recurrent / Progressive Cerebral Anaplastic Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "Temodar, O6-BG, and Irinotecan", "Type": "DRUG", "Description": "2 separate strata accrued independently: Stratum 1-pts receiving Dilantin, Tegretol or phenobarbital. Stratum 2-pts on anti-convulsants other than Dilantin, Tegretol/phenobarbital/pts not on any anti-convulsants. O6-BG administered intravenously 120mg/m2, over 1hr, prior to administration of Temozolomide on day 1 of 21day cycle. O6-BG administered intravenously 30mg/m2/day, over 48hrs, immediately after completion of CPT-11 infusion on day 1 of 21-day cycle. Temozolomide administered orally 355mg/m2 within 60 mins of end of 1hr O6-BG infusion. Treatment cycles may be repeated every 3wks following dose of Temozolomide from previous cycle. CPT-11 administered intravenously in fasting state over 90mins. CPT-11 infusion will begin 1hr after Temozolomide administration. Initial doses 60mg/m2 for stratum 1 \\& 40mg/m2 for stratum2. Treatment cycles repeated every 3 wks following dose of CPT-11 from previous cycle.", "OtherNames": [ "Temodar-Temozolomide", "O6-Benzylguanine-O6-BG", "Irinotecan-Camptosar-CPT 11" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Keryx / AOI Pharmaceuticals, Inc.", "Pharmacia" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02974621", "BriefTitle": "Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "A Randomized Phase 2 Trial of Cediranib and Olaparib Compared to Bevacizumab in Patients With Recurrent Glioblastoma Who Have Not Received Prior VEGF Therapy", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2017-12-07", "PrimaryCompletionDate": "2022-12-31", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 215", "ABP-215", "ABP215", "Alymsys", "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF Monoclonal Antibody SIBP04", "Anti-VEGF rhuMAb", "Avastin", "Avzivi", "Aybintio", "BAT 1706", "BAT-1706", "BAT1706", "BAT1706 Biosimilar", "Bevacizumab awwb", "Bevacizumab Biosimilar ABP 215", "Bevacizumab Biosimilar BAT1706", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar CT-P16", "Bevacizumab Biosimilar FKB238", "Bevacizumab Biosimilar GB-222", "Bevacizumab Biosimilar HD204", "Bevacizumab Biosimilar HLX04", "Bevacizumab Biosimilar IBI305", "Bevacizumab Biosimilar LY01008", "Bevacizumab Biosimilar MB02", "Bevacizumab Biosimilar MIL60", "Bevacizumab Biosimilar Mvasi", "Bevacizumab Biosimilar MYL-1402O", "Bevacizumab Biosimilar QL 1101", "Bevacizumab Biosimilar QL1101", "Bevacizumab Biosimilar RPH-001", "Bevacizumab Biosimilar SCT501", "Bevacizumab Biosimilar Zirabev", "Bevacizumab-adcd", "Bevacizumab-awwb", "Bevacizumab-aybi", "Bevacizumab-bvzr", "Bevacizumab-equi", "Bevacizumab-maly", "Bevacizumab-onbe", "Bevacizumab-tnjn", "BP102", "BP102 Biosimilar", "CT P16", "CT-P16", "CTP16", "Equidacent", "FKB 238", "FKB-238", "FKB238", "HD204", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "MB 02", "MB-02", "MB02", "Mvasi", "MYL-1402O", "Onbevzi", "Oyavas", "PF 06439535", "PF-06439535", "PF06439535", "QL1101", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF", "SCT501", "SIBP 04", "SIBP-04", "SIBP04", "Vegzelma", "Zirabev" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "DNA repair inhibitor" ] } }, { "Name": "Cediranib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZ-D2171", "AZD 2171", "AZD2171" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "DNA repair inhibitor" ] } }, { "Name": "Cediranib Maleate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD2171", "AZD2171 Maleate", "Recentin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "DNA repair inhibitor" ] } }, { "Name": "Olaparib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD 2281", "AZD-2281", "AZD2281", "KU 0059436", "KU-0059436", "KU0059436", "Lynparza", "Olanib", "Olaparix", "PARP Inhibitor AZD2281" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PARP", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "DNA repair inhibitor" ] } }, { "NCTId": "NCT03657576", "BriefTitle": "Trial of C134 in Patients With Recurrent GBM", "OfficialTitle": "A Phase I Trial of IRS-1 HSV C134 Administered Intratumorally in Patients With Recurrent Malignant Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-09-23", "PrimaryCompletionDate": "2024-10-25", "Interventions": [ { "Name": "C134", "Type": "BIOLOGICAL", "Description": "C134 is a virus that was created from an oncolytic Herpes Simplex Virus (oHSV) known to infect and kill tumor cells. The Investigators have made changes to the original virus to make C134. It efficiently infects tumor cells (not normal healthy cells) and induces an immune response to fight the cancer as well.", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [ "Gateway for Cancer Research", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02910804", "BriefTitle": "IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma", "OfficialTitle": "PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2015-11", "PrimaryCompletionDate": "2018-12", "Interventions": [ { "Name": "68Ga-BBN-IRDye800CW", "Type": "DRUG", "Description": null, "OtherNames": [ "BBN-IRDye800CW" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET/NIRF", "Type": "DEVICE", "Description": null, "OtherNames": [ "Positron emission tomography/Near-infrared fluorescent" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET/NIR fluorescent imaging-guided surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Peking Union Medical College Hospital", "National Institute for Biomedical Imaging and Bioengineering (NIBIB)", "Chinese Academy of Sciences" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00586508", "BriefTitle": "Trial of Enzastaurin and Bevacizumab in Participants With Recurrent Malignant Gliomas", "OfficialTitle": "A Phase II Trial of Enzastaurin in Combination With Bevacizumab in Adults With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-11", "PrimaryCompletionDate": "2013-10", "Interventions": [ { "Name": "enzastaurin", "Type": "DRUG", "Description": "1125 milligrams (mg) loading dose then 500 or 875 mg, orally, daily, 4-week cycles with participants evaluated after each cycle. The dose difference is for participants who are on enzyme-inducing antiepileptic drugs (EIAED) versus non-enzyme inducing antiepileptic drugs (NEIAED).", "OtherNames": [ "LY317615" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "DRUG", "Description": "10 milligrams per kilogram (mg/kg), intravenously (IV), every 2 weeks, participants are evaluated after each cycle (4-week cycles).", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Enzyme-inducing antiepileptic drugs (EIAED)", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Non-enzyme inducing antiepileptic drugs (NEIAED)", "Type": "DRUG", "Description": "Administered orally", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Eli Lilly and Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05664243", "BriefTitle": "A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 1b / 2 Open-label Study to Investigate the Safety, Tolerance and Efficacy of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide (TMZ) in Subjects With Recurrent or Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-09-08", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "Autologous genetically modified gamma-delta T cells", "Type": "BIOLOGICAL", "Description": "Arm A: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Allogeneic genetically modified gamma-delta T cells", "Type": "BIOLOGICAL", "Description": "Phase 1b and Arm B: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with D1 of TMZ 150mg/m2\n\nArms C: Cells will be administered on Day 1 of each of 6, 28-day cycles in combination with TMZ maintenance", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "In8bio Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06641908", "BriefTitle": "Anti-GD2 ADC M3554 in Advanced Solid Tumors", "OfficialTitle": "A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-11-08", "PrimaryCompletionDate": "2026-10-27", "Interventions": [ { "Name": "M3554", "Type": "DRUG", "Description": "M3554 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose is determined in participants with STS (dose escalation A) and glioblastoma and IDH wildtype (dose escalation B).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "EMD Serono Research & Development Institute, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT03522298", "BriefTitle": "Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma", "OfficialTitle": "A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of the PI3K/mTOR Inhibitor Paxalisib (GDC-0084) Administered to Patients With Glioblastoma Characterized by Unmethylated O6-methylguanine-methyltransferase Promoter Status Following Surgical Resection and Standard Concomitant Chemoradiation Therapy With Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-05-15", "PrimaryCompletionDate": "2023-03-30", "Interventions": [ { "Name": "Paxalisib (GDC-0084)", "Type": "DRUG", "Description": "Patients will be dosed orally with paxalisib (GDC-0084) capsules (15-mg each) at the dose and schedule to which they are assigned.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PI3K", "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Kazia Therapeutics Limited", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PI3K", "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06039709", "BriefTitle": "Sonodynamic Therapy in Patients With Recurrent GBM", "OfficialTitle": "Pilot Study of Sonodynamic Therapy With 5-ALA for the Treatment of Recurrent Glioblastoma Using Neuronavigation-Guided Low-Intensity Focused Ultrasound", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-01-31", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "5-ALA and Low-Intensity Focused Ultrasound (SDT)", "Type": "COMBINATION_PRODUCT", "Description": "5-ALA (20mg/kg orally) given \\~6 hours prior to LIFU. Focused ultrasound will target a maximum of 50% of the tumor.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shayan Moosa, MD", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04606316", "BriefTitle": "Surgical Nivolumab And Ipilimumab For Recurrent GBM", "OfficialTitle": "A Phase Ib Clinical Trial to Evaluate Early Immunologic Pharmacodynamic Parameters Following Neoadjuvant Anti-PD-1 (Nivolumab), or the Combination of Anti-PD-1 Plus Anti-CTLA-4 (Nivolumab Plus Ipilimumab) in Patients With Surgically Accessible Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-02-01", "PrimaryCompletionDate": "2025-12-30", "Interventions": [ { "Name": "Nivolumab-Placebo", "Type": "DRUG", "Description": "Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "Given as intravenous (IV) infusion into a vein.", "OtherNames": [ "Opdivo" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Ipilimumab-Placebo", "Type": "DRUG", "Description": "Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Ipilimumab", "Type": "DRUG", "Description": "Given as intravenous (IV) infusion into a vein.", "OtherNames": [ "Yervoy" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.", "OtherNames": [ "Resection" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Patrick Wen, MD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00045708", "BriefTitle": "A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-10", "PrimaryCompletionDate": "2010-05", "Interventions": [ { "Name": "ixabepilone", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BMS-247550", "epothilone B lactam", "Ixempra" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Anticonvulsant", "Type": "DRUG", "Description": "Drugs that induce hepatic Metabolic enzymes", "OtherNames": [ "P450" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06069726", "BriefTitle": "A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial", "OfficialTitle": "A Multicenter Trial to Identify Optimal Atezolizumab Biomarkers in the Setting of Recurrent Glioblastoma. The MOAB Trial", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-03-21", "PrimaryCompletionDate": "2028-01-01", "Interventions": [ { "Name": "Atezolizumab", "Type": "DRUG", "Description": "One dose of atezolizumab will be given prior to resection.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT00503204", "BriefTitle": "Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour", "OfficialTitle": "A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-09", "PrimaryCompletionDate": "2008-12", "Interventions": [ { "Name": "Cediranib", "Type": "DRUG", "Description": "oral tablet", "OtherNames": [ "RECENTIN™", "AZD2171" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "oral capsule", "OtherNames": [ "CCNU", "CeeNU®" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AstraZeneca", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01204684", "BriefTitle": "Dendritic Cell Vaccine for Patients With Brain Tumors", "OfficialTitle": "A Phase II Clinical Trial Evaluating Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen +/- Toll-like Receptor Agonists for the Treatment of Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-10-08", "PrimaryCompletionDate": "2024-08-21", "Interventions": [ { "Name": "autologous tumor lysate-pulsed DC vaccination", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor lysate-pulsed DC vaccination+0.2% resiquimod", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Tumor-lysate pulsed DC vaccination +adjuvant polyICLC", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03965494", "BriefTitle": "AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery", "OfficialTitle": "Pilot Surgical PK Study of BGB324 in Recurrent Glioblastoma Patients", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-01-02", "PrimaryCompletionDate": "2023-10-31", "Interventions": [ { "Name": "BGB 324 (before surgery)", "Type": "DRUG", "Description": "Given by mouth either BEFORE therapeutic conventional surgery", "OtherNames": [ "AXL Inhibitor BGB324", "Bemcentinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "BGB 324 (after surgery)", "Type": "DRUG", "Description": "Given by mouth either AFTER therapeutic conventional surgery", "OtherNames": [ "AXL Inhibitor BGB324", "Bemcentinib" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "BerGenBio ASA" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00509301", "BriefTitle": "Safety & Radiation Distribution Study of Cotara® in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "Open-label Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-11", "PrimaryCompletionDate": "2010-03", "Interventions": [ { "Name": "131-I-chTNT-1/B MAB", "Type": "DRUG", "Description": "The study drug is given interstitially for approximately 25 hours at a dose of 1.5, 2.0, or 2.5 mCi/cc.", "OtherNames": [ "Cotara" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Peregrine Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02853565", "BriefTitle": "A Study of CAN008 for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I Study of CAN008 Plus Concomitant Temozolomide During and After Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-08", "PrimaryCompletionDate": "2018-09", "Interventions": [ { "Name": "CAN008", "Type": "DRUG", "Description": "The dose escalation in the phase I study including 200mg in the first cohort and 400mg in the second cohort to Recommended for Phase 2 Dose (RP2D)", "OtherNames": [ "APG101" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CANbridge Life Sciences Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01464177", "BriefTitle": "Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme", "OfficialTitle": "Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-10", "PrimaryCompletionDate": "2021-07", "Interventions": [ { "Name": "Stereotactic hypofractionated RT 5x5Gy", "Type": "RADIATION", "Description": "Stereotactic hypofractionated radiation therapy delivered as follows:\n\n* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.\n* Planning tumor volume (PTV) equals GTV plus 3mm margin.\n* The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.\n* RT to begin in a maximum of 2 weeks after randomization", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Stereotactic hypofractionated RT 5x7Gy", "Type": "RADIATION", "Description": "Stereotactic hypofractionated radiation therapy delivered as follows:\n\n* Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.\n* Planning tumor volume (PTV) equals GTV plus 3mm margin.\n* The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.\n* RT to begin in a maximum of 2 weeks after randomization.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Andre Tsin Chih Chen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00107237", "BriefTitle": "AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme", "OfficialTitle": "A Phase IB/II Multicenter, Two-Arm, Dose-Escalation Study of Oral AEE788 Administered in Combination With Oral RAD001 on a Continuous Once Daily Dosing Schedule in Adult Patients With First or Second Recurrent or Relapsing Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2003-10", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "AEE788", "Type": "DRUG", "Description": "AEE788 was available in the form of a hard gelatin capsule of 50 mg or 100 mg strengths and packaged in bottles.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "everolimus", "Type": "DRUG", "Description": "Everolimus was formulated as tablets of 2.5 mg and 5 mg strength and supplied in blister packs.", "OtherNames": [ "RAD001" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT00687765", "BriefTitle": "Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma", "OfficialTitle": "Phase I/II Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2008-07", "PrimaryCompletionDate": "2015-06", "Interventions": [ { "Name": "bsi-201 plus temozolomide", "Type": "DRUG", "Description": "BSI-201 given iv. 2x weekly, temozolomide given orally", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sanofi", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05929456", "BriefTitle": "Multispectral Bimodal Fluorescence Guided Surgery of High-grade Glioma With Cetuximab-800CW and 5-ALA (5-aminolevulinic Acid)", "OfficialTitle": "Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2023-05-05", "PrimaryCompletionDate": "2024-10-01", "Interventions": [ { "Name": "Cetuximab-IRDye800", "Type": "DRUG", "Description": "patients will receive a single IV injection of Cetuximab-IRDye800CW 2-4 days prior to surgert. The IMP (Investigational medicinal product)/tracer will be used for fluorescence guided surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University Medical Center Groningen", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00509431", "BriefTitle": "Erlotinib and Sirolimus in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase I/II, Dual-Center, Open-Label Trial of the Safety and Efficacy of Tarceva™ (Erlotinib Hydrochloride) Plus Sirolimus in Patients With Recurrent Malignant Glioma Not on P450-Inducing Anti-Epileptics", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-08", "PrimaryCompletionDate": "2011-12", "Interventions": [ { "Name": "Erlotinib + Sirolimus", "Type": "DRUG", "Description": "In arm I of dose escalation phase,starting dose of erlotinib is 150 mg daily. Starting dose of sirolimus includes a 15 mg loading dose, followed by continuous dosing at 5 mg daily.Dose escalation will proceed according to protocol Phase II of the study was not conducted only Phase I", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03879512", "BriefTitle": "Autologous Dendritic Cells, Metronomic Cyclophosphamide and Checkpoint Blockade in Children With Relapsed HGG", "OfficialTitle": "Autologous Dendritic Cells and Metronomic Cyclophosphamide in Combination With Checkpoint Blockade for Relapsed High-Grade Gliomas in Children and Adolescents", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-02-07", "PrimaryCompletionDate": "2024-07-31", "Interventions": [ { "Name": "depletion of regulatory T cells", "Type": "DRUG", "Description": "oral metronomic cyclophosphamide", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "reoperation", "Type": "PROCEDURE", "Description": "resection of relapsed tumor in order to improve clinical condition of the patient and to acquire tumor tissue for vaccine generation", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "cancer vaccine", "Type": "BIOLOGICAL", "Description": "4 weekly intradermal injections of lysate-loaded dendritic cells, followed by 3 monthly boost vaccines with tumor lysate and further boost vaccines every three months", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "checkpoint blockade", "Type": "BIOLOGICAL", "Description": "Immediately one week after the DC-induction vaccines, patients will receive four applications of Nivolumab/Ipilimumab double checkpoint blockade in threeweekly intervals, followed by Nivolumab monotherapy every month for a total duration of one year.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Wuerzburg University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4", "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT01290692", "BriefTitle": "Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma", "OfficialTitle": "Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-06", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "TVI-Brain-1", "Type": "BIOLOGICAL", "Description": "Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.", "OtherNames": [ "Cancer vaccine plus immune adjuvant plus activated WBC" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "TVAX Biomedical", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05768087", "BriefTitle": "Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients", "OfficialTitle": "Escalated Dose Proton Therapy Within the Multimodality Treatment of Glioblastoma Patients - A Phase 1 Proton Dose Finding Trial -", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-04-15", "PrimaryCompletionDate": "2026-10", "Interventions": [ { "Name": "Escalated proton therapy", "Type": "RADIATION", "Description": "According to allocated dose level: level 1-8, 69-90 Gy in 30 fractions of 2.3-3.0 Gy, to a subvolume of the radiation target", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Aarhus", "LeadSponsorClass": "OTHER", "Collaborators": [ "Danish Cancer Society" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05131763", "BriefTitle": "NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors", "OfficialTitle": "A Phase I Clinical Trial of NKG2D-based CAR T-cells Injection for Subjects With Relapsed/Refractory NKG2DL+ Solid Tumors", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2021-03-01", "PrimaryCompletionDate": "2022-12-01", "Interventions": [ { "Name": "NKG2D-based CAR T-cells", "Type": "BIOLOGICAL", "Description": "Autologous genetically modified anti-NKG2DLs CAR transduced T cells", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Fudan University", "LeadSponsorClass": "OTHER", "Collaborators": [ "KAEDI" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004147", "BriefTitle": "COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors", "OfficialTitle": "A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "incyclinide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00014521", "BriefTitle": "Karenitecin in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-01", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "karenitecin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04596930", "BriefTitle": "MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma", "OfficialTitle": "MR-guided LITT Therapy in Patients With Primary Irresectable Glioblastoma: a Randomized Pilot Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2021-01-22", "PrimaryCompletionDate": "2022-02-11", "Interventions": [ { "Name": "Laser ablation thermal therapy", "Type": "PROCEDURE", "Description": "The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Radboud University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00639639", "BriefTitle": "Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Anti-Tumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme During Recovery From Therapeutic Temozolomide-induced Lymphopenia", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-02-06", "PrimaryCompletionDate": "2017-04-15", "Interventions": [ { "Name": "tetanus toxoid", "Type": "BIOLOGICAL", "Description": "Given by injection", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "therapeutic autologous dendritic cells", "Type": "BIOLOGICAL", "Description": "Given intradermally", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "therapeutic autologous lymphocytes", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Gary Archer Ph.D.", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00780819", "BriefTitle": "Borderzone Sampling", "OfficialTitle": "Does Borderzone Contrast Enhancement on Intraoperative MRI During High Grade Glioma Resection Correlate With Residual Tumor?", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2008-10", "PrimaryCompletionDate": "2009-07", "Interventions": [ { "Name": "PoleStar N20 intraoperative MRI", "Type": "DEVICE", "Description": "low field strength mobile intraoperative MRI system (0,15 Tesla) with local Faraday shielding (using the StarShield system)", "OtherNames": [ "manufactured by Odin Medical Technologies (Yokneam, Israel), incorporated in Medtronic Navigation (Louisville, CO; USA)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Maastricht University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03234712", "BriefTitle": "A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)", "OfficialTitle": "A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-10-10", "PrimaryCompletionDate": "2021-04-14", "Interventions": [ { "Name": "ABBV-321", "Type": "DRUG", "Description": "Intravenous infusion", "OtherNames": [ "Serclutamab Talirine" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "AbbVie", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT05904119", "BriefTitle": "Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study", "OfficialTitle": "Lomustine With and Without Reirradiation for First Progression of Glioblastoma: a Randomized Phase III Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-03-15", "PrimaryCompletionDate": "2027-09", "Interventions": [ { "Name": "Lomustine", "Type": "DRUG", "Description": "Oral administration of Lomustine", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Reirradiation", "Type": "RADIATION", "Description": "Given at least 6 months after the end of prior radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "European Organisation for Research and Treatment of Cancer - EORTC", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Swiss Cancer Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03603405", "BriefTitle": "HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM", "OfficialTitle": "Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination with Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-02-28", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "ADV/HSV-tk (gene therapy)", "Type": "DRUG", "Description": "The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy", "OtherNames": [ "gene therapy, gene therapy", "HSV-tk" ], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "The Methodist Hospital Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04763031", "BriefTitle": "Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT", "OfficialTitle": "A Pilot Study of Patients With Recurrent Glioblastoma Treated With Maximal Safe Neurosurgical Resection, Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® Electronic Brachytherapy System", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2021-03-05", "PrimaryCompletionDate": "2023-11-03", "Interventions": [ { "Name": "Intra-operative Radiation Therapy - IORT", "Type": "RADIATION", "Description": "Single dose of 20 Gy", "OtherNames": [ "Electronic Brachytherapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Parkridge Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04391595", "BriefTitle": "LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients", "OfficialTitle": "A Phase 0/2 Study of LY3214996 (ERK Inhibitor) in Combination With Abemaciclib (CDK4 and 6 Inhibitor) in Recurrent Glioblastoma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-07-11", "PrimaryCompletionDate": "2023-07-27", "Interventions": [ { "Name": "Abemaciclib", "Type": "DRUG", "Description": "100 mg of Abemaciclib BID for 11 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "LY3214996", "Type": "DRUG", "Description": "400 mg of LY3214996 daily for 6 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Institute", "Ivy Brain Tumor Center", "Eli Lilly and Company" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT04881032", "BriefTitle": "AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Study of AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-03-07", "PrimaryCompletionDate": "2025-09", "Interventions": [ { "Name": "Polysiloxane Gd-Chelates based nanoparticles (AGuIX)", "Type": "DRUG", "Description": "Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiotherapy", "Type": "RADIATION", "Description": "60 Gy in 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.\n\nAfter a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days .", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Jean Perrin", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ministry for Health and Solidarity, France" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02060955", "BriefTitle": "Randomized Phase 2 Study to Investigate Efficacy of ALECSAT in Patients With GBM Measured Compared to Avastin/Irinotecan", "OfficialTitle": "An Open-labelled, Randomized Phase II Study to Investigate Efficacy of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells (ALECSAT) in Patients With GBM Measured as Progression Free Survival Compared to Avastin/Irinotecan", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2015-06", "Interventions": [ { "Name": "ALECSAT", "Type": "BIOLOGICAL", "Description": "The ALECSAT will be administered at week 4, 9, 14, 26 and week 46. Cells are re-suspended in a plasmalyte injection fluid up to a total volume of 20 ml. The 20 ml cell suspension will contain between 10 million and 1 billion cells. Each dose is supplied in a sterile 20 ml syringe and should be injected intravenously.", "OtherNames": [ "ALECSAT, the investigational product," ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab/Irinotecan", "Type": "DRUG", "Description": "Patients allocated to the Bevacizumab/Irinotecan (control group) will receive treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle consist of 2 dosing days; day 1 and day 15 in the cycle.", "OtherNames": [ "Bevacizumab", "Irinotecan" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "CytoVac A/S", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01227434", "BriefTitle": "A Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma", "OfficialTitle": "A Phase II Study of PD 0332991 in Patients With Recurrent Rb Positive Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2010-09", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "PD 0332991 (pre-surgery)", "Type": "DRUG", "Description": "PD 0332991 for 7 days prior to an indicated, intended surgical resection for progression", "OtherNames": [ "Pfizer PD 0332991", "palbociclib", "IBRANCE, Pfizer, Inc." ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "PD 0332991", "Type": "DRUG", "Description": "PD 0332991 daily for 21 consecutive days followed by a 7 day break off therapy, repeating cycles", "OtherNames": [ "Pfizer PD 0332991", "palbociclib", "IBRANCE, Pfizer, Inc." ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Resection as clinical care", "Type": "PROCEDURE", "Description": "Indicated, intended, surgical resection as clinical care", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of California, San Francisco", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "CDK" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT00006263", "BriefTitle": "Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma", "OfficialTitle": "Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "1997-11", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00138216", "BriefTitle": "Temozolomide, Vincristine, and Irinotecan in Treating Young Patients With Refractory Solid Tumors", "OfficialTitle": "A Phase I Study of Temozolomide, Oral Irinotecan, and Vincristine for Children With Refractory Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-10", "PrimaryCompletionDate": "2009-06", "Interventions": [ { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07349693", "BriefTitle": "Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma", "OfficialTitle": "A Randomized Trial to Assess the Efficacy and Safety of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2026-11-01", "PrimaryCompletionDate": "2028-12-01", "Interventions": [ { "Name": "Cerebraca wafer", "Type": "DRUG", "Description": "Cerebraca Wafer, (75 mg (Z)-n-butylidenephthalide, (Z)-BP, Implant)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide (for relapsed malignant glioma)", "Type": "DRUG", "Description": "TMZ as the standard-of-care (SOC) treatment for recurrent glioblastoma.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Everfront Biotech Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00006452", "BriefTitle": "Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A Phase I Trial to Evaluate Repetitive Intravenous Doses of Gadolinium-Texaphyrin as a Radiosensitizer in Patients With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-04-10", "PrimaryCompletionDate": "2003-05-09", "Interventions": [ { "Name": "motexafin gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00010049", "BriefTitle": "Imatinib Mesylate in Treating Patients With Recurrent Malignant Glioma or Meningioma", "OfficialTitle": "Phase I/II Trial of STI571 (NSC 716051) in Patients With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-02-27", "PrimaryCompletionDate": "2005-03-17", "Interventions": [ { "Name": "imatinib mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00107458", "BriefTitle": "Valproic Acid in Treating Young Patients With Recurrent or Refractory Solid Tumors or CNS Tumors", "OfficialTitle": "A Phase I Study of Valproic Acid in Children With Recurrent/Progressive Solid Tumors Including CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-05", "PrimaryCompletionDate": "2007-10", "Interventions": [ { "Name": "valproic acid", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Children's Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07089758", "BriefTitle": "A Study for Cerebral Open Flow Microperfusion", "OfficialTitle": "A Pilot Feasibility Study for Cerebral Open Flow Microperfusion in Patients Undergoing Planned Neurosurgical Resection of Diseased Parenchyma.", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2026-02-01", "PrimaryCompletionDate": "2028-02", "Interventions": [ { "Name": "Cerebral open flow microperfusion", "Type": "DEVICE", "Description": "Patients will undergo intra-operative microperfusion using Joanneum Research's cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump. This process utilizes a probe (catheter) inserted into the parenchyma to collect analytes of any size and polarity from the microenvironment. The microperfusion pump peristaltically pushes and pulls perfusate with no net fluid-exchange when the pump heads are set at equal flow rates. As perfusate enters the tip of the microperfusion catheter, analytes are exchanged based on a gradient between the interstitial fluid and the perfusate. The sample is then recovered via the \"pull\" portion of the peristaltatic microperfusion pump, enabling constant sampling volumes and preventing loss of the perfusate into the tissue.\n\nThe duration is 60-80 minutes (dependent on the speed of progress resecting portions of the tumor without catheters)", "OtherNames": [ "Joanneum Research cerebral open flow microperfusion" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03856099", "BriefTitle": "TTAC-0001 Phase II Trial With Recurrent Glioblastoma Progressed on Bevacizumab", "OfficialTitle": "A Multicenter, Open-Label, Phase Ⅱ Clinical Trial to Evaluate the Safety and Efficacy of TTAC-0001, a Fully Human Monoclonal Antibody in Patients With Recurrent Glioblastoma Progressed on Bevacizumab Including Therapy", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2019-11-13", "PrimaryCompletionDate": "2022-07-15", "Interventions": [ { "Name": "TTAC-0001", "Type": "DRUG", "Description": "* Investigational product (IP): TTAC-0001\n* Treatment groups: 3 dose groups\n\n * Dose group A : TTAC-0001 16 mg/kg on D1 and D15\n * Dose group B : TTAC-0001 20 mg/kg on D1 and D15\n * Dose group C : TTAC-0001 24 mg/kg on D1 and D15\n* Cycle: 4 weeks (28 days per cycle)", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "PharmAbcine", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03395587", "BriefTitle": "Efficiency of Vaccination with Lysate-loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase II Trial of Vaccination with Lysate-loaded, Mature Dendritic Cells Integrated Into Standard Radiochemotherapy in Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-03-06", "PrimaryCompletionDate": "2027-05", "Interventions": [ { "Name": "Autologous, tumor lysate-loaded, mature dendritic cells (DC)", "Type": "BIOLOGICAL", "Description": "Advanced therapy medicinal product (ATMP) produced at the University Hospital Düsseldorf according to Good Manufacturing Practice (GMP) with production permission according §13 AMG (German Drug Law) of the local authorities (Bezirks¬regierung Düsseldorf)", "OtherNames": [ "dendritic cell vaccination" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "standard therapy", "Type": "DRUG", "Description": "temozolomide, fractionated radiochemotherapy", "OtherNames": [ "temozolomide, fractionated radiochemotherapy" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Heinrich-Heine University, Duesseldorf", "LeadSponsorClass": "OTHER", "Collaborators": [ "German Federal Ministry of Education and Research" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02626364", "BriefTitle": "Study of Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification", "OfficialTitle": "Phase II Study of Single-agent Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-04", "PrimaryCompletionDate": "2020-07", "Interventions": [ { "Name": "crenolanib", "Type": "DRUG", "Description": "single-agent crenolanib at 100 mg PO TID", "OtherNames": [ "CP-868,596-26" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Arog Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03696355", "BriefTitle": "Study of GDC-0084 in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas", "OfficialTitle": "Phase I Study of GDC-0084, a Brain-Penetrant PI3 Kinase/mTOR Inhibitor, in Pediatric Patients With Newly Diagnosed Diffuse Intrinsic Pontine Glioma or Diffuse Midline Gliomas After Radiation Therapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-11-19", "PrimaryCompletionDate": "2021-04-02", "Interventions": [ { "Name": "GDC-0084", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Both photon and proton therapy modalities will be allowed.", "OtherNames": [ "irradiation", "radiotherapy", "radiation", "external beam radiation therapy (EBRT)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Kazia Therapeutics Limited" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT01392352", "BriefTitle": "HYPAZ: Hypertension Induced by Pazopanib", "OfficialTitle": "HYPAZ: An Open-label Investigation Into Hypertension Induced by Pazopanib Therapy", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-04", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Pazopanib", "Type": "DRUG", "Description": "2 x 400mg pazopanib tablets taken once daily for 12 weeks", "OtherNames": [ "Votrient" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cambridge University Hospitals NHS Foundation Trust", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Cambridge" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04373785", "BriefTitle": "NG101m Adjuvant Therapy in Glioblastoma Patients", "OfficialTitle": "A Multi-Center Pilot/Phase I and Phase II Clinical Trial of NG101m Adjuvant Therapy in Newly Diagnosed Glioblastoma Patients", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2027-01-01", "PrimaryCompletionDate": "2030-07-30", "Interventions": [ { "Name": "Intensity-modulated radiation therapy", "Type": "RADIATION", "Description": "Intensity-modulated radiation therapy (IMRT) in daily fractions of 2.67 Gy given 5 days per week for 3 weeks, for a total of 40.05 Gy.", "OtherNames": [ "radiation therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Oral temozolomide (75 mg/m2), given 5 days per week, for 3 weeks during radiotherapy.\n\n1 month after the discontinuation of radiotherapy, oral temozolomide is restarted at 150 to 200 mg/m2 for 5 days during each 28-day cycle for 12 cycles.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "NG101m", "Type": "DRUG", "Description": "Oral NG101m capsule continuously twice daily.", "OtherNames": [ "NG101m regimen" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NeuGATE Theranostics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05015543", "BriefTitle": "Physical Training in Glioblastoma Patients During Cytotoxic Therapy", "OfficialTitle": "Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2020-07-23", "PrimaryCompletionDate": "2024-10-17", "Interventions": [ { "Name": "Personal Training Program", "Type": "OTHER", "Description": "One training sessions includes an interval training on a bicycle ergometer. The second one is a strength training with exercise machines. Both trainings are supplemented by coordinative aspects.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "University Hospital Muenster", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05388435", "BriefTitle": "Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients", "OfficialTitle": "A Phase 1/2, Open-Label, Multicenter, Dose-Finding Study of SKL27969 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy in Patients With Advanced Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-09-12", "PrimaryCompletionDate": "2024-03-01", "Interventions": [ { "Name": "SKL27969", "Type": "DRUG", "Description": "SKL27969 will be orally administered once daily on an intermittent dosing schedule (3 days on and 4 days off).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "SK Life Science, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00597493", "BriefTitle": "Ph. 2 Sorafenib + Protracted Temozolomide in Recurrent GBM", "OfficialTitle": "Phase 2 Study of Sorafenib Plus Protracted Temozolomide in Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-09", "PrimaryCompletionDate": "2009-02", "Interventions": [ { "Name": "Sorafenib and Temozolomide", "Type": "DRUG", "Description": "Temozolomide (50 mg per meter-squared of body surface area)every day by mouth in combination with sorafenib. Sorafenib will be taken by mouth twice every day. The dose of sorafenib will be 400 mg (2 x 200mg tablets).", "OtherNames": [ "Temodar", "Nexavar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bayer", "Schering-Plough" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06690216", "BriefTitle": "Evaluation of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors", "OfficialTitle": "Evaluation of the Value of [18F]AlF-NOTA-PCP2 PET/CT for PD-L1 Detection in Malignant Tumors", "OverallStatus": "ENROLLING_BY_INVITATION", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-03-30", "PrimaryCompletionDate": "2025-10-31", "Interventions": [ { "Name": "PET/CT （[18F]AlF-NOTA-PCP2）", "Type": "DIAGNOSTIC_TEST", "Description": "This intervention involves the use of \\[18F\\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \\[18F\\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "PD-L1" ], "classes": [] } }, { "Name": "[18F]AlF-NOTA-PCP2 PET/CT Imaging for PD-L1 Expression in Malignant Tumors", "Type": "DIAGNOSTIC_TEST", "Description": "This intervention involves the use of \\[18F\\]AlF-NOTA-PCP2, a radiopharmaceutical agent specifically designed for PET/CT imaging. Patients will receive an intravenous injection of \\[18F\\]AlF-NOTA-PCP2, followed by whole-body PET/CT scanning one hour later. The primary purpose of this intervention is to assess PD-L1 expression in malignant tumors, including glioblastoma, head and neck squamous cell carcinoma, non-small cell lung cancer, and esophageal cancer, before the initiation of treatment. This imaging technique offers a non-invasive, repeatable, and comprehensive method to monitor PD-L1 status, in contrast to traditional tissue biopsy, which is invasive and limited to a single time point.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Man Hu", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET", "PD-L1" ], "classes": [] } }, { "NCTId": "NCT02119338", "BriefTitle": "5-ALA in Recurrent Glioma", "OfficialTitle": "Barrow ALA Trial for Recurrent Gliomas", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2014-02", "PrimaryCompletionDate": "2017-06", "Interventions": [ { "Name": "5-ala", "Type": "DRUG", "Description": "dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.", "OtherNames": [ "5-aminolevulinic acid", "Levulin(R)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01507506", "BriefTitle": "Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma", "OfficialTitle": "Phase III Randomized Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma : Standard 3D Conformational Radiotherapy Versus Intensity-modulated Radiotherapy With Simultaneous-integrated Boost Guided by Magnetic Resonance Spectroscopic Imaging", "OverallStatus": "TERMINATED", "Phase": [ "PHASE3" ], "StartDate": "2011-03-15", "PrimaryCompletionDate": "2020-01-02", "Interventions": [ { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Conventional arm: 3D conformational radiotherapy (arm A): 60 Gy per fractions of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with a linear accelerator equipped with a portal imaging.\n\n\\+\n\nChemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :\n\n* during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day,\n* post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Experimental arm", "Type": "RADIATION", "Description": "Conformational radiotherapy with simultaneous integrated boost by intensity modulation (Arm B): 60 Gy per fraction of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with concomitant daily superimposed boost on spectroscopic active region (PTV2) corresponding to the ratio Cho / NAA\\> 2 + 0.7 mm + contrast enhancement + 3mm. The PTV2 will receive a daily dose of 2.4 Gy for a cumulative dose of 72 Gy Only irradiation with simultaneous integrated boost are allowed\n\n\\+\n\nChemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :\n\n* during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day,\n* post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05341947", "BriefTitle": "Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2026-06", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "Activated T cells", "Type": "BIOLOGICAL", "Description": "Activated T cells (ATC) administered intravenously at one timepoint", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jeremy Rudnick, M.D", "LeadSponsorClass": "OTHER", "Collaborators": [ "Kairos Pharma" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04610229", "BriefTitle": "Safety of IMRT Treatment With Inhomogeneous Dose in Patients With Relapsed High-grade Gliomas.", "OfficialTitle": "Safety of Intensity-modulated Radiotherapy Treatment With Inhomogeneous Dose Distribution in Patients With Relapsed High-grade Gliomas.", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2016-02-01", "PrimaryCompletionDate": "2019-08-12", "Interventions": [ { "Name": "Hypofractionation guioded by dose painting", "Type": "RADIATION", "Description": "1", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Azienda USL Reggio Emilia - IRCCS", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01621542", "BriefTitle": "Clinical Study of WT2725 in Patients With Advanced Malignancies", "OfficialTitle": "Initial Phase 1 Study of WT2725 in Patients With Advanced Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-07-31", "PrimaryCompletionDate": "2017-05-17", "Interventions": [ { "Name": "WT2725", "Type": "BIOLOGICAL", "Description": "WT2725 injection Study drug will be administered every 1-4 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sumitomo Pharma America, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Sumitomo Pharma Co., Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04417088", "BriefTitle": "Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy", "OfficialTitle": "Assessment of Safety and Feasibility of Exablate Type 2 for Blood-Brain Barrier Disruption (BBBD) With Microbubble Resonators for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-11-06", "PrimaryCompletionDate": "2023-11-30", "Interventions": [ { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Exablate BBBD", "Type": "DEVICE", "Description": "BBB opening via Exablate Neuro Type 2 system with microbubble resonators.", "OtherNames": [ "Exablate Neuro" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00052780", "BriefTitle": "Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors", "OfficialTitle": "Phase I Trial of Temozolomide and O6-Benzylguanine in Pediatric Patients With Recurrent Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-10", "PrimaryCompletionDate": "2007-11", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "BG" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": "Given SC or IV", "OtherNames": [ "G-CSF", "Neupogen" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02654041", "BriefTitle": "Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients", "OfficialTitle": "Phase II, Open-label, Prospective, Single-arm, Single-center Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM Patients", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2016-03", "PrimaryCompletionDate": "2017-06", "Interventions": [ { "Name": "Combined T3 and Methimazole treatment", "Type": "DRUG", "Description": "Oral administration of T3 and Methimazole", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Musli Thyropeutics Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Tel-Aviv Sourasky Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00085254", "BriefTitle": "Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Safety Run-in/Randomized Phase II Trial of EMD 121974 in Conjunction With Concomitant and Adjuvant Temozolomide With Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-04", "PrimaryCompletionDate": "2012-11", "Interventions": [ { "Name": "cilengitide", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "EMD 121974" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo radiotherapy", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02655601", "BriefTitle": "Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001", "OfficialTitle": "A Phase 2 Trial for Patients With Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide, and BMX-001", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-09-25", "PrimaryCompletionDate": "2023-08-17", "Interventions": [ { "Name": "BMX-001", "Type": "DRUG", "Description": "BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates.", "OtherNames": [ "manganese butoxyethyl pyridyl porphyrin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "BioMimetix JV, LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Duke Cancer Institute", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05986851", "BriefTitle": "Azeliragon in MGMT Unmethylated Glioblastoma", "OfficialTitle": "A Phase II Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon in Patients With MGMT Unmethylated Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-09-12", "PrimaryCompletionDate": "2024-09-30", "Interventions": [ { "Name": "Azeliragon", "Type": "DRUG", "Description": "Oral capsule", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Cantex Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Medpace, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT02629757", "BriefTitle": "A Study on β-elemene as Maintain Treatment for Newly Diagnosed Malignant Gliomas", "OfficialTitle": "A Study on β-elemene as Maintain Treatment for Complete Remission Patients of Newly Diagnosed Malignant Gliomas Following Standard Treatment", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2015-04", "PrimaryCompletionDate": "2020-04", "Interventions": [ { "Name": "β-elemene", "Type": "DRUG", "Description": "β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sun Yat-sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03650257", "BriefTitle": "A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96", "OfficialTitle": "A Large-scale Research for Immunotherapy of Glioblastoma With Autologous Heat Shock Protein gp96", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2019-08-21", "PrimaryCompletionDate": "2021-08-20", "Interventions": [ { "Name": "gp96", "Type": "BIOLOGICAL", "Description": "25 mcg IH", "OtherNames": [ "Heat Shock", "HSPPC-96" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).", "OtherNames": [ "TZM" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiotherapy", "Type": "RADIATION", "Description": "Stupp regimen of radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cure&Sure Biotech Co., LTD", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Beijing Tiantan Hospital", "Shenzhen Second People's Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02455557", "BriefTitle": "SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2015-05-04", "PrimaryCompletionDate": "2019-10-23", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Montanide ISA 51 VG", "Type": "DRUG", "Description": "Given SC", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Sargramostim", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [ "23-L-Leucinecolony-Stimulating Factor 2", "DRG-0012", "Leukine", "Prokine", "rhu GM-CFS", "Sagramostim", "Sargramostatin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "SVN53-67/M57-KLH Peptide Vaccine", "Type": "BIOLOGICAL", "Description": "Given SC", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO or IV", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Roswell Park Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03526822", "BriefTitle": "Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.", "OfficialTitle": "Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2018-07-02", "PrimaryCompletionDate": "2027-07-01", "Interventions": [ { "Name": "Blood sample", "Type": "BIOLOGICAL", "Description": "Five blood sample in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Tumor sample", "Type": "BIOLOGICAL", "Description": "One tumor sample in operative period", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Assistance Publique Hopitaux De Marseille", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00902577", "BriefTitle": "MRI and PET/FMISO In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Multicenter, Phase II Assessment of Tumor Hypoxia in Glioblastoma Using 18F-Fluoromisonidazole (FMISO) With PET and MRI", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-08-24", "PrimaryCompletionDate": "2018-01-31", "Interventions": [ { "Name": "FMISO", "Type": "DRUG", "Description": "FMISO PET scans", "OtherNames": [ "18F-fluoromisonidazole", "18F-MISO", "18F-Misonidazole" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MRI", "Type": "OTHER", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance Imaging (MRI)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance", "MRI Scan", "NMR Imaging", "Nuclear Magnetic Resonance Imaging (NMRI)", "Nuclear Magnetic Resonance Imaging", "Medical Imaging, Nuclear Magnetic Resonance", "Magnetic Resonance (MR)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PET", "Type": "OTHER", "Description": "Undergo FMISO PET scan", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET Scan", "Positron Emission Tomography", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MRS", "Type": "OTHER", "Description": null, "OtherNames": [ "Magnetic Resonance Spectroscopy (MRS)", "Magnetic Resonance Imaging Spectroscopy (MRIS)", "Magnetic Resonance Spectroscopy Imaging (MRSI)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05293990", "BriefTitle": "Usefulness of Gadovist-enhanced FLAIR Imaging", "OfficialTitle": "Usefulness of Gadovist-enhanced FLAIR Imaging in Differentiation Between a Glioblastoma and Solitary Brain Metastasis: Single Center Prospective Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2017-02-02", "PrimaryCompletionDate": "2021-01-25", "Interventions": [ { "Name": "Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis", "Type": "RADIATION", "Description": "Usefulness of Gadovist-enhanced FLAIR imaging in differentiation between a glioblastoma and solitary brain metastasis", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Ryoo, In Seon", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02852655", "BriefTitle": "A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma", "OfficialTitle": "A Pilot Surgical Trial To Evaluate Early Immunologic Pharmacodynamic Parameters For The PD-1 Checkpoint Inhibitor, Pembrolizumab (MK-3475), In Patients With Surgically Accessible Recurrent/Progressive Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2016-09-21", "PrimaryCompletionDate": "2022-06-02", "Interventions": [ { "Name": "MK-3475", "Type": "DRUG", "Description": null, "OtherNames": [ "Pembrolizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT02866747", "BriefTitle": "A Study Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and Durvalumab for Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase I/II Multicenter Trial Evaluating the Association of Hypofractionated Stereotactic Radiation Therapy and the Anti-Programmed Death-ligand 1 (PD-L1) Durvalumab (Medi4736) for Patients With Recurrent Glioblastoma (STERIMGLI)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-01-17", "PrimaryCompletionDate": "2024-11-02", "Interventions": [ { "Name": "Hypofractionated stereotactic radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "Name": "Durvalumab", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Institut Claudius Regaud", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT01743950", "BriefTitle": "A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab", "OfficialTitle": "A Phase II Study of Pulse Reduced Dose Rate Radiation Therapy With Bevacizumab", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2012-12-03", "PrimaryCompletionDate": "2024-12-24", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "10mg/kg every 2weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "PRDR", "Type": "RADIATION", "Description": "Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.", "OtherNames": [ "re-irradiation" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Wisconsin, Madison", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00538850", "BriefTitle": "Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain", "OfficialTitle": "A Randomized, Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2007-10", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "Fentanyl sublingual spray", "Type": "DRUG", "Description": "In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached. In the double-blind period of the study, participants received fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, or 1600 µg determined in the open-label titration period of the study.", "OtherNames": [ "SUBSYS" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Matching placebo to fentanyl sublingual spray.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05076513", "BriefTitle": "Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma", "OfficialTitle": "A Phase 0 'Trigger' Trial of Niraparib in Newly-diagnosed Glioblastoma and Recurrent IDH1/2(+) ATRX Mutant Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-10-29", "PrimaryCompletionDate": "2024-03-19", "Interventions": [ { "Name": "Niraparib", "Type": "DRUG", "Description": "In Phase 0, 300mg administered orally QD for 4 days prior to resection.\n\nIn the Expansion cohort/Maintenance phase, niraparib will be administered as described below:\n\n* For patients weighing \\<77 kg (\\<170 lbs) OR with a platelet count \\<150,000/mcL, the recommended dosage is 200 mg taken orally once daily.\n* For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily.", "OtherNames": [ "Zejula" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "IDH", "PARP" ], "classes": [ "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [ "Barrow Neurological Institute", "Ivy Brain Tumor Center", "University of California, San Francisco", "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "IDH", "PARP" ], "classes": [ "DNA repair inhibitor" ] } }, { "NCTId": "NCT03185780", "BriefTitle": "Complementary/Integrative Medicine for Brain Cancer Patients", "OfficialTitle": "Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study", "OverallStatus": "WITHDRAWN", "Phase": [ "NA" ], "StartDate": "2018-07-01", "PrimaryCompletionDate": "2019-12-31", "Interventions": [ { "Name": "Acupuncture", "Type": "OTHER", "Description": "Acupuncture: the insertion of use of ultra-fine needles (diameter 0.18 - 0.30mm) into designated \"acupoints\" in the skin, along the limbs and trunk areas.\n\nReflexology: The massage + application of localized pressure on designated points along the plantar aspect of the feet.\n\nShiatsu: The application of localized pressure along designated points (similar to \"acupoints\") along the limbs and trunk areas.", "OtherNames": [ "Touch Therapy - reflexology or Shiatsu" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "The Chaim Sheba Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04528680", "BriefTitle": "Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma", "OfficialTitle": "Phase 1 / 2 Trial of Blood-brain Barrier Opening With an Implantable Ultrasound Device SonoCloud-9 and Treatment With Albumin-bound Paclitaxel and Carboplatin in Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-10-29", "PrimaryCompletionDate": "2025-11-30", "Interventions": [ { "Name": "Sonication for opening of blood-brain barrier", "Type": "DEVICE", "Description": "Implantation of SC-9 device and repeat activation of 9 ultrasound emitters during i.v. injection of microbubbles", "OtherNames": [ "SonoCloud-9 device, SC-9" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Chemotherapy, albumin-bound paclitaxel", "Type": "DRUG", "Description": "Intravenous infusion of ABX over 30 minutes", "OtherNames": [ "Abraxane®", "ABX" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Chemotherapy, carboplatin", "Type": "DRUG", "Description": "Intravenous infusion of carboplatin over 30 minutes", "OtherNames": [ "Paraplatin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "CarThera", "Bristol-Myers Squibb", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06059690", "BriefTitle": "Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells", "OfficialTitle": "Biologic Association Between Metabolic MR-PET and Tissue Measures of Glycolysis in Brain Tumors Visualization, Quantitation, and Targeting of Infiltrating Glioblastoma Cells With pH Sensitive Amine Chemical Exchange Saturation Transfer Magnetic Resonance Imaging-KL2TR001882", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-09-06", "PrimaryCompletionDate": "2027-09-30", "Interventions": [ { "Name": "pH Measurement of in vivo tissue", "Type": "DIAGNOSTIC_TEST", "Description": "The investigator will identify multiple (2-5) 5-8mm diameter spherical targets on GI maps for use in stereotactic pH measurement and biopsy acquisition. All biopsies are acquired for standard of care and according to standard of care procedures. A 13-gauge biopsy needle and plastic cannula will be inserted into the region of interest identified on MRI and PET. The biopsy needle will be removed, and the Softcell® pH probe, consisting of a 1.8mm diameter high quality glass tip and 1.6m long wire, will be guided down the cannula and inserted at least 15mm into the tissue. Recordings will be made for 1 minute to stabilize the reading, then the pH probe will be removed from the region of interest and placed into a saline vial for the next biopsy target. After the pH probe is removed, the biopsy needle will be placed into the cannula and standard-of-care biopsy tissue will be obtained from the same area where pH measurements were recorded.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Nitional institute of Health -National Center for Advancing Translational Sciences" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03330197", "BriefTitle": "A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG", "OfficialTitle": "A Phase I/II Study of Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Pediatric Brain Tumor Subjects", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-09-26", "PrimaryCompletionDate": "2021-09-10", "Interventions": [ { "Name": "Ad-RTS-hIL-12", "Type": "BIOLOGICAL", "Description": "2.0 x 10\\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Oral Veledimex - Arm 1 (Pediatric Brain Tumor)", "Type": "DRUG", "Description": "1 dose level (10mg/day) 15 oral daily doses of veledimex", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Oral Veledimex - Arm 2 (DIPG)", "Type": "DRUG", "Description": "2 dose levels (10mg/day, 20mg/day) 14 oral daily doses of veledimex", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alaunos Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00515086", "BriefTitle": "Study of Everolimus (RAD001) in Patients With Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2007-08", "PrimaryCompletionDate": "2009-08", "Interventions": [ { "Name": "Everolimus", "Type": "DRUG", "Description": "Tablets taken once a day with a full glass of water.", "OtherNames": [ "RAD001" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Surgery", "Type": "PROCEDURE", "Description": "Salvage surgical resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT00615927", "BriefTitle": "Phase II Imatinib + Hydroxyurea in Treatment of Patients With Recurrent/Progressive Grade II Low-Grade Glioma (LGG)", "OfficialTitle": "Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent / Progressive Grade II Low-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-02", "PrimaryCompletionDate": "2009-04", "Interventions": [ { "Name": "Imatinib Mesylate & Hydroxyurea", "Type": "DRUG", "Description": "Imatinib administered orally on daily. Imatinib is local irritant \\& must be taken in sitting position; mini of 2hrs should be allowed between last drug intake \\& going to bed. Imatinib doses 400mg/600mg administered once daily, whereas daily doses of 800mg/\\> administered as equally divided dose taken twice day. Dose for imatinib: Pts not receiving p450-inducing antiepileptic drugs: 400 mg/day. Pts receiving p450-inducing antiepileptic drugs: 500 mg twice day. It is recommended that pts take their prescribed imatinib mesylate at same time that they take their prescribed hydroxyurea, however, 30-60min interval between agents is acceptable if required for practical/other compliance issues.\n\nHydroxyurea administered orally twice day. Dosing will begin on day 1 of cycle 1 \\& continue daily. Drug is approximately 80 percent bioavailable. Dose will be 500mg twice day for all pts.", "OtherNames": [ "Imatinib Mesylate-Gleevec", "Hydroxyurea-Droxia-Hydrea-Hydroxycarbamide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03743662", "BriefTitle": "Nivolumab With Radiation Therapy and Bevacizumab for Recurrent MGMT Methylated Glioblastoma", "OfficialTitle": "A Phase II Trial of the PD-1 Antibody Nivolumab in Combination With Hypofractionated Re-irradiation and Bevacizumab for Recurrent MGMT Methylated Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2018-11-12", "PrimaryCompletionDate": "2026-11", "Interventions": [ { "Name": "Re-irradiation (RT)", "Type": "RADIATION", "Description": "Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further bevacizumab doses can be given every two weeks at the discretion of the treating physician.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.\n\nNivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radiation and bevacizumab for safety considerations to reduce adverse events. Single agent nivolumab will be given at 240mg flat dose every 2 weeks thereafter until disease progression, withdrawal, adverse event, or death.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Re-resection", "Type": "PROCEDURE", "Description": "Re-resection will be performed in the surgical arm at day 14 (+/- 5 days).", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06241391", "BriefTitle": "Ga-68 Prostate Specific Membrane Antigen PET/CT in Gliomas", "OfficialTitle": "Role of Ga-68 Prostate Specific Membrane Antigen PET/CT in Detection of Recurrence in Patients With Gliomas", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-02", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "PSMA PET-CT", "Type": "DIAGNOSTIC_TEST", "Description": "Prostate Specific Membrane Antigen PET-CT", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "All India Institute of Medical Sciences, Bhubaneswar", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03174197", "BriefTitle": "Atezolizumab in Combination With Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (aPDL1) in Combination With Temozolomide and Radiation in Patients With Newly Diagnosed Glioblastoma (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2017-06-30", "PrimaryCompletionDate": "2025-09-17", "Interventions": [ { "Name": "Atezolizumab", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "MPDL 3280A", "MPDL 328OA", "MPDL-3280A", "MPDL3280A", "MPDL328OA", "RG7446", "RO5541267", "Tecentriq" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo RT", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "Irradiated", "irradiation", "Radiation", "Radiotherapeutics", "RADIOTHERAPY", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PD-L1" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-L1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-L1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06640582", "BriefTitle": "TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas", "OfficialTitle": "Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab Immunotherapy in Patients With Advanced Brain Cancer Including Gliomas and Meningiomas", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-10-20", "PrimaryCompletionDate": "2026-09-10", "Interventions": [ { "Name": "Tumor Infiltrating Lymphocytes (TIL)", "Type": "BIOLOGICAL", "Description": "Tumor Infiltrating Lymphocytes (TIL) IV", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Fludarabine", "Type": "DRUG", "Description": "Fludarabine will be administered as an intravenous (IV) infusion for five days.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Interleukin-2", "Type": "DRUG", "Description": "After TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Intravenous (IV) infusion", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Essen Biotech", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT00107003", "BriefTitle": "GW572016 to Treat Recurrent Malignant Brain Tumors", "OfficialTitle": "A Biomarker and Phase II Study of GW572016 in Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-03-30", "PrimaryCompletionDate": "2007-12-05", "Interventions": [ { "Name": "lapatinib ditosylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Neoadjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00848523", "BriefTitle": "Study of LBH589 (Panobinostat) to Treat Malignant Brain Tumors", "OfficialTitle": "Phase II Trial of LBH589 (Panobinostat) in Adult Patients With Recurrent Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2008-11", "PrimaryCompletionDate": "2009-04", "Interventions": [ { "Name": "Panobinostat", "Type": "DRUG", "Description": "30 mg, three times a week, patients will continue with treatment until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.", "OtherNames": [ "LBH589" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Neurological Surgery, P.C.", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": null, "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01165632", "BriefTitle": "Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma", "OfficialTitle": "A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2010-07-26", "PrimaryCompletionDate": "2013-11-05", "Interventions": [ { "Name": "biopsy", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "biopsies" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "computed tomography", "Type": "PROCEDURE", "Description": "Undergo computed tomography", "OtherNames": [ "tomography, computed" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo stereotactic craniotomy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy treatment planning/simulation", "Type": "RADIATION", "Description": "Undergo radiation therapy treatment planning/simulation", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Undergo magnetic resonance imaging", "OtherNames": [ "MRI", "NMR imaging", "NMRI", "nuclear magnetic resonance imaging" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "positron emission tomography", "Type": "PROCEDURE", "Description": "Undergo positron emission tomography", "OtherNames": [ "FDG-PET", "PET", "PET scan", "tomography, emission computed" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "fluorine F 18 fluorodopa", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "(18)F-FDOPA", "18F-6- L-fluorodopa", "18F-DOPA", "18F-FDOPA" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01131234", "BriefTitle": "Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors", "OfficialTitle": "A Phase 1, Pharmacokinetic and Pharmacodynamic Study of the Combination of RO4929097 and Cediranib in Patients With Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-05", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "Gamma-Secretase Inhibitor RO4929097", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "RO4929097" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Cediranib Maleate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "AZD2171", "Recentin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05798507", "BriefTitle": "Identification of Treatment Concentrations of Defactinib or VS-6766 for the Treatment of Patients With Glioblastoma", "OfficialTitle": "A Single-Dose Study of Orally Administrated Defactinib or VS-6766 in Patients With Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2023-07-28", "PrimaryCompletionDate": "2026-12-03", "Interventions": [ { "Name": "Avutometinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CH-5126766", "CH5126766", "CKI-27", "R-7304", "Raf/MEK Inhibitor VS-6766", "RG 7304", "RG-7304", "RG7304", "RO5126766", "VS 6766", "VS-6766", "VS6766" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo blood and tissue sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Defactinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Verastem, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MEK", "MET" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00112736", "BriefTitle": "Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma", "OfficialTitle": "Phase I/II Study of OSI-774 (Erlotinib) and CCI-779 (Temsirolimus) in Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2005-04", "PrimaryCompletionDate": "2010-04", "Interventions": [ { "Name": "erlotinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CP-358,774", "erlotinib hydrochloride", "OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "temsirolimus", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CCI-779", "cell cycle inhibitor 779", "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor", "Kinase inhibitor" ] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT00002754", "BriefTitle": "Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors", "OfficialTitle": "PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1993-02", "PrimaryCompletionDate": "2001-04", "Interventions": [ { "Name": "monoclonal antibody Me1-14 F(ab')2", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02685605", "BriefTitle": "Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Multicenter Randomized Phase III Trial on INTraoperative RAdiotherapy in Newly Diagnosed GliOblastoma Multiforme (INTRAGO II)", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2016-12-09", "PrimaryCompletionDate": "2025-11", "Interventions": [ { "Name": "Standard surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Intraoperative radiotherapy", "Type": "RADIATION", "Description": "Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.", "OtherNames": [ "IORT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiochemotherapy", "Type": "RADIATION", "Description": "EBRT to 60 Gy plus 75 mg/m2/d temozolomide", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Universitätsmedizin Mannheim", "LeadSponsorClass": "OTHER", "Collaborators": [ "Carl Zeiss Meditec AG", "University of California, Los Angeles" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01017653", "BriefTitle": "Panitumumab and Irinotecan for Malignant Gliomas", "OfficialTitle": "Phase II Study of Panitumumab in Combination With Irinotecan for Malignant Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2010-02", "PrimaryCompletionDate": "2011-10", "Interventions": [ { "Name": "Irinotecan", "Type": "DRUG", "Description": "Irinotecan: for those patients on an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. For those not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.", "OtherNames": [ "Camptosar", "CPT-11" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Panitumumab", "Type": "DRUG", "Description": "Panitumumab, 6 mg/kg, as an intravenous infusion every other week. Treatment on both drugs will continue until tumor progression or unacceptable toxicity.", "OtherNames": [ "Vectibix" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Amgen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01342757", "BriefTitle": "Magnetic Resonance Spectroscopy Imaging in Predicting Response to Vorinostat and Temozolomide in Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "Using Proton Magnetic Resonance Spectroscopy (MRS) to Predict Response of Vorinostat Treatment in Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2012-05", "Interventions": [ { "Name": "vorinostat", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "L-001079038", "SAHA", "suberoylanilide hydroxamic acid", "Zolinza" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "magnetic resonance spectroscopic imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "1H-nuclear magnetic resonance spectroscopic imaging", "Proton Magnetic Resonance Spectroscopic Imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "survey administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04717999", "BriefTitle": "Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2021-09-01", "PrimaryCompletionDate": "2023-09-30", "Interventions": [ { "Name": "NKG2D CAR-T", "Type": "BIOLOGICAL", "Description": "The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T.", "OtherNames": [ "UWN2D" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "UWELL Biopharma", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05074992", "BriefTitle": "A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2022-08-24", "PrimaryCompletionDate": "2023-05-02", "Interventions": [ { "Name": "Ipilimumab", "Type": "DRUG", "Description": "Ipilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4" ], "classes": [] } } ], "LeadSponsorName": "University College, London", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "CTLA-4" ], "classes": [] } }, { "NCTId": "NCT01607905", "BriefTitle": "Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer", "OfficialTitle": "A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export/SINE Compound KPT-330 in Patients With Advanced or Metastatic Solid Tumor Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-06-18", "PrimaryCompletionDate": "2016-03-15", "Interventions": [ { "Name": "Selinexor", "Type": "DRUG", "Description": "Participants in this study will receive selinexor orally at dose levels specified for their respective dose cohorts. Dosing will begin at 3 mg/m\\^2 twice a week and will escalate until the MTD or RP2D is determined. Cycles will be repeated in 4-week (28 days for schedule 1 to 7) and 3-week (21 days for schedule 8) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.", "OtherNames": [ "KPT-330", "XPOVIO" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Acetaminophen", "Type": "DRUG", "Description": "Oral 500 mg (in Cycle 1, Week 1) to 1000 mg (in Cycle 1, Week 2 and onwards) of acetaminophen will be administered 1 hour prior to each selinexor dose up to 8 doses per cycle (28 days per cycle)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Karyopharm Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03750071", "BriefTitle": "VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma", "OfficialTitle": "An Open-label, Phase I/II Multicenter Clinical Trial of VXM01 in Combination With Avelumab in Patients With Progressive Glioblastoma Following Standard Treatment, With or Without Second Surgery", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2018-11-21", "PrimaryCompletionDate": "2021-12-31", "Interventions": [ { "Name": "VXM01", "Type": "BIOLOGICAL", "Description": "Ty21a transformed with a eukaryotic VEGFR-2 Expression Plasmid", "OtherNames": [ "Investigational VEGFR-2 DNA Vaccine" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR", "PD-L1", "VEGF" ], "classes": [] } }, { "Name": "Avelumab", "Type": "BIOLOGICAL", "Description": "Monoclonal anti-PD-L1 Antibody", "OtherNames": [ "Bavencio" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Vaximm GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Merck KGaA, Darmstadt, Germany", "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR", "PD-L1", "VEGF" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT01700569", "BriefTitle": "Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma", "OfficialTitle": "Phase I Study of Escalated Pharmacologic Dose, of Oral Folinic Acid in Combination With Temozolomide, According to Stupp R. Regimen, in Patients With Operated Grade-IV Astocytoma and a Non-methylated Gene Status of MGMT.", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2013-01", "PrimaryCompletionDate": "2019-12-12", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "All the Patients are treated by oral Temozolomide 75 mg/m²/day every day during 42 days, 30 minutes after Folinic acid and 120 min before the radiation dose to the brain tumor. After one month rest, the maintenance phase consists of:Temozolomide is given orally (30 min after Folinic acid), at 200 mg/m²/day every day during 5 days: one course every month during 6 months (6 maintenance course).", "OtherNames": [ "Temodal", "capsule dosage available: 5, 20, 10, 180 and 250 mg" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "folinic acid at pharmacological dose is the escalated drug", "Type": "DRUG", "Description": null, "OtherNames": [ "Folinate de Calcium, Lederfoline" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "High voltage radiation therapy (linear accelerator)", "Type": "RADIATION", "Description": "Brain tumor field is irradiated Five days a week, during Stupp regimen during 6 weeks. During the sams time, Folinic acid and Temozolomide are given orally every days (six weeks).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Institut Cancerologie de l'Ouest", "LeadSponsorClass": "OTHER", "Collaborators": [ "Centre Antoine Lacassagne", "Hospices Civils de Lyon" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07089641", "BriefTitle": "ERAS-801 for the Treatment of Resectable and Progressive or Recurrent IDH Wildtype Grade IV Glioblastoma or Astrocytoma With an EGFR Amplification or Mutation, ERAS801-SARG Trial", "OfficialTitle": "A Phase Ib Open Label Clinical Trial to Evaluate the Safety and Efficacy of ERAS-801 in Surgically Accessible Recurrent Glioblastoma Patients With EGFR Amplification or Mutation (ERAS801-SARG)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-28", "PrimaryCompletionDate": "2027-07-30", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo urine, blood, and CSF sample collection", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "Echocardiography Test", "Type": "PROCEDURE", "Description": "Undergo ECHO", "OtherNames": [ "EC", "Echocardiography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "EGFR Inhibitor ERAS-801", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "ERAS 801", "ERAS-801", "ERAS801" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "Fludeoxyglucose F-18", "Type": "OTHER", "Description": "Given FDG", "OtherNames": [ "18FDG", "FDG", "Fludeoxyglucose (18F)", "fludeoxyglucose F 18", "Fludeoxyglucose F18", "Fluorine-18 2-Fluoro-2-deoxy-D-Glucose", "Fluorodeoxyglucose F18" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo brain MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo FDG PET", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron emission tomography (procedure)", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "PT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "Name": "Surgical Procedure", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Operation", "Surgery", "Surgery Type", "Surgery, NOS", "Surgical", "Surgical Intervention", "Surgical Interventions", "Surgical Procedures", "Type of Surgery" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "EGFR", "IDH" ], "classes": [] } }, { "NCTId": "NCT00301418", "BriefTitle": "Oral Tarceva Study for Recurrent/Residual Glioblastoma Multiforme and Anaplastic Astrocytoma", "OfficialTitle": "Phase I/II Trial of Oral Erlotinib (Tarceva, OSI-774) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-03", "PrimaryCompletionDate": "2014-05", "Interventions": [ { "Name": "Erlotinib", "Type": "DRUG", "Description": "Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.", "OtherNames": [ "Tarceva", "OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01128218", "BriefTitle": "A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors", "OfficialTitle": "A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-03", "PrimaryCompletionDate": "2021-02", "Interventions": [ { "Name": "Tumor fluorescence", "Type": "DRUG", "Description": "Oral doses in phase 1 study of 10mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg.\n\nRecommended oral dose of phase 1 will be used in phase 2", "OtherNames": [ "5-ALA", "5-aminolevulinic acid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Southern Illinois University", "LeadSponsorClass": "OTHER", "Collaborators": [ "DUSA Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00643097", "BriefTitle": "Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Complementary Trial of an Immunotherapy Vaccine Against Tumor-Specific EGFRvIII", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-09", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "PEP-3 vaccine", "Type": "BIOLOGICAL", "Description": "Given intradermally", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "sargramostim", "Type": "BIOLOGICAL", "Description": "Given intradermally", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Standard of care chemotherapy", "OtherNames": [ "TMZ", "Temodar" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "John Sampson", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institute of Neurological Disorders and Stroke (NINDS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01754350", "BriefTitle": "Calorie-restricted, Ketogenic Diet and Transient Fasting During Reirradiation for Patients With Recurrent Glioblastoma", "OfficialTitle": "Calorie-restricted, Ketogenic Diet and Transient Fasting vs. Standard Nutrition During Reirradiation for Patients With Recurrent Glioblastoma: the ERGO2 Study", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2013-05", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "calorie-restricted ketogenic diet and transient fasting", "Type": "DIETARY_SUPPLEMENT", "Description": "On day 1-3 and day 7-9, restriction of carbohydrates to \\< 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by \"Tavarlin\".", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "standard nutrition", "Type": "DIETARY_SUPPLEMENT", "Description": "nutrition as recommended by the german society for nutrition, 30 kcal/kg per day", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Johann Wolfgang Goethe University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Tavarlin" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00003475", "BriefTitle": "Antineoplaston Therapy in Treating Patients With Primary Malignant Brain Tumors", "OfficialTitle": "Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Primary Malignant Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1996-02", "PrimaryCompletionDate": "2011-05", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).\n\nThe daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04197934", "BriefTitle": "WSD0922-FU for the Treatment of Glioblastoma, Anaplastic Astrocytoma, or Non-small Cell Lung Cancer With Central Nervous System Metastases", "OfficialTitle": "Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of WSD0922-FU", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-12-20", "PrimaryCompletionDate": "2022-10-30", "Interventions": [ { "Name": "Biospecimen Collection - blood samples", "Type": "PROCEDURE", "Description": "Undergo collection of blood samples", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Biospecimen Collection", "Specimen Collection" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Biospecimen Collection - CSF samples", "Type": "PROCEDURE", "Description": "Undergo collection of CSF samples", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Biospecimen Collection", "Specimen Collection" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo CT", "OtherNames": [ "CAT", "CAT Scan", "Computed Axial Tomography", "Computerized Axial Tomography", "Computerized axial tomography (procedure)", "Computerized Tomography", "CT", "CT Scan", "tomography" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "EGFR/EGFRvIII Inhibitor WSD0922-FU", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BBB Penetrable EGFR/EGFRvIII Inhibitor WSD0922-FU", "EGFR Mutant Inhibitor WSD0922-FU", "WSD 0922-FU", "WSD-0922-FU", "WSD0922-FU" ], "modality": [ "Other" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [ "Food and Drug Administration (FDA)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [] } }, { "NCTId": "NCT00005952", "BriefTitle": "Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors", "OfficialTitle": "A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2000-08", "PrimaryCompletionDate": "2005-11", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00107185", "BriefTitle": "Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma", "OfficialTitle": "Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas in Pediatric Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-01", "PrimaryCompletionDate": "2009-10", "Interventions": [ { "Name": "therapeutic autologous dendritic cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04243005", "BriefTitle": "Supramarginal Resection in Glioblastoma", "OfficialTitle": "Supramarginal Resection in Patients With Glioblastoma: A Randomised Controlled Trial", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2020-07-01", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "Supramarginal resection", "Type": "PROCEDURE", "Description": "Aim of supramarginal resection, where a margin of at least 10 mm is considered feasible prior to surgery. The resection is guided by the T2 volume (i.e. zone of edema) where removal of as much as possible of this zone (or beyond) is attempted as long as considered safe", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Conventional surgery", "Type": "PROCEDURE", "Description": "Aim of gross total resection (i.e. removal of contrast enhancing tumor) according to institutional practice. No limit in use of technical adjuncts in this arm.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "St. Olavs Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Odense University Hospital", "Sahlgrenska University Hospital", "Turku University Hospital", "Karolinska University Hospital", "Norwegian University of Science and Technology", "Uppsala University Hospital", "University Hospital, Umeå", "Haukeland University Hospital", "Ullevaal University Hospital", "Rikshospitalet University Hospital", "Tampere University Hospital", "Helsinki University Central Hospital", "Kuopio University Hospital", "Oulu University Hospital", "Medical University of Vienna", "Paracelsus Medical University", "Medical Center Haaglanden, The Hague, The Netherlands", "Erasmus Medical Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05970757", "BriefTitle": "Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma", "OfficialTitle": "Physiological MRI for Precision Radiotherapy IDH-wildtype Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-07-14", "PrimaryCompletionDate": "2023-12-15", "Interventions": [ { "Name": "Extended MRI", "Type": "DIAGNOSTIC_TEST", "Description": "Extension of the brain tumor MRI-protocol", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [] } } ], "LeadSponsorName": "Erasmus Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [] } }, { "NCTId": "NCT00430911", "BriefTitle": "Radiotherapy for Malignant Astrocytomas in the Elderly", "OfficialTitle": null, "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2001-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Radiotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01434602", "BriefTitle": "Phase I-II Everolimus and Sorafenib in Recurrent High-Grade Gliomas", "OfficialTitle": "A Phase I-II Trial of Everolimus and Sorafenib in Patients With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-10-02", "PrimaryCompletionDate": "2020-10-19", "Interventions": [ { "Name": "everolimus", "Type": "DRUG", "Description": "Patients will be treated with daily everolimus (days 1-28) in combination with sorafenib; There is not a defined set maximum number of cycles that a patient may have; Phase I Dose Escalation: 5mg to 10mg daily.", "OtherNames": [ "Zortress" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "sorafenib", "Type": "DRUG", "Description": "Patients will be treated with sorafenib in combination with everolimus (days 1-28); There is not a defined set maximum number of cycles that a patient may have; Phase I Dose Escalation 400mg-600mg twice a day (bid) or 400mg-800mg twice a day, 7 days on and 7 days off.", "OtherNames": [ "Nexavar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [] } }, { "NCTId": "NCT06672575", "BriefTitle": "A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma", "OfficialTitle": "A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2025-01-30", "PrimaryCompletionDate": "2028-01-31", "Interventions": [ { "Name": "Ivonescimab", "Type": "DRUG", "Description": "Participante will recived an infusion by vein", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Summit Therapeutics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07029100", "BriefTitle": "Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.", "OfficialTitle": "Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-07-01", "PrimaryCompletionDate": "2027-07-01", "Interventions": [ { "Name": "Ex-vivo organoid culture", "Type": "OTHER", "Description": "ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Centre Henri Becquerel", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02142803", "BriefTitle": "TORC1/2 Inhibitor MLN0128 and Bevacizumab in Treating Patients With Recurrent Glioblastoma or Advanced Solid Tumors", "OfficialTitle": "A Phase 1 Study of MLN0128 and Bevacizumab in Patients With Recurrent Glioblastoma and Other Solid Tumors", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2014-05-20", "PrimaryCompletionDate": "2020-12-31", "Interventions": [ { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "ABP 215", "ABP-215", "ABP215", "Alymsys", "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF Monoclonal Antibody SIBP04", "Anti-VEGF rhuMAb", "Avastin", "Avzivi", "Aybintio", "BAT 1706", "BAT-1706", "BAT1706", "BAT1706 Biosimilar", "Bevacizumab awwb", "Bevacizumab Biosimilar ABP 215", "Bevacizumab Biosimilar BAT1706", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar CT-P16", "Bevacizumab Biosimilar FKB238", "Bevacizumab Biosimilar GB-222", "Bevacizumab Biosimilar HD204", "Bevacizumab Biosimilar HLX04", "Bevacizumab Biosimilar IBI305", "Bevacizumab Biosimilar LY01008", "Bevacizumab Biosimilar MB02", "Bevacizumab Biosimilar MIL60", "Bevacizumab Biosimilar Mvasi", "Bevacizumab Biosimilar MYL-1402O", "Bevacizumab Biosimilar QL 1101", "Bevacizumab Biosimilar QL1101", "Bevacizumab Biosimilar RPH-001", "Bevacizumab Biosimilar SCT501", "Bevacizumab Biosimilar Zirabev", "Bevacizumab-adcd", "Bevacizumab-awwb", "Bevacizumab-aybi", "Bevacizumab-bvzr", "Bevacizumab-equi", "Bevacizumab-maly", "Bevacizumab-onbe", "Bevacizumab-tnjn", "BP102", "BP102 Biosimilar", "CT P16", "CT-P16", "CTP16", "Equidacent", "FKB 238", "FKB-238", "FKB238", "HD204", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "MB 02", "MB-02", "MB02", "Mvasi", "MYL-1402O", "Onbevzi", "Oyavas", "PF 06439535", "PF-06439535", "PF06439535", "QL1101", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF", "SCT501", "SIBP 04", "SIBP-04", "SIBP04", "Vegzelma", "Zirabev" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Sapanisertib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "INK-128", "INK128", "MLN-0128", "MLN0128", "TAK-228" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06797661", "BriefTitle": "Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients with Brain Lesions.", "OfficialTitle": "Insights Into the Pathophysiology of Neurovascular Uncoupling in Patients with Brain Lesions.", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-02-17", "PrimaryCompletionDate": "2026-06-01", "Interventions": [ { "Name": "Functional MRI", "Type": "DIAGNOSTIC_TEST", "Description": "11 minutes of Functional MRI alternating breathing Air-Room and gaz mix (5%CO2 21%O2 74%N2).\n\nAll procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "FDG-PET", "Type": "DIAGNOSTIC_TEST", "Description": "Some patients who did not benefit from a FDG-PET in their clinical evaluation or more than 1 month before the inclusion in the present study will be ask to also undergo a brain FDG-PET , the dose is set at 2 Mega becquerel per Kg.\n\nAll procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Structural MRI", "Type": "DIAGNOSTIC_TEST", "Description": "Patient will benefit Different anatomical sequence of acquisition listed here : T1 , T1 with contrast agent (gadovist) , T2 flair , T2 and DSC (Dynamic susceptibility contrast) , and Time Of Flight .\n\nAll procedure are acquired simultaneously on a single acquisition on the PET/MRI camera in the institution.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Erasme University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05296122", "BriefTitle": "Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions", "OfficialTitle": "Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesion Using the Tranberg® Thermal Therapy System and Tranberg® Thermoguide Workstation", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2022-05-12", "PrimaryCompletionDate": "2024-08-30", "Interventions": [ { "Name": "TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation.", "Type": "DEVICE", "Description": "The main purpose with the study is to investigate safety and feasibility of the TRANBERG® laser applicators when used in MR-guided laser thermal ablation of brain lesions using the TRANBERG® Thermal Therapy System and TRANBERG® Thermoguide Workstation together with SmartTwist™ MR Hand Drill with the SmartTip™ MR Drill Kit for MR-guided laser thermal ablation of brain lesions.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Clinical Laserthermia Systems AB", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DEVICE_FEASIBILITY", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00357253", "BriefTitle": "Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma", "OfficialTitle": "A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2006-01", "PrimaryCompletionDate": "2010-03", "Interventions": [ { "Name": "capecitabine", "Type": "DRUG", "Description": "This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.", "OtherNames": [ "Xeloda" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04933422", "BriefTitle": "CM93 Treatment in Subjects With Epidermal Growth Factor Receptor (EGFR)-Modified Recurrent Glioblastoma (rGBM)", "OfficialTitle": "Phase 1 Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Effects of CM93 in Subjects With Recurrent Glioblastoma (rGBM) Characterized by Epidermal Growth Factor Receptor (EGFR) Mutation or Amplification", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2027-01", "PrimaryCompletionDate": "2029-07", "Interventions": [ { "Name": "CM93", "Type": "DRUG", "Description": "oral capsule of CM93 administered once daily", "OtherNames": [ "N-(5-((4-(1H-pyrrolo[2,3-b]pyridin-1-yl)pyrimidin-2-yl)amino)-2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxyphenyl)acrylamide 4-methylbenzenesulfonate" ], "modality": [ "Other" ], "moa": { "targets": [ "EGFR", "MET" ], "classes": [] } } ], "LeadSponsorName": "Crimson Biopharm Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR", "MET" ], "classes": [] } }, { "NCTId": "NCT04019002", "BriefTitle": "Hyperpolarized Carbon-13 (13C) Pyruvate Imaging in Patients With Glioblastoma", "OfficialTitle": "Evaluating Hyperpolarized and Proton Brain Metabolism in Patients With Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2019-11-19", "PrimaryCompletionDate": "2025-09-30", "Interventions": [ { "Name": "Hyperpolarized 13C Pyruvate", "Type": "DRUG", "Description": "Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution via intravenous injection over a period of about 1 minute once prior to each research magnetic resonance imaging procedure.", "OtherNames": [ "HP-13C" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Susan Chang", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT03532295", "BriefTitle": "Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas", "OfficialTitle": "Safety and Efficacy Study of Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2020-04-20", "PrimaryCompletionDate": "2024-07-26", "Interventions": [ { "Name": "Epacadostat", "Type": "DRUG", "Description": "-All BID doses will be taken in the morning and evening, approximately 12 hours apart", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "-The first infusion will be over the course of 90 minutes; if tolerated, the second infusion will be over the course of 60 minutes; if tolerated, all subsequent infusions will be over 30 minutes", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "-The gross tumor maximum diameter (to be irradiated) to be \\50 Gy to brain, \\>45 Gy to spine).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will be taken by mouth once daily, on days 1-5 of each chemo-immunotherapy treatment cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Cyclophosphamide", "Type": "DRUG", "Description": "Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Etoposide", "Type": "DRUG", "Description": "Etoposide will be taken by mouth once daily, on days 1-21 of each chemo-immunotherapy treatment cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "Lomustine will be taken by mouth once daily, on day 1 of each chemo-immunotherapy treatment cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Theodore S. Johnson", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Augusta University", "Emory University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "CROSSOVER", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00584883", "BriefTitle": "A Phase I Study of ABT 510 for Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase I Study of ABT 510 and Concurrent Temozolomide and Radiotherapy for Patients With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2003-08", "PrimaryCompletionDate": "2008-07", "Interventions": [ { "Name": "ABT 510", "Type": "DRUG", "Description": "ABT 510 (TSP-1 mimetic peptide) is a parenterally available nonapeptide analog of the heptapeptide and is a potent inhibitor of angiogenesis. ABT 510 competes with TSP-1 for binding to endothelial cells, but the exact mechanism of anti-angiogenesis is unknown. ABT 510 is administered by SQ injection. The starting dose of ABT 510 will be 20mg once daily (QD) SQ. Doses will be escalated by approximately 50% increments in consecutive cohorts of 3-6 patients until maximum tolerated dose is achieved.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07193654", "BriefTitle": "Stupp Treatment With Intrathecal Injection of Thiotepa for Glioblastoma With Advanced Spread", "OfficialTitle": "Stupp Regimen Combined With Intrathecal Injection of Thiotepa for the Treatment of Glioblastoma With Ventricular Invasion or Meningeal Metastasis：a Prospective, Single-Arm, Exploratory Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2025-04-01", "PrimaryCompletionDate": "2027-04-01", "Interventions": [ { "Name": "Intrathecal injection of thiotepa", "Type": "DRUG", "Description": "Intrathecal injection of thiotepa: Administered via lumbar puncture or OMMAYA reservoir according to the study protocol.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Stupp regimen (oral temozolomide)", "Type": "DRUG", "Description": "Stupp regimen (oral temozolomide)::75 mg/m² daily during radiotherapy; 150-200 mg/m² daily for 5 days every 28 days for 6 cycles after radiotherapy;", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radical radiotherapy", "Type": "RADIATION", "Description": "Radical radiotherapy: Delivery of 60 Gy of radiation, typically divided into 30 fractions of 2 Gy each;", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "Maximal surgical resection", "Type": "PROCEDURE", "Description": "Maximal surgical resection: Removal of as much tumor as possible while preserving neurological function;", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Second Affiliated Hospital, School of Medicine, Zhejiang University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06157541", "BriefTitle": "T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase I/II Clinical Trial of Allogeneic Cytomegalovirus-specific T Cells in Combination With Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-02-08", "PrimaryCompletionDate": "2026-04", "Interventions": [ { "Name": "Allogeneic cytomegalovirus-specific T cells", "Type": "BIOLOGICAL", "Description": "Allogeneic cytomegalovirus (CMV)-specific T cells generated from the blood of healthy CMV-seropositive donors", "OtherNames": [ "CYT-101" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "A humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) specific for the programmed cell death 1 (PD-1) receptor", "OtherNames": [ "Keytruda" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Queensland Institute of Medical Research", "LeadSponsorClass": "OTHER", "Collaborators": [ "CUREator", "Merck Sharp & Dohme LLC", "The Newro Foundation", "Royal Brisbane and Women's Hospital", "Princess Alexandra Hospital, Brisbane, Australia", "Austin Hospital, Melbourne Australia" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT04165941", "BriefTitle": "Novel Gamma-Delta (γδ)T Cell Therapy for Treatment of Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I Study of Drug Resistant Immunotherapy (DRI) With Activated, Gene Modified γδ T Cells in Patients With Newly Diagnosed Glioblastoma Multiforme Receiving Maintenance Temozolomide Chemotherapy", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-02-11", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "DRI cell therapy", "Type": "BIOLOGICAL", "Description": "Drug Resistant Immunotherapy with gamma delta modified T cells to be resistance to temozolomide will be infused into the surgical cavity following the completion of standard concurrent radiation and chemotherapy with temozolomide.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00884741", "BriefTitle": "Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2009-04-15", "PrimaryCompletionDate": "2013-03-17", "Interventions": [ { "Name": "3-Dimensional Conformal Radiation Therapy", "Type": "RADIATION", "Description": "Undergo 3-dimentional conformal radiation therapy", "OtherNames": [ "3-dimensional radiation therapy", "3D CONFORMAL RADIATION THERAPY", "3D CRT", "3D-CRT", "Conformal Therapy", "Radiation Conformal Therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Anti-VEGF", "Anti-VEGF Humanized Monoclonal Antibody", "Anti-VEGF rhuMAb", "Avastin", "Bevacizumab Biosimilar BEVZ92", "Bevacizumab Biosimilar BI 695502", "Bevacizumab Biosimilar CBT 124", "Bevacizumab Biosimilar FKB238", "BEVACIZUMAB, LICENSE HOLDER UNSPECIFIED", "Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer", "Recombinant Humanized Anti-VEGF Monoclonal Antibody", "rhuMab-VEGF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Intensity-Modulated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo intensity-modulated radiation therapy", "OtherNames": [ "IMRT", "Intensity Modulated RT", "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Placebo", "Type": "OTHER", "Description": "Given IV", "OtherNames": [ "placebo therapy", "PLCB", "sham therapy" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [ "Radiation Therapy Oncology Group", "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05868083", "BriefTitle": "The Safety and Efficacy of SNC-109 CAR-T Cells Therapy the Recurrent Glioblastoma", "OfficialTitle": "A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of SNC-109 CAR-T Cell Therapy in Subjects With Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2022-06-24", "PrimaryCompletionDate": "2024-05", "Interventions": [ { "Name": "SNC-109 CAR-T Cells", "Type": "DRUG", "Description": "SNC-109 CAR-T Cells, first dose from 2×104 CAR+ T Cells, treatment follows the operation and the next dose would be deiced by SRC", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shanghai Simnova Biotechnology Co.,Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Chinese PLA General Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06329570", "BriefTitle": "Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)", "OfficialTitle": "A Prospective, Open-Label, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2024-07-01", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "NaviFUS System", "Type": "DEVICE", "Description": "Open the BBB using focused ultrasound and microbubble", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Lumason", "Type": "DRUG", "Description": "Open the BBB using focused ultrasound and microbubble", "OtherNames": [ "SonoVue" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "An anti-angiogenic agent to block tumor growth", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "NaviFUS Corporation", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "NaviFUS US LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00068770", "BriefTitle": "Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT", "OfficialTitle": "A Pharmacokinetic Study of the Interaction Between Celecoxib and Anticonvulsant Drugs in Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Radiation Therapy", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2003-10", "PrimaryCompletionDate": "2005-05", "Interventions": [ { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment", "OtherNames": [ "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Celecoxib", "Type": "DRUG", "Description": "Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2 doses will be administered at least 12 hours apart. Celecoxib will continue throughout the 6 week course of RT.", "OtherNames": [ "Cox2" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04614493", "BriefTitle": "Innovative SonoCloud-9 Device for Blood Brain Barrier Opening in First Line Temozolomide Glioblastoma Patients.", "OfficialTitle": "Multisite Open-label Randomized Phase II Clinical Trial in Newly Diagnosed Glioblastoma Treated by Concurrent Temoradiation and Adjuvant Temozolomide +/- Ultrasound-induced Blood Brain Barrier Opening.", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-09-11", "PrimaryCompletionDate": "2024-03", "Interventions": [ { "Name": "SonoCloud-9 (SC9) device", "Type": "DEVICE", "Description": "daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) with 6 concomitant Blood Brain Barrier opening sessions by ultrasound\n\n\\+ 9 Blood Brain Barrier opening sessions by ultrasound without any associated drug", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide according Stupp protocol", "Type": "DRUG", "Description": "daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Assistance Publique - Hôpitaux de Paris", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00795665", "BriefTitle": "Bevacizumab and Carmustine in Treating Patients With Relapsed or Progressive High-Grade Glioma", "OfficialTitle": "Phase II Study of Bevacizumab (Avastin) and BCNU for Treatment of Relapsed, High Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-06", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "bevacizumab", "Type": "DRUG", "Description": "Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "carmustine", "Type": "DRUG", "Description": "BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.", "OtherNames": [ "BCNU" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of California, Davis", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05635734", "BriefTitle": "Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined with Conventional Concurrent Radiation and Temozolomide in Patients with Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-09-05", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Azeliragon 5 mg", "Type": "DRUG", "Description": "Azeliragon 5 mg once a day (loading initial dose for 6 days of 10 mg daily). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.\n\nPatients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Azeliragon 10 mg", "Type": "DRUG", "Description": "Azeliragon 10 mg once a day (loading initial dose for 6 days of 15 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.\n\nPatients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Azeliragon 20 mg", "Type": "DRUG", "Description": "Azeliragon 20 mg once a day (loading initial dose for 6 days of 30 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.\n\nPatients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Cantex Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01812616", "BriefTitle": "A Safety Study of Sativex Compared With Placebo (Both With Dose-intense Temozolomide) in Recurrent Glioblastoma Patients", "OfficialTitle": "A Two Part Study to Assess the Tolerability, Safety and Pharmacodynamics of Sativex in Combination With Dose-intense Temozolomide in Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-09", "PrimaryCompletionDate": "2016-06", "Interventions": [ { "Name": "Sativex", "Type": "DRUG", "Description": "Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).", "OtherNames": [ "THC/CBD spray", "Nabiximols", "GW-1000-02" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and Food, Drugs \\& Cosmetics (FD\\&C)certified color additives; FD\\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).", "OtherNames": [ "Placebo comparator" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jazz Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02654964", "BriefTitle": "Cancer Stem Cell High-Throughput Drug Screening Study", "OfficialTitle": "A Phase 0/1 Study of Combination Drug Therapy For Glioblastoma Based on Personalized Cancer Stem Cell (CSC) High-Throughput Drug Screening (HTS)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-12", "PrimaryCompletionDate": "2021-11", "Interventions": [ { "Name": "Combination Drug Therapy", "Type": "DRUG", "Description": "Up to 3 of 73 possible interventions from the drug classes listed below will be selected based on their potency against CSCs, potential for synergy without cross-reactive toxicities, drug safety profiles, pharmacokinetics, and drug-drug interactions. Those patients that have GBM that has recurred (as defined by RANO (45)), and for whom HTS was successfully completed, will be eligible to continue to the treatment component of the study to receive the drug cocktail comprised from the following drug classes:\n\nAntineoplastic Anti-infective Antiemetic Antihyperlipidemic Anti-inflammatory Antihistamine Antihypertensive Antidepressant Cardiotonic Alcohol antagonist Diuretic Antipsychotic NMDA receptor antagonist Antidiabetic Immunosuppressant Anticonvulsant Antimethemoglobinemic Sclerosing agent", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Swedish Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00974987", "BriefTitle": "Boron Neutron Capture Therapy, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase II, Multicenter, Study for Newly Diagnosed Glioblastomas Using Boron Neutron Capture Therapy, Additional X-ray Treatment and Chemotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-09-01", "PrimaryCompletionDate": "2016-02-29", "Interventions": [ { "Name": "BNCT(boron neutron capture therapy)", "Type": "RADIATION", "Description": "BSH(sodium borocaptate) 100mg/kg iv for one hour starting 13 hours before irradiation, and BPA(p-boronophenylalanine) 500/mg/kg iv at a speed of 200mg/kg/hr for 2 hours starting 2 hours before irradiation. During irradiation, BPA iv continues at a speed of 100mg/kg/hr.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "XRT(X-ray radiation treatment)", "Type": "RADIATION", "Description": "After BNCT, 2Gy irradiation every day for 12 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TMZ(temozolomide)", "Type": "DRUG", "Description": "75mg/m2 for day1-12. After XRT, repeat the cycle of 150-200mg/m2 for 5 days and cessation for 23 days.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan", "LeadSponsorClass": "OTHER", "Collaborators": [ "Department of Nuerosurgery, Osaka Medical College" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01181193", "BriefTitle": "Vitamin D for Treatment of Glioblastoma Multiforme", "OfficialTitle": "High-Dose Vitamin D in Combination With Chemoradiotherapy in the Treatment of Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2011-03", "PrimaryCompletionDate": "2013-03", "Interventions": [ { "Name": "Surgery", "Type": "OTHER", "Description": "Craniotomy with total or partial removal of the brain tumor", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiotherapy to tumour bed and/or residual tumour", "Type": "RADIATION", "Description": "60 Gy in 30 fractions over 6 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "1. 75 mg/m2/day for entire period of radiotherapy\n2. 150-200 mg/m2/day for 5 days every 28 days, 6 cycles total", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Vitamin D3", "Type": "DRUG", "Description": "4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Soroka University Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03389802", "BriefTitle": "Phase I Study of APX005M in Pediatric Central Nervous System Tumors", "OfficialTitle": "Phase I Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Pediatric Subjects With Recurrent/Refractory Brain Tumors and Newly Diagnosed Brain Stem Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2018-03-01", "PrimaryCompletionDate": "2023-09-30", "Interventions": [ { "Name": "APX005M treatment for recurrent or refractory primary malignant CNS tumor patients", "Type": "BIOLOGICAL", "Description": "APX005M dosing will begin at 0.1 mg/kg, the APX005M dose may be increased (0.3, 0.45, 0.6 mg/kg) or decreased (0.03 mg/kg) in subsequent cohorts until the maximum tolerated dose (MTD) is reached or until dose level 3 (0.6 mg/kg) is complete without the MTD being defined.\n\nAPX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "APX005M treatment for newly diagnosed DIPG patients", "Type": "BIOLOGICAL", "Description": "The starting dose of APX005M for the DIPG patients will be one dose level below the recommended phase II dose (RP2D) determined in Stratum 1 patients. The dose may be decreased or increased to the RP2D established in Stratum 1.\n\nAPX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pediatric Brain Tumor Consortium", "LeadSponsorClass": "NETWORK", "Collaborators": [ "American Lebanese Syrian Associated Charities", "Pyxis Oncology, Inc", "Solving Kids' Cancer", "Ty Louis Campbell Foundation", "A Kids' Brain Tumor Cure Foundation", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00017264", "BriefTitle": "Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma", "OfficialTitle": "A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-06", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "atrasentan hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02120287", "BriefTitle": "Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Glioblastoma Multiforme", "OfficialTitle": "Multicenter Phase II Study of Border Zone Stereotactic Radiosurgery With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2018-03-31", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Magnetic Resonance Spectroscopy (MRS)", "Type": "PROCEDURE", "Description": "Subjects will have MRS prior to BZ-SRS.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Border Zone Stereotactic Radiosurgery (BZ-SRS)", "Type": "PROCEDURE", "Description": "The 'border zone' of the tumor will be targeted by SRS in a single session.", "OtherNames": [ "GammaKnife" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Ajay Niranjan", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04469075", "BriefTitle": "Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields", "OfficialTitle": "The PROTECT Study: A Phase II, Open-Label Trial of PROphylactic Skin Toxicity ThErapy With Clindamycin and Triamcinolone in Glioblastoma Patients Treated With Tumor Treating Fields", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2020-07-09", "PrimaryCompletionDate": "2026-07", "Interventions": [ { "Name": "Clindamycin Phosphate", "Type": "DRUG", "Description": "phosphate 1% solution triamcinolone 0.01% at every array change (or approved equivalent)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Triamcinolone Acetonide", "Type": "DRUG", "Description": "triamcinolone acetonide 0.01% lotion triamcinolone 0.01% at every array change", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00734864", "BriefTitle": "Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma", "OfficialTitle": "Phase I Study of Dasatinib Plus Protracted Temozolomide in Recurrent Malignant Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2010-06", "Interventions": [ { "Name": "enzyme-inducing anti-epileptic drugs", "Type": "DRUG", "Description": "Subjects taking EIAEDs (CYP3A enzyme-inducing anti-epileptic drugs Phenytoin/Dilantin, Fosphenytoin/Cerebyx, Phenobarbital, Primidone/Mysoline, Oxcarbazepine/Trileptal, Carbamazepine/Tegretol).", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "enzyme-inducing anti-epileptic drugs", "Type": "DRUG", "Description": "Subjects NOT taking EIAEDs (CYP-3A enzyme-inducing anti-epileptic drugs Phenytoin/Dilantin, Fosphenytoin/Cerebyx, Phenobarbital, Primidone/Mysoline, Oxcarbazepine/Trileptal, Carbamazepine/Tegretol).", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT04116411", "BriefTitle": "A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients", "OfficialTitle": "A Multicenter Randomized Double-blinded Controlled Phase 2 Study Evaluating the Efficacy of Valganciclovir as add-on Therapy in Glioblastoma Patients", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2019-09-04", "PrimaryCompletionDate": "2027-09-16", "Interventions": [ { "Name": "Valganciclovir Tablets", "Type": "DRUG", "Description": "Valganciclovir treatment of glioblastoma", "OtherNames": [ "Valcyte", "ValGANcilovir", "Valganciclovir 450 mg", "J05AB14", "Valganciclovir oral" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide 120 mg", "Type": "DRUG", "Description": "Chemotherapy", "OtherNames": [ "Temozolomide pill", "Temozolomide tablet" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy 60 Gy", "Type": "RADIATION", "Description": "Radiation therapy", "OtherNames": [ "Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Placebo oral tablet", "Type": "DRUG", "Description": "Placebo treatment of glioblastoma", "OtherNames": [ "Placebos" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Cecilia Soderberg-Naucler", "LeadSponsorClass": "OTHER", "Collaborators": [ "Karolinska University Hospital", "Karolinska Institutet" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01558687", "BriefTitle": "Cilengitide Imaging Trial in Glioblastoma", "OfficialTitle": "A Multi-center, Open-label, Randomized, Controlled Phase I Trial to Investigate the Effects of Cilengitide (EMD 121974) Using Dynamic MR and FET-PET Imaging as a Pharmacodynamic Measure of Response in Subjects With Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2012-08", "PrimaryCompletionDate": "2013-02", "Interventions": [ { "Name": "Drug (including placebo)", "Type": "DRUG", "Description": "Subjects will receive cilengitide monotherapy for 2 weeks (Weeks 1 and 2); thereafter, cilengitide will be given in combination with the standard treatment regimen during Weeks 3 to 36. The standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.\n\nCilengitide monotherapy treatment will be given to subjects in Group A for another 10 months as maintenance treatment (Weeks 37 to 78). Subjects in Group A may continue to receive cilengitide maintenance treatment beyond 10 months (beyond Week 78) until occurrence of progressive disease (PD) or unacceptable toxicity, or withdrawal for any other reason. A 28-day safety follow-up will be performed after the last dose of cilengitide.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Standard therapy", "Type": "OTHER", "Description": "In the first two weeks, treatment of subjects in Group B will be in line with the SoC. Thereafter the standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Merck KGaA, Darmstadt, Germany", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01205334", "BriefTitle": "Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Administration of CMV (Cytomegalovirus)-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme (COGLI)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-11", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "Autologous CMV-specific CTL", "Type": "BIOLOGICAL", "Description": "CMV-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line with a minimum 20g cannula. The expected volume will be 1-50 cc.\n\nAt the discretion of the attending physician, subjects can receive repeat infusions of modified T cells at the same dose level as long as they do not have progressive disease (up to a maximum of 6 doses and the minimum interval between repeat infusions is 6 weeks). Infusion procedures and follow-up will be identical to those for the first infusion. Patients, who receive additional doses of CTLs will be monitored exactly like after the 1st CTL infusion.", "OtherNames": [ "Cytomegalovirus-specific cytotoxic T-Lymphocytes" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Baylor College of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Center for Cell and Gene Therapy, Baylor College of Medicine", "The Methodist Hospital Research Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00613132", "BriefTitle": "Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG", "OfficialTitle": "Phase I Dose Escalation of Gleevec in Combination With RAD001 Plus Hydroxyurea for Patients With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-05", "PrimaryCompletionDate": "2008-08", "Interventions": [ { "Name": "Gleevec, RAD001, and Hydroxyurea", "Type": "DRUG", "Description": "Dose of Gleevec will be 400 mg in 1st cohort \\& will be increased to 600 mg po/day \\& then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 \\& hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.", "OtherNames": [ "Gleevec-Imatinib-Imatinib mesylate", "RAD001-Everolimus", "Hydroxyurea-Droxia-Hydrea-Hydroxycarbamide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01113398", "BriefTitle": "AMG 102 and Avastin for Recurrent Malignant Glioma", "OfficialTitle": "Phase II Study to Evaluate the Efficacy and Safety of AMG 102 and Avastin in Subjects With Recurrent Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2014-11", "Interventions": [ { "Name": "AMG 102", "Type": "DRUG", "Description": "AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.", "OtherNames": [ "rilotumumab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Avastin", "Type": "DRUG", "Description": "Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.", "OtherNames": [ "Bevacizumab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Katy Peters", "LeadSponsorClass": "OTHER", "Collaborators": [ "Amgen" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05463848", "BriefTitle": "Surgical Pembro +/- Olaparib w TMZ for rGBM", "OfficialTitle": "A Surgical \"Window-of-Opportunity\" and Phase II Trial of Pembrolizumab, Olaparib and Temozolomide in Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-10-21", "PrimaryCompletionDate": "2026-02-01", "Interventions": [ { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Intravenous infusion", "OtherNames": [ "MK3475" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "PD-1" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Olaparib", "Type": "DRUG", "Description": "Pill taken by mouth", "OtherNames": [ "MK-7339" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "PD-1" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Pill taken by mouth", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "PARP", "PD-1" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "L. Nicolas Gonzalez Castro, MD, PhD", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "PARP", "PD-1" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT03383978", "BriefTitle": "Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma", "OfficialTitle": "Multicenter, Open Label, Phase I Study of Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2017-12-01", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "NK-92/5.28.z", "Type": "BIOLOGICAL", "Description": "Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Ezabenlimab", "Type": "DRUG", "Description": "Intravenous infusion of Ezabenlimab 240mg q 3 weeks", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Johann Wolfgang Goethe University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "DRK Blutspendedienst Baden-Württemberg-Hessen gGmbH", "Georg-Speyer-Haus", "LOEWE Center Frankfurt Cancer Institute", "German Cancer Research Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04216329", "BriefTitle": "Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase I Clinical Trial of Selinexor (KPT-330) in Combination With Temozolomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2020-07-07", "PrimaryCompletionDate": "2023-09-29", "Interventions": [ { "Name": "Selinexor", "Type": "DRUG", "Description": "Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation.", "OtherNames": [ "Xpovio" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m\\^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care.", "OtherNames": [ "Temodar" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Generic Radiation therapy (RT)", "Type": "RADIATION", "Description": "Radiation therapy (RT) will be administered daily (Monday to Friday)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Selective serotonin receptor (5-HT3) antagonists", "Type": "OTHER", "Description": "Anti-emetic for breakthrough nausea.", "OtherNames": [ "Serotonin antagonists" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Olanzapine", "Type": "OTHER", "Description": "2.5mg to 5mg once a day if weight loss is rapid.", "OtherNames": [ "Zyprexa Relprevv", "Zyprexa Zydis", "Zyprexa" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Salt tablets", "Type": "DIETARY_SUPPLEMENT", "Description": "To treat hyponatremia, add salt tablets to participants diet per institutional guidelines.", "OtherNames": [ "Sodium Chloride tablets" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Anti-diarrheal", "Type": "OTHER", "Description": "Treat diarrhea with an anti-diarrheal per institutional guidelines", "OtherNames": [ "Loperamide", "Imodium" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02372409", "BriefTitle": "Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors", "OfficialTitle": "A Pilot Study of Using MRI-Guided Laser Heat Ablation to Induce Disruption of the Peritumoral Blood Brain Barrier to Enhance Delivery and Efficacy of Treatment of Pediatric Brain Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2015-08-14", "PrimaryCompletionDate": "2023-03-23", "Interventions": [ { "Name": "MRI-guided laser ablation", "Type": "DEVICE", "Description": null, "OtherNames": [ "MLA" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Doxorubicin", "Type": "DRUG", "Description": null, "OtherNames": [ "Adriamycin" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Etoposide", "Type": "DRUG", "Description": null, "OtherNames": [ "Etoposide phosphate", "VP-16", "Toposar", "Etopophos", "VePesid" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dynamic contrast-enhanced (DCE) MRI", "Type": "DEVICE", "Description": null, "OtherNames": [ "DCE-MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Dynamic susceptibility contrast (DSC) MRI", "Type": "DEVICE", "Description": null, "OtherNames": [ "DSC-MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00027612", "BriefTitle": "Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme", "OfficialTitle": "Pilot And Phase II Trial Of Irinotecan And Radiation Followed By Irinotecan And BCNU In Glioblastoma Multiforme Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2002-07", "PrimaryCompletionDate": "2006-10", "Interventions": [ { "Name": "carmustine", "Type": "DRUG", "Description": "IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "irinotecan hydrochloride", "Type": "DRUG", "Description": "IV", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00916409", "BriefTitle": "Effect of NovoTTF-100A Together With Temozolomide in Newly Diagnosed Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2016-12", "Interventions": [ { "Name": "NovoTTF-100A device", "Type": "DEVICE", "Description": "patients will be treated continuously with the NovoTTF-100A device, in addition to Temozolomide. NovoTTF-100A treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "maintenance Temozolomide will be administered according to the approved dosing scheme as follows: Maintenance Phase Cycle 1: Four weeks after completing the Temozolomide + Radiotherapy phase, Temozolomide is administered for an additional 6 cycles of maintenance treatment. Dosage in Cycle 1 (maintenance) is 150 mg/m2 once daily for 5 days followed by 23 days without treatment.\n\nCycles 2-6: At the start of Cycle 2, the dose is escalated to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs. If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NovoCure Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04741984", "BriefTitle": "Monocyte Antigen Carrier Cells for Newly Diagnosed GBM", "OfficialTitle": "The DEMAND Study: Dose Escalation Study of Monocyte Antigen Carrier Cells for Newly Diagnosed Glioblastoma With Unmethylated MGMT Gene Promoter", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2023-08", "PrimaryCompletionDate": "2025-05", "Interventions": [ { "Name": "MT-201-GBM monocyte vaccine", "Type": "BIOLOGICAL", "Description": "monocytes isolated from patient's leukapheresis loaded with CMV pp65-LAMP (Lysosomal-associated Membrane Protein) mRNA (Messenger Ribonucleic Acid)", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [] } } ], "LeadSponsorName": "Michael Gunn", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [] } }, { "NCTId": "NCT06193538", "BriefTitle": "The Safety and Effectiveness of NV-A01 in Glioma Patients", "OfficialTitle": "Clinical Study on the Safety and Effectiveness of NV-A01 in the Treatment of Advanced Glioma Patients", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2023-09-14", "PrimaryCompletionDate": "2024-12", "Interventions": [ { "Name": "Recombinant NV-A01 adenovirus injection", "Type": "DRUG", "Description": "Patients with advanced glioblastoma were intratumoral injected with NV-A01. Or the NV-A01 was injected after tumor resection.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "First Affiliated Hospital of Wannan Medical College", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01702792", "BriefTitle": "Derivation of Tumor Specific Hybridomas", "OfficialTitle": "Vaccination of Patients With Newly Diagnosed Glioblastoma Using Autologous Tumor Lysate and Montanide Emulsion for Derivation of Tumor Specific Hybridomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2014-01", "PrimaryCompletionDate": "2015-05-06", "Interventions": [ { "Name": "Tumor Vaccine", "Type": "BIOLOGICAL", "Description": "Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.", "OtherNames": [ "Autologous Tumor Lysate and Montanide Emulsion" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dartmouth-Hitchcock Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Vermont" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01062399", "BriefTitle": "Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Trial of Concurrent RAD001 (Everolimus) With Temozolomide/Radiation Followed by Adjuvant RAD001/Temozolomide in Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2016-06", "Interventions": [ { "Name": "concurrent RAD001 10 mg/day", "Type": "DRUG", "Description": "During radiation: RAD001 10 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.", "OtherNames": [ "everolimus" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "concurrent temozolomide", "Type": "DRUG", "Description": "During radiation: temozolomide 75 mg/m2/day orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42. Dose rounded to the nearest 5 mg.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Intensity Modulated RT (IMRT) allowed. For both IMRT and 3D conformal radiotherapy (3D-CRT) plans, one treatment of 2 Gy given daily 5 days per week for a total of 60 Gy over 6 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "concurrent RAD001 2.5 mg/day", "Type": "DRUG", "Description": "During radiation: RAD001 2.5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.", "OtherNames": [ "everolimus" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "concurrent RAD001 5 mg/day", "Type": "DRUG", "Description": "During radiation: RAD001 5 mg orally daily during radiation therapy; one hour prior to radiation and in the morning on weekends on days 1-42.", "OtherNames": [ "everolimus" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "post-radiation RAD001 10 mg/day", "Type": "DRUG", "Description": "Post-radiation: RAD001 10 mg orally daily on days 1-28 of each cycle, for up to 12 cycles, starting 28 days after the completion of radiation therapy (Cycle = 28 days).", "OtherNames": [ "everolimus" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "post-radiation temozolomide", "Type": "DRUG", "Description": "Post-radiation: temozolomide 150 mg/m2/day - 200 mg/m2/day orally daily on days 1-5 of each cycle, starting 28 days after the completion of radiation therapy for up to 12 cycles (Cycle = 28 days)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)", "NRG Oncology" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04874506", "BriefTitle": "MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)", "OfficialTitle": "An Open Label Study to Assess the Safety and Clinical Efficacy of MBM-02 to Increase Survival in Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2021-06-01", "PrimaryCompletionDate": "2023-01", "Interventions": [ { "Name": "MBM-02", "Type": "DRUG", "Description": "Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.", "OtherNames": [ "Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Matrix Biomed, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "MedStar Health" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT04135807", "BriefTitle": "Implantable Microdevice In Primary Brain Tumors", "OfficialTitle": "A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2020-03-03", "PrimaryCompletionDate": "2028-01-21", "Interventions": [ { "Name": "Microdevice", "Type": "COMBINATION_PRODUCT", "Description": "Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started.\n\nThe microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.", "OtherNames": [ "Implantable Microdevice" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Oliver Jonas", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00906516", "BriefTitle": "Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2009-05", "PrimaryCompletionDate": "2010-09", "Interventions": [ { "Name": "Neuradiab in combination with Bevacizumab (Avastin)", "Type": "DRUG", "Description": "Patients will be treated following surgical removal of recurrent glioblastoma with a single intracavitary dose of Neuradiab® delivering 44 Gy±10% to the ridge of the surgically created resection cavity followed by therapy with Bevacizumab (Avastin) at a minimum of 30 days after Neuradiab administration.\n\nTreatment with Bevacizumab will consist of 10mg/kg iv on days 1 and 15 every 28 days. Other chemotherapies (in addition to Avastin) will be permitted based on most current clinical practice and clinical evaluation of the patient.", "OtherNames": [ "131I-labeled anti-tenascin murine monoclonal antibody;", "Bevacizumab" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Bradmer Pharmaceuticals Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01317212", "BriefTitle": "Dose-Escalation Study of Carboplatin Administration Into the Brain for Glioblastoma Multiforme", "OfficialTitle": "A Phase I Trial of Carboplatin Administered by Convection-Enhanced Delivery to Patients With Recurrent/Progressive Glioblastoma Multiforme", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2015-05", "PrimaryCompletionDate": "2017-05", "Interventions": [ { "Name": "Peritumoural carboplatin administration.", "Type": "DRUG", "Description": "Peritumoural carboplatin administration by convection-enhanced delivery (CED) through 4 implanted intracranial catheters. Infusions conducted weekly for 4 consecutive weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "North Bristol NHS Trust", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03463265", "BriefTitle": "Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 2, Open-label Study of ABI-009 (Nab-Rapamycin) in Patients With Recurrent High-grade Glioma and Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2018-08-01", "PrimaryCompletionDate": "2022-08-26", "Interventions": [ { "Name": "nab-sirolimus", "Type": "DRUG", "Description": "nab-sirolimus, single agent", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "nab-sirolimus + temozolomide", "Type": "DRUG", "Description": "temozolomide, combination", "OtherNames": [ "nab-sirolimus", "temozolomide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "nab-sirolimus + bevacizumab", "Type": "DRUG", "Description": "bevacizumab, combination", "OtherNames": [ "nab-sirolimus", "bevacizumab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "nab-sirolimus + lomustine", "Type": "DRUG", "Description": "lomustine, combination", "OtherNames": [ "nab-sirolimus", "lomustine (CCNU)" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "nab-sirolimus + marizomib (MRZ)", "Type": "DRUG", "Description": "marizomib (MRZ), combination", "OtherNames": [ "nab-sirolimus", "marizomib (MRZ)" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "nab-sirolimus + temozolomide + radiotherapy", "Type": "DRUG", "Description": "temozolomide + radiotherapy, combination", "OtherNames": [ "nab-sirolimus", "temozolomide", "radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Aadi Bioscience, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF", "mTOR" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT03714334", "BriefTitle": "DNX-2440 Oncolytic Adenovirus for Recurrent Glioblastoma", "OfficialTitle": "Phase I Trial of DNX-2440 Oncolytic Adenovirus in Patients With Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2018-10-16", "PrimaryCompletionDate": "2023-04-05", "Interventions": [ { "Name": "DNX-2440 injection", "Type": "DRUG", "Description": "DNX-2440 virus will be injected stereotactically", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Clinica Universidad de Navarra, Universidad de Navarra", "LeadSponsorClass": "OTHER", "Collaborators": [ "DNAtrix, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06480721", "BriefTitle": "FET-PET-Guided Management of Pseudoprogression in Glioblastoma", "OfficialTitle": "FET-PET-Guided Management of Pseudoprogression in Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-08", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "Clinical management based on the index MRI and an additional [¹⁸F] FET PET scan", "Type": "OTHER", "Description": "Patients in the investigational arm will undergo the extra FET-PET scan, with use of the O-(2-\n\n¹⁸F-fluoroethyl)-L-tyrosine (¹⁸F-FET) tracer. FET-PET scanning will be performed according to the joint European Association of Nuclear Medicine (EANM)/European Association of Neuro-Oncology (EANO)/Response Assessment in Neuro-oncology (RANO) guidelines. In most patients, a static scan (20-40 minutes post-injection) will performed. If the logistics of the research site allow for a dynamic scan (0-60 minutes post-injection), this will be performed. Interpretation will be done by an experienced nuclear medicine physician from the local center according to current European guidelines. Central review will be performed by a panel of nuclear medicine physicians from the study team. Clinical management is based on the index MRI and this additional \\[¹⁸F\\] FET PET scan.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Veerle Ruijters", "LeadSponsorClass": "OTHER", "Collaborators": [ "ZonMw: The Netherlands Organisation for Health Research and Development", "Curium PET France" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03463733", "BriefTitle": "Hydroxy-urea and Temozolomide in Patients With a Recurrent Malignant Brain Tumor (Glioblastoma)", "OfficialTitle": "International Multicenter Phase I Trial of Hydroxyurea in Combination With Dose-Intense Temozolomide in Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1" ], "StartDate": "2018-03-02", "PrimaryCompletionDate": "2021-06-01", "Interventions": [ { "Name": "Hydroxyurea", "Type": "DRUG", "Description": "147-94-4/HYDROXYCARBAMIDE/HYDROXYCARBAMIDE/based on myeloproliferative disorders (MPD) record: SUB08076MIG", "OtherNames": [ "Hydroxycarbamide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "85622-93-1 /TEMOZOLOMIDE/TEMOZOLOMIDE/based on myeloproliferative disorders (MPD) record: SUB10889MIG", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.E. van Linde", "LeadSponsorClass": "OTHER", "Collaborators": [ "Massachusetts General Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06108206", "BriefTitle": "Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma", "OfficialTitle": "Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-01-30", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "Adaptive Radiotherapy", "Type": "OTHER", "Description": "Each patient will undergo a brain MRI at the following time points:\n\n1. Baseline- within 2 weeks prior to the start of chemo-RT,\n2. Week #1- on Fractions # 4 or 5\n3. Week #2- between Fractions # 6-10 (at least 5 days after the Week 1 MRI)\n4. Week #3- between Fractions # 11-15 (at least 5 days after the Week 2 MRI)\n5. Week #4- between Fractions # 16-20 gadolinium contrast (at least 5 days after the Week 3 MRI)\n6. Week #5- on Fractions # 24 or 25 (after the start of the Conedown)\n7. Week #6- +/- 3 days of Fraction #30 (end of RT)\n\nPatients receiving hypofractionated radiotherapy will undergo a brain MRI at the following time points:\n\n1. Baseline- within 2 weeks prior to the start of your standard of care chemotherapy radiation treatment (chemo-RT),\n2. Week #1 - on Fractions #4 or 5\n3. Week #2 - between Fractions #6-10 (at least 5 days after the Week 1 MRI)\n4. Week #3 - between Fractions #11-15 (at least 5 days after the Week 2 MRI)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Columbia University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Varian Medical Systems" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT06220552", "BriefTitle": "The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma", "OfficialTitle": "Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma: A Single-arm, Prospective Phase II Clinical Study", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-12-27", "PrimaryCompletionDate": "2027-12-30", "Interventions": [ { "Name": "Sintilimab", "Type": "DRUG", "Description": "Sintilimab 200mg D1, Q3W", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Low-dose Radiotherapy", "Type": "RADIATION", "Description": "Radiotherapy 1Gy/1F, D1/D2/D8/D15, Q3W", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Fifth Affiliated Hospital, Sun Yat-Sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05297734", "BriefTitle": "Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer", "OfficialTitle": "Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-06-24", "PrimaryCompletionDate": "2028-01-31", "Interventions": [ { "Name": "Receive technology-based supportive cancer care", "Type": "OTHER", "Description": "All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.", "OtherNames": [ "Technology-based SCC approach" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Receive redesigned team-based supportive cancer care", "Type": "BEHAVIORAL", "Description": "Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.", "OtherNames": [ "Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Patient-Centered Outcomes Research Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "HEALTH_SERVICES_RESEARCH", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04689087", "BriefTitle": "A Prospective, Open-label, Single-arm Clinical Study", "OfficialTitle": "A Prospective, Open-label, Single-arm Clinical Study Evaluating Tumor Treating Fields (TTFields) in Combination With Chemotherapy for Recurrent Glioblastom", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2020-04-01", "PrimaryCompletionDate": "2021-07-01", "Interventions": [ { "Name": "TTFields", "Type": "COMBINATION_PRODUCT", "Description": "For patients with relapsed GBM, before receiving electric field treatment, the patient can be re-operated, and TTFields+BPC chemotherapy is used after surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sun Yat-sen University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "PREVENTION", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04629209", "BriefTitle": "A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma", "OfficialTitle": "A Phase II, Open Label Study of ONC201 in Adults With EGFR-low Glioblastoma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2024-06-28", "PrimaryCompletionDate": "2024-12-31", "Interventions": [ { "Name": "ONC201", "Type": "DRUG", "Description": "ONC201 is a orally active, small molecule DRD2 antagonist that kills cancer cells but not normal cells.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Masonic Cancer Center, University of Minnesota", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of Minnesota" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT00686725", "BriefTitle": "Standard Temodal (Temozolomide) Regimen Versus Standard Regimen Plus Early Postsurgery Temodal for Newly Diagnosed Glioblastoma Multiforme (Study P05572)", "OfficialTitle": "A Clinical Study of Standard TEMODAL® Regimen Versus Standard Regimen Plus Early Post-Surgery TEMODAL® Chemotherapy in Treatment on Patients With Newly Diagnosed Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE4" ], "StartDate": "2008-06-24", "PrimaryCompletionDate": "2011-09-28", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [ "Temodal", "Temodar", "SCH 052365" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": null, "OtherNames": [ "Irradiation", "radiation therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00025558", "BriefTitle": "Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Brain Cancer", "OfficialTitle": "Dose Escalation of Temozolomide in Combination With Thiotepa and Carboplatin With Autologous Stem Cell Rescue in Patients With Malignant Brain Tumors With Minimal Residual Disease", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2000-10", "PrimaryCompletionDate": "2007-05", "Interventions": [ { "Name": "filgrastim", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "thiotepa", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02337426", "BriefTitle": "Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase I Trial of Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2015-02-13", "PrimaryCompletionDate": "2016-11-08", "Interventions": [ { "Name": "Dimethyl Fumarate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Fumaric Acid, Dimethyl Ester" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "Irradiated", "Irradiation", "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Virginia Commonwealth University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00303940", "BriefTitle": "Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors", "OfficialTitle": "A Phase I Trial and Pharmacokinetic Study of Talabostat (PT-100, Val-Boro-Pro) in Combination With Temozolomide or Carboplatin in Pediatric Patients With Relapsed or Refractory Solid Tumors Including Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-12", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "talabostat mesylate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "National Institutes of Health Clinical Center (CC)", "LeadSponsorClass": "NIH", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05879250", "BriefTitle": "WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Multi-Arm, Open Label, Phase II Trial of WP1066 and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-05-22", "PrimaryCompletionDate": "2027-12-27", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo collection of blood", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo routine radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Energy Type", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "STAT3 Inhibitor WP1066", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "WP 1066", "WP-1066", "WP1066" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Surgical Procedure", "Type": "PROCEDURE", "Description": "Undergo removal or biopsy of tumor", "OtherNames": [ "Operation", "Surgery", "Surgery Type", "Surgery, NOS", "Surgical", "Surgical Intervention", "Surgical Interventions", "Surgical Procedures", "Type of Surgery" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Moleculin Biotech, Inc.", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03291990", "BriefTitle": "5 Fraction Stereotactic Radiosurgery With Temozolomide for Glioblastoma Multiforme", "OfficialTitle": "A Pilot Study to Assess Feasibility of 5 Fraction Hypofractionated Stereotactic Radiosurgery Along With Standard Temozolomide as a Lymphocyte Sparing Therapy for Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2017-10-18", "PrimaryCompletionDate": "2020-08-19", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide", "OtherNames": [ "5 fraction radiosurgery with temozolomide" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02661282", "BriefTitle": "Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma", "OfficialTitle": "A Phase I/II Clinical Trial of Autologous CMV-Specific Cytotoxic T Cells for GBM Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-06-01", "PrimaryCompletionDate": "2022-02-23", "Interventions": [ { "Name": "Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytes", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "Autologous CMV-specific CTLs" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02871843", "BriefTitle": "RRx-001 + Radiation + Temozolomide In Newly Diagnosed Glioblastoma and Anaplastic Gliomas", "OfficialTitle": "G-FORCE-1: An Open-Label Phase 1 Two Part Dose Escalation Trial of RRx-001 Concurrent With Radiation and Temozolomide and RRx-001 + Temozolomide Post-RT In Newly Diagnosed Glioblastoma and Anaplastic Gliomas With Intact 1p/19q Chromosomes", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2017-02-14", "PrimaryCompletionDate": "2019-10-11", "Interventions": [ { "Name": "RRx-001 dose escalation with TMZ + RT", "Type": "DRUG", "Description": "Dose escalation of RRx-001. Dose levels of 0.5, 1.0, 2.0 and 4.0 mg, once weekly.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Conformal or intensity-modulated radiotherapy (60 Gy in 2 Gy fractions) given 5 days a week for 30 fractions (about 6 weeks)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Fixed dose Temozolomide (75 mg/m2)", "Type": "DRUG", "Description": "Oral temozolomide 75 mg/m2 daily for 6 weeks", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TMZ Maintenance", "Type": "DRUG", "Description": "TMZ maintenance at 150-200 mg/m2", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "EpicentRx, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00095940", "BriefTitle": "Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors", "OfficialTitle": "Molecular Biology and Phase II Study of Lapatinib (GW572016) in Pediatric Patients With Recurrent or Refractory Medulloblastoma, Malignant Glioma or Ependymoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2004-10", "PrimaryCompletionDate": "2010-07", "Interventions": [ { "Name": "lapatinib ditosylate", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "GSK572016", "GW-572016", "GW2016", "Lapatinib", "Tykerb" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "therapeutic conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "positron emission tomography", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "FDG-PET", "PET", "PET scan", "tomography, emission computed" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "MRI", "NMR imaging", "NMRI", "nuclear magnetic resonance imaging" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03275558", "BriefTitle": "Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma", "OfficialTitle": "Phase I Clinical Trial of Nasal Spray in Treating Patients With Recurrent Glioblastoma, Gliosarcoma, Glioma", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE1" ], "StartDate": "2018-07-17", "PrimaryCompletionDate": "2018-07-17", "Interventions": [ { "Name": "Axitinib 1 MG", "Type": "DRUG", "Description": "Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.\n\nSubjects take a nasal spray BID at a single dose in each nostril (approximately at the same time of day) for 7 weeks or unacceptable toxicity or other adverse events.", "OtherNames": [ "AG 013736, Inlyta" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Sunitinib 5 MG", "Type": "DRUG", "Description": "Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.", "OtherNames": [ "SU11248, Sutent" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Pazopanib 5 MG", "Type": "DRUG", "Description": "Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.", "OtherNames": [ "GW786034, Votrient" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Center Trials & Treatment", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00068510", "BriefTitle": "Vaccine Therapy in Treating Patients With Malignant Glioma", "OfficialTitle": "Phase I Dose Escalation Study of Autologous Tumor Lysate-Pulsed Dendritic Cell Immunotherapy for Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2003-06", "PrimaryCompletionDate": "2012-09", "Interventions": [ { "Name": "therapeutic autologous dendritic cells", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01180816", "BriefTitle": "Super-Selective Intraarterial Cerebral Infusion Of Temozolomide (Temodar) For Treatment Of Newly Diagnosed GBM And AA", "OfficialTitle": "Phase I Trial of Super-Selective Intraarterial Cerebral Infusion of Temozolomide (Temodar) for Treatment of Newly Diagnosed Glioblastoma Multiforme and Anaplastic Astrocytoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2010-08", "PrimaryCompletionDate": "2017-12", "Interventions": [ { "Name": "Super-Selective Intraarterial Intracranial Infusion of Temozolomide", "Type": "DRUG", "Description": "A single dose of Intraarterial Mannitol to open the blood brain barrier followed by Intra-arterial Temozolomide single dose (starting at 75mg/m2 and up to 250mg/m2)", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "Feinstein Institute for Medical Research", "Hofstra North Shore" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00541138", "BriefTitle": "Tamoxifen, Carboplatin, and Topotecan in Treating Patients With CNS Metastases or Recurrent Brain or Spinal Cord Tumors", "OfficialTitle": "A Pilot Study of Tamoxifen, Carboplatin and Topotecan in the Treatment of Recurrent or Refractory Primary Brain or Spinal Cord Tumors or Metastatic Epithelial Cancers With Central Nervous System Metastases", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-05", "PrimaryCompletionDate": "2007-10", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": "CBDCA AUC=3", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "tamoxifen citrate", "Type": "DRUG", "Description": "Tamoxifen 100mg bid", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "topotecan hydrochloride", "Type": "DRUG", "Description": "Topotecan 0.75 g/m2/d", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Start of tx, hours 24,28 and 72 during Topotecan infusion, and hours 1,2,4 and 6 after end of Topotecan infusion.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "City of Hope Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02986178", "BriefTitle": "Lerapolturev in Recurrent Malignant Glioma", "OfficialTitle": "A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (Lerapolturev) in Recurrent WHO Grade IV Malignant Glioma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-06-01", "PrimaryCompletionDate": "2022-09-30", "Interventions": [ { "Name": "lerapolturev", "Type": "BIOLOGICAL", "Description": "A single dose of lerapolturev, an oncolytic polio/rhinovirus recombinant", "OtherNames": [ "PVSRIPO" ], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "one cycle of oral lomustine", "OtherNames": [ "gleostine" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Istari Oncology, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Duke University" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05362409", "BriefTitle": "Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma", "OfficialTitle": "A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-06-29", "PrimaryCompletionDate": "2024-12-03", "Interventions": [ { "Name": "5 Aminolevulinic Acid", "Type": "DRUG", "Description": "5-aminolevulinic acid \\[5-ALA\\] administered orally 20 mg/kg every 4 weeks", "OtherNames": [ "5-ALA", "Gleolan" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "CV01-delivered ultrasound", "Type": "DEVICE", "Description": "CV01-delivered ultrasound every 4 weeks", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alpheus Medical, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04656535", "BriefTitle": "AB154 Combined With AB122 for Recurrent Glioblastoma", "OfficialTitle": "A Multi-Center Phase 0/I Trial of Anti-TIGIT Antibody AB154 in Combination With Anti-PD-1 Antibody AB122 for Recurrent Glioblastoma.", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2021-04-21", "PrimaryCompletionDate": "2026-07-30", "Interventions": [ { "Name": "Zimberelimab", "Type": "DRUG", "Description": "Zimberelimab (AB122) is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets PD-1.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Domvanalimab", "Type": "DRUG", "Description": "Domvanalimab (AB 154) is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TIGIT.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "Placebo", "Type": "DRUG", "Description": "Saline placebo comparator for pre-surgery treatment in cohort B4", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Yale University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Arcus Biosciences, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT06388733", "BriefTitle": "A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma", "OfficialTitle": "A Phase 3, Open-label, Randomized 2-arm Study Comparing the Clinical Efficacy and Safety of Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-06-19", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "Niraparib", "Type": "DRUG", "Description": "Participants will receive niraparib 200 mg orally once daily starting on Day 1 of RT. Following completion of RT, participants will continue niraparib adjuvant therapy orally once daily on Days 1 to 28 of each 28-day cycle until progression by BICR", "OtherNames": [ "Zejula" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Participants randomized to the comparator arm (Arm B) will receive SOC TMZ 75 mg/m2 orally once daily with RT starting on Day 1 of RT. Following completion of RT, participants will complete a 4-week rest period, and then receive adjuvant TMZ 150 to 200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle until progression by BICR or for a maximum of 6 cycles.", "OtherNames": [ "Temodar", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } } ], "LeadSponsorName": "Ivy Brain Tumor Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "GlaxoSmithKline" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PARP" ], "classes": [ "Alkylating agent", "DNA repair inhibitor" ] } }, { "NCTId": "NCT01920191", "BriefTitle": "Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma", "OfficialTitle": "Phase I/II Study of Intradermal IMA950 Peptide-based Vaccine Adjuvanted With Intra Muscular Poly-ICLC in Combination With Temozolomide in Newly Diagnosed HLA-A2 Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2013-08", "PrimaryCompletionDate": "2016-03", "Interventions": [ { "Name": "IMA 950", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Poly ICLC", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [ "Hiltonol" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Immunomonitoring", "Type": "OTHER", "Description": "Blood samples, DTH analysis", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University Hospital, Geneva", "LeadSponsorClass": "OTHER", "Collaborators": [ "Immatics Biotechnologies GmbH", "Oncovir, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00154375", "BriefTitle": "Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma", "OfficialTitle": "Phase III Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2004-10", "PrimaryCompletionDate": "2008-08", "Interventions": [ { "Name": "Imatinib mesylate", "Type": "DRUG", "Description": "Imatinib was supplied as 100 mg and 400 mg tablets packaged in polyethylene bottles.", "OtherNames": [ "Glivec®" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Hydroxyurea", "Type": "DRUG", "Description": null, "OtherNames": [ "Litalir®" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT00481455", "BriefTitle": "Phase 2 Study of Panzem Nanocrystal Colloidal Dispersion (NCD) in Combination With Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme (GBM)", "OfficialTitle": "A Single-Center, Open-Label, Phase II, Safety and Efficacy Study of Panzem Nanocrystal Colloidal Dispersion Administered Orally in Combination With Protracted Oral Fixed-Dose Temozolomide to Patients With Recurrent Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-04", "PrimaryCompletionDate": "2007-09", "Interventions": [ { "Name": "Panzem NCD", "Type": "DRUG", "Description": "2000 mg q8h, continuous dosing in 28 day cycles", "OtherNames": [ "2-methoxyestradiol", "2ME2" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Fixed dose", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "CASI Pharmaceuticals, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06831526", "BriefTitle": "Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Window-of-opportunity Early Phase I Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-11-06", "PrimaryCompletionDate": "2029-02-28", "Interventions": [ { "Name": "Azeliragon", "Type": "DRUG", "Description": "Provided by Cantex Pharmaceuticals", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Standard of care.", "OtherNames": [ "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation therapy", "Type": "RADIATION", "Description": "Standard of care.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Surgery or LITT", "Type": "PROCEDURE", "Description": "Standard of care surgical resection or laser interstitial thermal therapy (LITT).", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Washington University School of Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "Cantex Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05423210", "BriefTitle": "Atezolizumab and Pre-Surgical Brain Radiation Therapy for Glioblastoma Multiforme", "OfficialTitle": "A Pilot Study to Evaluate the Immunogenic Effects of Window-of-Opportunity Fractionated Stereotactic Radiotherapy Combined With Atezolizumab for Patients With Newly Diagnosed WHO CNS Grade 4 Glioma (Glioblastoma Multiforme)", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2022-10-25", "PrimaryCompletionDate": "2027-08", "Interventions": [ { "Name": "Atezolizumab + FSRT radiation", "Type": "COMBINATION_PRODUCT", "Description": "Atezolizumab 840mg IV every 2 weeks Fractionated Stereotactic Radiotherapy", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "Stony Brook University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-L1" ], "classes": [] } }, { "NCTId": "NCT05284643", "BriefTitle": "Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma", "OfficialTitle": "Pilot Trial of Spectroscopic MRI-guided, Dose-Escalated Proton Radiation Therapy and Bevacizumab for Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2022-09-30", "PrimaryCompletionDate": "2027-09-30", "Interventions": [ { "Name": "Intensity Modulated Proton Therapy (IMPT)", "Type": "RADIATION", "Description": "Participants will receive radiation therapy delivered via intensity modulated proton therapy (IMPT) simultaneous integrated boost technique over a period of 10 days, 5 days per week for approximately 2 weeks.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab will be administered intravenously (IV), beginning at a dose of 10 mg/kg every 2-3 weeks until disease progression.", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "University of Miami", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT00323076", "BriefTitle": "[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours", "OfficialTitle": "A Phase I/II Imaging Study of 1-a-D-(5-deoxy-5-[18]F-fluoroarabinofuranosyl)-2-nitroimidazole ([18]F-FAZA) in Patients With Known Squamous Cell Carcinoma of the Head & Neck, Small Cell and Non-Small Cell Carcinoma of the Lung, Lymphoma, Glioblastoma Multiforme, Neuroendocrine Tumours or Renal Cell Carcinoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2006-09-12", "PrimaryCompletionDate": "2019-02-04", "Interventions": [ { "Name": "18F-FAZA PET Imaging", "Type": "DRUG", "Description": "Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient.\n\nPhase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06047379", "BriefTitle": "Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis", "OfficialTitle": "An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients With Select Solid Tumors.", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-11-01", "PrimaryCompletionDate": "2027-02-28", "Interventions": [ { "Name": "NEO212 Oral Capsule", "Type": "DRUG", "Description": "NEO212 is a novel chemical entity that was generated by covalent conjugation of temozolomide (TMZ) with perillyl alcohol (POH).", "OtherNames": [ "POH-TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Ipilimumab", "Type": "DRUG", "Description": "Ipilimumab, sold under the brand name Yervoy, is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system. Cytotoxic T lymphocytes can recognize and destroy cancer cells.", "OtherNames": [ "Yervoy" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "CTLA-4", "IDH", "MET" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is given by slow injection into a vein.", "OtherNames": [ "Keytruda" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "IDH", "MET", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer.", "OtherNames": [ "Opdivo" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "IDH", "MET", "PD-1" ], "classes": [] } }, { "Name": "Regorafenib", "Type": "DRUG", "Description": "Regorafenib, sold under the brand name Stivarga among others, is an oral multi-kinase inhibitor developed by Bayer which targets angiogenic, stromal and oncogenic receptor tyrosine kinase. Regorafenib shows anti-angiogenic activity due to its dual targeted VEGFR2-TIE2 tyrosine kinase inhibition", "OtherNames": [ "Stivagra" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "EGFR", "IDH", "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It is used by injection into a vein.", "OtherNames": [ "Paraplatin" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [] } }, { "Name": "Paclitaxel", "Type": "DRUG", "Description": "Paclitaxel, sold under the brand name Taxol among others, is a chemotherapy medication used to treat ovarian cancer, esophageal cancer, breast cancer, lung cancer, Kaposi's sarcoma, cervical cancer, and pancreatic cancer. It is administered by intravenous injection", "OtherNames": [ "Taxol" ], "modality": [ "Other" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [] } }, { "Name": "FOLFIRI Protocol", "Type": "DRUG", "Description": "FOLFIRI is a chemotherapy regimen for treatment of colorectal cancer. It is made up of the following drugs:\n\nFOL - folinic acid (leucovorin), a vitamin B derivative with multiple applications, which in this context increases the cytotoxicity of 5-fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops synthesis; and IRI - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.", "OtherNames": [ "Zaltrap" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH", "MET" ], "classes": [] } }, { "Name": "Bevacizumab", "Type": "DRUG", "Description": "Bevacizumab, sold under the brand name Avastin among others, is a medication used to treat a number of types of cancers and a specific eye disease. For cancer, it is given by slow injection into a vein and used for colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma", "OtherNames": [ "Avastin", "Mvasi", "Zirabev", "Alymsys", "Vegzelma" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "IDH", "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Neonc Technologies, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Other", "Small Molecule" ], "trial_moa": { "targets": [ "CTLA-4", "EGFR", "IDH", "MET", "PD-1", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT00005796", "BriefTitle": "Combination Chemotherapy Plus Gene Therapy in Treating Patients With CNS Tumors", "OfficialTitle": "A Pilot Study of Dose-Intensified Procarbazine, CCNU, Vincristine (PCV) for Poor Prognosis Pediatric and Adult Brain Tumors Utilizing Fibronectin-Assisted, Retroviral-Mediated Modification of CD34+ Peripheral Blood Cells With O6-Methylguanine DNA Methyltransferase", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2000-02", "PrimaryCompletionDate": "2003-06", "Interventions": [ { "Name": "filgrastim", "Type": "PROCEDURE", "Description": "GCSF is given after chemo administration", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "gene therapy", "Type": "BIOLOGICAL", "Description": "stem cells are collected and given back to the patients after chemotherapy adminstration", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "lomustine", "Type": "DRUG", "Description": "chemotherapy is administered every 21 days", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "procarbazine hydrochloride", "Type": "DRUG", "Description": "chemotherapy is administered every 21 days.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "vincristine sulfate", "Type": "DRUG", "Description": "chemotherapy is administered every 21 days", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "in vitro-treated peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": "stem cells are reinfused after chemotherapy administration", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Indiana University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Indiana University Melvin and Bren Simon Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00376818", "BriefTitle": "Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers", "OfficialTitle": "Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2006-06", "PrimaryCompletionDate": "2008-04", "Interventions": [ { "Name": "exercise intervention", "Type": "BEHAVIORAL", "Description": "All participants will convene once per week for 8 weeks for a 90-minute session that will be based on yoga principles for a stress reduction.", "OtherNames": [ "Yoga" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "educational intervention", "Type": "OTHER", "Description": "A 15-minute educational session on a particular topic (mind-body connection; fight or flight response; relaxation response; the science and philosophy of yoga; the science of meditation; sleeping well; mindfulness; the healer within - how to harness your innate healing potential).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "physiologic testing", "Type": "OTHER", "Description": "Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.", "OtherNames": [ "questionnaire" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "management of therapy complications", "Type": "OTHER", "Description": "Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.", "OtherNames": [ "questionnaire" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "mind-body intervention procedure", "Type": "BEHAVIORAL", "Description": "Meditation practice in this study will consist of 15 minutes of \"body scan\" to completely relax the body from head to toe and will be followed by 15 minute silence during which the study participants will maintain awareness of their breath, bodily sensations and thoughts as they spontaneously arise. The remainder of the class will be devoted to a group discussion of personal reflections and challenges.", "OtherNames": [ "Meditation" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Measurement of stress-related hormones", "Type": "PROCEDURE", "Description": "Measurements of stress-related hormones: Stress hormones cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin will be measured in saliva because their levels in saliva accurately reflect blood levels (Carlson et al, 2004). The non-invasive saliva collection method by cotton swabs (Salivette® by Sardstedt Inc.) will be used in this study.", "OtherNames": [ "salivary samples" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00002824", "BriefTitle": "Gene Therapy in Treating Patients With Primary Brain Tumors", "OfficialTitle": "A PHASE I TRIAL OF HSV-TK ADENOVIRUS GENE THERAPY FOR PRIMARY BRAIN TUMORS", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1996-02", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "gene therapy", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "chemotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "ganciclovir", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05053880", "BriefTitle": "A Study to Evaluate Safety and Efficacy of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 1b/2a Study of ACT001 and Anti-PD-1 in Patients With Surgically Accessible Recurrent Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-09-22", "PrimaryCompletionDate": "2022-11", "Interventions": [ { "Name": "ACT001", "Type": "DRUG", "Description": "Phase1b - Starting approximately 2 weeks prior to the scheduled surgery, patient will receive an assigned dose of ACT001 by mouth in combination with a single dose of 200 mg pembrolizumab via an intravenous (IV-through a tube in vain) infusion in the clinic. Then patient will self administer ACT001 capsules twice daily by mouth, at the dose to which patient is assigned, until the evening prior to scheduled surgery. Patient will then undergo surgery to remove all or part of tumor. This a standard 3+3 dose escalation.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "Name": "ACT001 + Pembrolizumab", "Type": "DRUG", "Description": "Phase 2a - Starting approximately 2 weeks prior to the scheduled surgery, patient will receive a single dose of 200 mg pembrolizumab via an intravenous (IV) infusion in the clinic (an IV infusion means the drug will be delivered through a tube in your vein). Patient will then self-administer ACT001 capsules twice daily by mouth, at the dose to which patient is assigned, until the evening prior to scheduled surgery. Patient then will undergo surgery to remove all or part of tumor.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Accendatech USA Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "C3 Research Associates", "Avance Clinical Pty Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00058097", "BriefTitle": "Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of R115777 for the Treatment of Adults With Newly Diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-08", "PrimaryCompletionDate": "2007-01", "Interventions": [ { "Name": "tipifarnib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "R115777", "Zarnestra" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07347210", "BriefTitle": "Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma", "OfficialTitle": "Evaluation of UCPVax Vaccine +/- Pembrolizumab Combined With Standard Treatment as Adjuvant Therapy in Patients With Unmethylated MGMT Glioblastoma: a Randomized Phase II Trial", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2026-01", "PrimaryCompletionDate": "2029-01", "Interventions": [ { "Name": "UCPVax", "Type": "DRUG", "Description": "Priming : UCPVax (two helper peptides UCP2 and UCP4 + Montanide ISA51) at 0.5 mg subcutaneously at day 1, 8, 15, 29, 36 and 43\n\nBoost : UCPVax at 0.5 mg subcutaneously one month after priming and then every 8 weeks for 12 months maximum", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [] } }, { "Name": "Pembrolizumab", "Type": "DRUG", "Description": "400 mg/m1 every 6 weeks since day 1 until disease progression or unacceptable toxicity for a maximum of 1 year", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "150-200 mg/m2/day x 5 days per month x 6 months according to best standard of care starting at day 1 of week 1 (with vaccine 1 of UCPVax).\n\nAdditional treatment with NOVO-TTF200A will be allowed.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Centre Hospitalier Universitaire de Besancon", "LeadSponsorClass": "OTHER", "Collaborators": [ "Merck Sharp & Dohme LLC" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "PD-1" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03477110", "BriefTitle": "Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma", "OfficialTitle": "SPARE-Scalp Preservation and Radiation Plus Alternating Electric Tumor Treatment Field (NovoTTF, Optune) for Patients With Glioblastoma: A Pilot Study", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2018-05-04", "PrimaryCompletionDate": "2021-04-21", "Interventions": [ { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "362856", "Temcad", "Temodal", "Methazolastone", "Temodar" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "Irradiate", "RT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "NovoTTF-200A Device", "Type": "DEVICE", "Description": "Undergo tumor treatment fields therapy using NovoTTF-200A device", "OtherNames": [ "Optune" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Tumor Treating Fields Therapy", "Type": "PROCEDURE", "Description": "Undergo tumor treatment fields therapy using NovoTTF-200A device", "OtherNames": [ "Alternating Electric Field Therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sidney Kimmel Cancer Center at Thomas Jefferson University", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00179803", "BriefTitle": "Stem Cell Transplant for High Risk Central Nervous System (CNS) Tumors", "OfficialTitle": "Phase II Prospective Study of Sequential Myeloablative Chemotherapy With Stem Cell Rescue for the Treatment of Selected High Risk CNS Tumors and Recurrent CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1998-03", "PrimaryCompletionDate": "2008-01", "Interventions": [ { "Name": "Stem Cell Transplant", "Type": "PROCEDURE", "Description": "Group A: recurrent medulloblastoma, recurrent germ cell tumor\n\n* Cytoxan treatment\n* Stem cell autologous harvest\n\nGroup B: GBM, high grade astrocytoma, rhabdoid tumors, pineoblastoma, or supratentorial PNET\n\n* Carboplatin and Etoposide treatment\n* Autologous stem cell harvest\n\nThe preparatory regimen used for Stem Cell Rescue #1 will be Carboplatinum, VP-16 and Thiotepa. If the patient has recuperated his ANC to \\>1,000 within 50 days after Stem Cell Rescue #1, (sustained without G-CSF support) a neuroradiographic evaluation will be performed. If there is lack of progression, the patient will then proceed to Stem Cell Rescue # 2 with Cyclophosphamide and Melphalan, followed by stem cell rescue.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ann & Robert H Lurie Children's Hospital of Chicago", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01383135", "BriefTitle": "Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2", "OfficialTitle": "Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2010-10", "PrimaryCompletionDate": "2012-04", "Interventions": [ { "Name": "F18-FPPRGD2", "Type": "DRUG", "Description": "Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Stanford University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00961090", "BriefTitle": "Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery", "OfficialTitle": "A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2015-04-22", "Interventions": [ { "Name": "Aminolevulinic Acid", "Type": "DRUG", "Description": "20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery", "OtherNames": [ "ALA" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Matthew R Quigley", "LeadSponsorClass": "OTHER", "Collaborators": [ "DUSA Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00998010", "BriefTitle": "Bortezomib, Temozolomide, and Regional Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "Phase II Trial of Velcade (Bortezomib) in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-10-03", "PrimaryCompletionDate": "2016-03-29", "Interventions": [ { "Name": "bortezomib + temozolomide+ radiation therapy", "Type": "DRUG", "Description": "Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "Millennium Pharmaceuticals, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06824662", "BriefTitle": "Phase 0 With Expansion Phase Clinical Trial of Quisinostat Plus Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-Wildtype Glioblastomas", "OfficialTitle": "A Phase 0/1b 'Trigger' Clinical Trial With an Expansion Phase of Quisinostat Plus Fractionated Radiotherapy in Newly-diagnosed and Recurrent Grade 4 IDH-WT Glioblastomas", "OverallStatus": "RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2025-09-04", "PrimaryCompletionDate": "2027-07-01", "Interventions": [ { "Name": "Quisinostat", "Type": "DRUG", "Description": "a highly potent and orally active HDAC inhibitor", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "IDH" ], "classes": [ "Epigenetic modifier" ] } } ], "LeadSponsorName": "Nader Sanai", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "IDH" ], "classes": [ "Epigenetic modifier" ] } }, { "NCTId": "NCT05513859", "BriefTitle": "Investigational Imaging Technique During Brain Surgery", "OfficialTitle": "Towards In-Vivo, Intraoperative Image Guided Brain Tumor Margin Assessment With Quantitative Oblique Back Illumination Microscopy", "OverallStatus": "SUSPENDED", "Phase": [ "NA" ], "StartDate": "2024-03-11", "PrimaryCompletionDate": "2026-06-28", "Interventions": [ { "Name": "Craniotomy", "Type": "PROCEDURE", "Description": "Undergo craniotomy", "OtherNames": [ "Open Craniotomy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quantitative Oblique Back-Illumination Microscopy", "Type": "DEVICE", "Description": "Undergo intraoperative microscopy utilizing qOBM", "OtherNames": [ "qOBM" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02546102", "BriefTitle": "Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma", "OfficialTitle": "A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE3" ], "StartDate": "2024-12", "PrimaryCompletionDate": "2025-12", "Interventions": [ { "Name": "ICT-107", "Type": "BIOLOGICAL", "Description": "Autologous dendritic cells pulsed with peptides associated with tumor antigens", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Placebo", "Type": "BIOLOGICAL", "Description": "Control, autologous monocytes-enriched PBMC.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Precision Life Sciences Group", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Medelis Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05353530", "BriefTitle": "IL-8 Receptor-modified CD70 CAR T Cell Therapy in CD70+ Adult Glioblastoma", "OfficialTitle": "Phase I Study -To Assess Safety and Feasibility of IL-8 Receptor Modified Patient-derived Activated CD70 CAR T Cell Therapy in CD70+ Adult GBM and Pediatric High-Grade Gliomas (pHGG)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-07-25", "PrimaryCompletionDate": "2027-12", "Interventions": [ { "Name": "Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells", "Type": "BIOLOGICAL", "Description": "Single dose of 8R-70CAR T cells administered IV", "OtherNames": [ "8R-70CAR T cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "AM Rosen Foundation" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04782609", "BriefTitle": "Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1b Dose Escalation/Dose Expansion Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2021-12-27", "PrimaryCompletionDate": "2022-11-04", "Interventions": [ { "Name": "Icapamespib", "Type": "DRUG", "Description": "to test the safety, tolerability and pharmacokinetics of single agent oral icapamespib in patients with recurrent brain lesions.", "OtherNames": [ "Malignant Glioma" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Samus Therapeutics, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01986348", "BriefTitle": "Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas", "OfficialTitle": "A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients With Recurrent Gliomas", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2014-03-03", "PrimaryCompletionDate": "2020-01-23", "Interventions": [ { "Name": "Selinexor", "Type": "DRUG", "Description": "One cycle is 28 days (4 weeks).", "OtherNames": [ "KPT-330" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Karyopharm Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01044225", "BriefTitle": "Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma", "OfficialTitle": "CeCil: A Randomized, Non-comparative Clinical Trial of the Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2009-09", "PrimaryCompletionDate": "2011-09", "Interventions": [ { "Name": "Cetuximab", "Type": "DRUG", "Description": "An initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Cilengitide EMD 121974", "Type": "DRUG", "Description": "A dose of 2000 mg by IV administration 2 weekly.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Bart Neyns", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00797940", "BriefTitle": "Convection Enhanced Localized Administration of PRX321 With Real-time Imaging for Therapy of Recurrent Glioblastoma (CLARITY-1)", "OfficialTitle": "Phase II, Multi-center, Open-Label, Single-Arm Study of Intratumoral Infusion of PRX321 in Subjects With Glioblastoma Multiforme at First Recurrence or Progression", "OverallStatus": "WITHDRAWN", "Phase": [ "PHASE2" ], "StartDate": "2009-01", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "IL-4PE", "Type": "DRUG", "Description": "Subjects will receive intratumoral infusion of PRX321 administered via convection-enhanced delivery (CED) at a concentration of 1.5 μg/mL and a total volume of 60 mL over 2 to 7 days.", "OtherNames": [ "PRX321" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sophiris Bio Corp", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00064363", "BriefTitle": "Talampanel in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "A Phase II Trial Of Talampanel In Patients With Recurrent High-Grade Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2003-06", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "talampanel", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Institutes of Health Clinical Center (CC)", "LeadSponsorClass": "NIH", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05565521", "BriefTitle": "UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly", "OfficialTitle": "UNITy-BasED MR-Linac Adaptive Simultaneous Integrated Hypofractionated Boost Trial for High Grade Glioma in the Elderly", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2022-12-13", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Dose escalation + Reduced Margin Adaptive Radiotherapy", "Type": "RADIATION", "Description": "Concurrent chemoradiation with temozolomide (TMZ) over 3 weeks (40 Gy in 15 fractions). The gross tumor volume (GTV) plus margin will be boosted simultaneously (SIB) to 52.5 Gy in 15 fractions. Radiation will be delivered on the MR-Linac with a reduced clinical target volume (CTV) margin of minimum 5 mm and a weekly online adaptive approach.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sunnybrook Health Sciences Centre", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00660543", "BriefTitle": "MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy", "OfficialTitle": "Early Assessment of Tumor Response to Therapy Using Ferumoxytol (Code 7228) as an MR Contrast Agent in Patients With Glioblastoma Multiforme (MedDRA Code 10018337)", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2006-12", "PrimaryCompletionDate": "2014-06", "Interventions": [ { "Name": "Gadolinium", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Gd" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Ferumoxytol Non-Stoichiometric Magnetite", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Fe3O4", "Feraheme", "Ferumoxytol" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Dynamic Contrast-Enhanced Magnetic Resonance Imaging", "Type": "OTHER", "Description": "Undergo DCE MRI", "OtherNames": [ "DCE MRI", "DCE-MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging", "Type": "OTHER", "Description": "Undergo DSC MRI", "OtherNames": [ "DSC-MRI", "Dynamic Susceptibility Contrast-Enhanced MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Diffusion Weighted Imaging", "Type": "OTHER", "Description": "Undergo DWI", "OtherNames": [ "Diffusion Weighted MRI", "DWI", "DWI MRI", "DWI-MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "MRI-Based Angiogram", "Type": "OTHER", "Description": "Undergo TOF MR angiography", "OtherNames": [ "Magnetic Resonance Angiogram", "MRA" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "OHSU Knight Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02968940", "BriefTitle": "Avelumab With Hypofractionated Radiation Therapy in Adults With Isocitrate Dehydrogenase (IDH) Mutant Glioblastoma", "OfficialTitle": "A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-03-17", "PrimaryCompletionDate": "2019-08-29", "Interventions": [ { "Name": "Avelumab", "Type": "BIOLOGICAL", "Description": "Avelumab 10 mg/kg intravenously (IV) every 2 weeks", "OtherNames": [ "MSB0010718C" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH", "PD-L1" ], "classes": [] } }, { "Name": "Hypofractionated radiation therapy (HFRT)", "Type": "RADIATION", "Description": "Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "IDH", "PD-L1" ], "classes": [] } } ], "LeadSponsorName": "NYU Langone Health", "LeadSponsorClass": "OTHER", "Collaborators": [ "EMD Serono" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "IDH", "PD-L1" ], "classes": [] } }, { "NCTId": "NCT01631552", "BriefTitle": "Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer", "OfficialTitle": "A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2012-12-17", "PrimaryCompletionDate": "2019-03-01", "Interventions": [ { "Name": "Sacituzumab Govitecan-hziy (SG)", "Type": "DRUG", "Description": "Administered via intravenous (IV) infusion", "OtherNames": [ "hRS7-SN38", "IMMU-132" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Gilead Sciences", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03990285", "BriefTitle": "[18F]Fluciclovine in Post-treatment Glioblastoma ( Axumin )", "OfficialTitle": "Multimodality 18F-Fluciclovine PET, MRI and Cell Free Circulating DNA to Differentiate Tumor Progression From Pseudoprogression in Patients With Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2019-06-12", "PrimaryCompletionDate": "2021-11-18", "Interventions": [ { "Name": "Axumin, Intravenous Solution", "Type": "DRUG", "Description": "To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ali Nabavizadeh", "LeadSponsorClass": "OTHER", "Collaborators": [ "Blue Earth Diagnostics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03347097", "BriefTitle": "Adoptive Cell Therapy of Autologous TIL and PD1-TIL Cells for Patients With Glioblastoma Multiforme", "OfficialTitle": "The Safety and Efficacy Study of Autologous Tumor-infiltrating T Lymphocyte（TIL）and Transgenic Modified TIL Cells Adoptive Therapies for Patients With Glioblastoma Multiforme", "OverallStatus": "UNKNOWN", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2017-01-01", "PrimaryCompletionDate": "2020-01-01", "Interventions": [ { "Name": "TIL", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "PD1-TIL", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Huashan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Shanghai Cell Therapy Research Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT05439278", "BriefTitle": "Conventional Versus Hypofractionated Radiotherapy With Temozolomide in Elderly Glioblastoma", "OfficialTitle": "Randomized Phase III Study of Conventional Versus Hypofractionated Radiotherapy Combined With Temozolomide in Elderly Glioblastoma Patients", "OverallStatus": "RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2025-02-01", "PrimaryCompletionDate": "2028-12-31", "Interventions": [ { "Name": "Hypofractionated radiotherapy", "Type": "RADIATION", "Description": "40.05 Gy in 15 fractions (daily treatment, 5 per week)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Conventional radiotherapy", "Type": "RADIATION", "Description": "60 Gy in 30 fractions (daily treatment, 5 per week)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "concurrent (75 mg/m2/day qd) and adjuvant (6 cycles)", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Severance Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00005976", "BriefTitle": "Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma", "OfficialTitle": "Phase I/II Trial of Pyrazoloacridine and Carboplatin in Patients With Recurrent Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-05", "PrimaryCompletionDate": "2006-12", "Interventions": [ { "Name": "carboplatin", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pyrazoloacridine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04829097", "BriefTitle": "Neoadjuvant Temozolomide Combined With Simultaneous IMRT for Treatment of Glioblastoma", "OfficialTitle": "A Prospective Multicenter Randomized Controlled Clinical Trial of Neoadjuvant Temozolomide Combined With Simultaneous Increased Intensity-modulated Radiotherapy in the Treatment of Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE3" ], "StartDate": "2020-11-01", "PrimaryCompletionDate": "2023-11-01", "Interventions": [ { "Name": "Temozolomide", "Type": "COMBINATION_PRODUCT", "Description": "The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.", "OtherNames": [ "Intensity-Modulated Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00005082", "BriefTitle": "Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma", "OfficialTitle": "Magnetic Resonance Correlates of Glioma Tumor Burden", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "1998-11", "PrimaryCompletionDate": "2000-11", "Interventions": [ { "Name": "biopsy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "magnetic resonance imaging", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Jonsson Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006916", "BriefTitle": "Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2001-06", "PrimaryCompletionDate": "2005-12", "Interventions": [ { "Name": "bleomycin", "Type": "BIOLOGICAL", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Ommaya reservoir", "Type": "DEVICE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": "60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01939574", "BriefTitle": "A Explore Study of Bevacizumab Combined With Conventional Therapy in Glioblastoma", "OfficialTitle": "An Open-label, Single Arm Study to Explore Whether Potential Image Biomarkers Correlate With Efficacy of Bevacizumab Combined With Conventional Therapy in Newly Diagnosed Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2013-08", "PrimaryCompletionDate": "2016-06", "Interventions": [ { "Name": "Chemoradiation Therapy", "Type": "OTHER", "Description": "* Radiation therapy:For both intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiation therapy (3D-CRT) plans, one treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks.\n* Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days.\n* Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle,at the beginning of the 4th week of radiation. The dose will be 10 mg/kg of actual body weight.", "OtherNames": [ "Radiation therapy", "Temozolomide", "Bevacizumab" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Adjuvant Therapy", "Type": "OTHER", "Description": "* Temozolomide will be administered orally once per day for 5 consecutive days (days 1-5) of a 28-day cycle. The starting dose for the first cycle will be 150 mg/m2/day, with a single dose escalation to 200 mg/m2/day in subsequent cycles if no treatment-related adverse events\\> grade 2 are noted.\n* Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle. The dose will be 10 mg/kg of actual body weight.", "OtherNames": [ "Temozolomide", "Bevacizumab" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Shandong Cancer Hospital and Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06896110", "BriefTitle": "Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma", "OfficialTitle": "Phase 1 Trial of Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma", "OverallStatus": "ENROLLING_BY_INVITATION", "Phase": [ "PHASE1" ], "StartDate": "2025-06-05", "PrimaryCompletionDate": "2027-03", "Interventions": [ { "Name": "Nivolumab", "Type": "DRUG", "Description": "Intrathecal nivolumab will be given at a flat dose of 40 mg", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Azacitidine (AZA)", "Type": "DRUG", "Description": "Intrathecal azacitidine will be dose-escalated with 4 dose levels (5, 10, 20, 40 mg) using a 3+3 design.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "lumbar puncture", "Type": "PROCEDURE", "Description": "Lumbar puncture for intrathecal delivery and collection of CSF", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "MRI Contrast", "Type": "DIAGNOSTIC_TEST", "Description": "MRI Brain and full Spine (with and without contrast) will be performed prior to enrollment. During trial therapy, MRI Brain (with and without contrast) will be performed after cycle 1 and after that every 8 weeks (e.g. after cycle 3, cycle 5, etc…)", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Andrew P. Groves", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT03861598", "BriefTitle": "Carvedilol With Chemotherapy in Second Line Glioblastoma and Response of Circulating Tumor Cells", "OfficialTitle": "A Feasibility Study: Evaluating Carvedilol With Chemotherapy in Second Line Glioblastoma Multiforme and Response of Peripheral Glioma Circulating Tumor Cells", "OverallStatus": "TERMINATED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2019-07-19", "PrimaryCompletionDate": "2020-08-21", "Interventions": [ { "Name": "Carvedilol", "Type": "DRUG", "Description": "Carvedilol orally starting at 6.25 mg and increasing to 12.5 mg if tolerated after 1-2 weeks for a total of 4 cycles of treatment.", "OtherNames": [ "Coreg", "Coreg CR" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "West Virginia University", "LeadSponsorClass": "OTHER", "Collaborators": [ "West Virginia Clinical and Translational Science Institute" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03360708", "BriefTitle": "Vaccine Therapy in Treating Patients With Recurrent Glioblastoma", "OfficialTitle": "Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2013-11-27", "PrimaryCompletionDate": "2021-06-02", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine", "Type": "BIOLOGICAL", "Description": "Given ID", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Mayo Clinic", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04945148", "BriefTitle": "Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide", "OfficialTitle": "Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-05-10", "PrimaryCompletionDate": "2028-05", "Interventions": [ { "Name": "Metformin", "Type": "DRUG", "Description": "Metformin 2000 to 3000mg/day daily will be started by 6 weeks after histological diagnosis and 7 days before the start of RT-TMZ and will continue until progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiation IMRT", "Type": "RADIATION", "Description": "2 Gy x 5 days for 6 weeks to be started 7 days after first administration of Metformin and by 7 weeks after histological diagnosis", "OtherNames": [ "Radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "75 mg/m² daily from first to last day of radiation (IMRT) and then 150 to 200 mg/m² x 5 days every 28 days cycle for 12 cycles", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Hopital Foch", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute, France" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02335918", "BriefTitle": "A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors", "OfficialTitle": "A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2015-01", "PrimaryCompletionDate": "2018-12-12", "Interventions": [ { "Name": "Combination of varlilumab and nivolumab", "Type": "DRUG", "Description": "Phase I: Varlilumab dosing will be dependent on the cohort assigned in combination with 3 mg/kg of nivolumab every two weeks.\n\nPhase II: Patients with CRC, RCC or GBM enrolled in Phase ll will receive 3.0 mg/kg of varlilumab in combination with 240 mg of nivolumab every 2 weeks. Patients with SCCHN or ovarian cancer will receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks, in combination with 240 mg of nivolumab every 2 weeks.\n\nPatients may be discontinued from receiving study treatment based on the results of disease assessments or if experiencing intolerable side effects.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } } ], "LeadSponsorName": "Celldex Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Bristol-Myers Squibb" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [ "Checkpoint inhibitor" ] } }, { "NCTId": "NCT00100880", "BriefTitle": "Lenalidomide in Treating Young Patients With Recurrent, Progressive, or Refractory CNS Tumors", "OfficialTitle": "A Phase I Trial of CC-5013 (Lenalidomide) in Pediatric Patients With Recurrent or Refractory Primary CNS Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-11", "PrimaryCompletionDate": "2010-11", "Interventions": [ { "Name": "lenalidomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CC-5013", "IMiD-1", "Revlimid" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "perfusion-weighted magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "PW-MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "diffusion-weighted magnetic resonance imaging", "Type": "PROCEDURE", "Description": "Correlative studies", "OtherNames": [ "diffusion-weighted MRI" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00004004", "BriefTitle": "Procarbazine in Treating Patients With Recurrent Brain Tumor", "OfficialTitle": "A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "1999-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "procarbazine hydrochloride", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00093613", "BriefTitle": "Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma", "OfficialTitle": "A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2004-12", "PrimaryCompletionDate": "2010-10", "Interventions": [ { "Name": "sorafenib tosylate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "BAY 43-9006", "BAY 43-9006 Tosylate Salt", "BAY 54-9085", "Nexavar", "SFN" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02176720", "BriefTitle": "Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma", "OfficialTitle": "Randomized Metabolic Response Monitoring Trial in Patients With Suspected Recurrence of Glioblastoma FDOPA PET-CT", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2014-05", "PrimaryCompletionDate": "2016-03", "Interventions": [ { "Name": "FDOPA PET", "Type": "DRUG", "Description": "\\[18F\\]FDOPA radiopharmaceutical will be intravenousely injected for PET-CT scanning of the brain.", "OtherNames": [ "FDOPA PET-CT", "Fluorine-18-L-dihydroxyphenylalanine", "Fluorine-18-L-dihydroxyphenylalanine PET", "Fluorine-18-L-dihydroxyphenylalanine PET-CT", "[18F]FDOPA", "[18F]FDOPA PET", "[18F]FDOPA PET-CT" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "The Methodist Hospital Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "University of California, Los Angeles" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00704080", "BriefTitle": "A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas", "OfficialTitle": "A Phase 1 Dose-Escalation Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Subjects With Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2008-08", "PrimaryCompletionDate": "2012-02", "Interventions": [ { "Name": "XL765 (SAR245409)", "Type": "DRUG", "Description": "Gelatin capsules supplied in 5-mg, 10-mg, and 50-mg strengths; continuous daily dosing", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days", "OtherNames": [ "Temodar®" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Sanofi", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00841555", "BriefTitle": "Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma", "OfficialTitle": "A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2009-02-13", "PrimaryCompletionDate": "2013-02-13", "Interventions": [ { "Name": "temozolomide", "Type": "DRUG", "Description": "Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.\n\nDose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment", "OtherNames": [ "Temodar", "Temodal" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Hypofractionated radiation therapy", "Type": "RADIATION", "Description": "Patients will undergo HIMRT", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Intensity-modulated radiation therapy", "Type": "RADIATION", "Description": "Patients undergo HIMRT", "OtherNames": [ "IMRT" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Ohio State University Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05909618", "BriefTitle": "Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases", "OfficialTitle": "An Open Label Phase 2 Study of Intravenously Administered Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2023-07-11", "PrimaryCompletionDate": "2028-07-30", "Interventions": [ { "Name": "Crizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO]", "Type": "DRUG", "Description": "5 mg/kg solution for injection", "OtherNames": [ "crizanlizumab" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "Name": "Nivolumab 10 MG/1 ML Intravenous Solution [OPDIVO]", "Type": "DRUG", "Description": "3 mg/mL solution for injection", "OtherNames": [ "nivolumab" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "MET", "PD-1" ], "classes": [] } } ], "LeadSponsorName": "Sheba Medical Center", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [ "Prof. Ronit Satchi-Fainaro, Director, Cancer Biology Research Center, Tel Aviv University, Tel Aviv, Israel." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "MET", "PD-1" ], "classes": [] } }, { "NCTId": "NCT00354913", "BriefTitle": "Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma", "OfficialTitle": "A Phase II Study of Imatinib Mesylate Plus Hydroxyurea in the Treatment of Patients With Recurrent/Progressive Meningioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-05", "PrimaryCompletionDate": "2009-03", "Interventions": [ { "Name": "hydroxyurea", "Type": "DRUG", "Description": "Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydroxyurea at the same time that they take their prescribed imatinib mesylate, however, a 30-60 minute interval between agents is acceptable, if required for practical or other compliance issues.", "OtherNames": [ "Droxia", "Hydrea", "Hydroxycarbamide" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "imatinib mesylate", "Type": "DRUG", "Description": "Imatinib administered orally on daily, continuous basis. Imatinib doses of 400mg/600mg administered once daily, whereas daily doses of 800mg/greater administered as equally divided dose taken twice day.\n\nDose for Imatinib:\n\nPatients receiving p450-inducing antiepileptic drugs:500mg twice day Patients not receiving p450-inducing antiepileptic drugs:400mg/day.\n\nIf patients who were not on Cytochrome P450, family 3, subfamily A (CYP3A) enzyme-reducing anti-epileptic drug (EIAED) when originally enrolled must initiate CYP3A enzyme-inducing anti-epileptic drug while on study, study regimen will remain same for minimum of 2 wks before pt transitions to dosing as specified for patients on anti-epileptic drug. If patients originally enrolled must discontinue all EIAEDs while on study, in interest of patient safety, dosing of study regimen will transition to that of patients not on anti-epileptics immediately.", "OtherNames": [ "Gleevec" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Novartis Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT01814813", "BriefTitle": "Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery", "OfficialTitle": "A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC #725085, ALLIANCE IND # 15380) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2013-06-19", "PrimaryCompletionDate": "2017-04-03", "Interventions": [ { "Name": "HSPPC-96", "Type": "BIOLOGICAL", "Description": "intradermal infusion", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "bevacizumab", "Type": "DRUG", "Description": "intravenous", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Alliance for Clinical Trials in Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "Agenus Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01508117", "BriefTitle": "Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients", "OfficialTitle": "A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2011-08", "PrimaryCompletionDate": "2012-10", "Interventions": [ { "Name": "Axitinib", "Type": "DRUG", "Description": "5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity", "OtherNames": [ "AG-013736" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy", "OtherNames": [ "Hypofractionated radiation therapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "University of Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02049489", "BriefTitle": "A Study of ICT-121 Dendritic Cell Vaccine in Recurrent Glioblastoma", "OfficialTitle": "Immunological Targeting of CD-133 in Recurrent Glioblastoma: A Multi-center Phase I Translational and Clinical Study of an Autologous CD-133 DC Vaccine", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2013-12", "PrimaryCompletionDate": "2017-03", "Interventions": [ { "Name": "ICT-121 DC vaccine", "Type": "BIOLOGICAL", "Description": "autologous dendritic cells pulsed with peptide antigens", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Precision Life Sciences Group", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00022360", "BriefTitle": "Taurolidine in Treating Patients With Recurrent or Progressive Glioma", "OfficialTitle": "An Open-Label Dose-Ranging Study of the Safety of Taurolidine 2% Solution Administered Intravenously to Patients With Recurrent or Progressive High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2001-05", "PrimaryCompletionDate": "2001-10", "Interventions": [ { "Name": "taurolidine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Memorial Sloan Kettering Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00823797", "BriefTitle": "Bendamustine Hydrochloride in Treating Patients With Recurrent or Progressive Anaplastic Glioma", "OfficialTitle": "A Phase II Study of Bendamustine in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2008-10", "PrimaryCompletionDate": "2015-12", "Interventions": [ { "Name": "Bendamustine Hydrochloride", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "Bendamustin Hydrochloride", "Cytostasan Hydrochloride", "Levact", "Ribomustin", "SyB L-0501", "Treanda" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Washington", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "National Comprehensive Cancer Network" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04324840", "BriefTitle": "A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma", "OfficialTitle": "A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2020-07-10", "PrimaryCompletionDate": "2024-07-09", "Interventions": [ { "Name": "CC-90010", "Type": "DRUG", "Description": "Specified dose on specified days", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Specified dose on specified days", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Specified dose on specified days", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Celgene", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00003574", "BriefTitle": "Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors", "OfficialTitle": "A Multi-Center, Open-Label Clinical Study to Evaluate the Safety and Performance of the Proxima GliaSite RTS, a Radiation Delivery System, in Patients With Recurrent Malignant Brain Tumors Undergoing Surgical Resection", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "1999-04", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "surgical procedure", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "brachytherapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "intraoperative radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "iodine I 125", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT07042620", "BriefTitle": "A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery", "OfficialTitle": "Ultrasound Imaging in Brain Tumour Surgery With the Use of SonoClear® System Mimicking Brain Tissue.", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-06", "PrimaryCompletionDate": "2026-03", "Interventions": [ { "Name": "SonoClear(R) System", "Type": "DEVICE", "Description": "The SonoClear(R) System is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "SonoClear AS", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "OTHER", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02829723", "BriefTitle": "A Study of BLZ945 Single Agent or BLZ945 in Combination With PDR001 in Advanced Solid Tumors", "OfficialTitle": "A Phase I/II, Open-label, Multi-center Study of the Safety and Efficacy of BLZ945 as Single Agent and in Combination With PDR001 in Adults Patients With Advanced Solid Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2016-10-21", "PrimaryCompletionDate": "2022-12-01", "Interventions": [ { "Name": "BLZ945", "Type": "DRUG", "Description": "BLZ945 administered orally as a capsule. Up to five alternative dosing schedules were evaluated: once per day (QD) 7 days on/7 days off (i.e., administer BLZ945 for 7 days and suspend for 7 days), QD 4 days on/10 days off, twice per day (BID) 4 days on/10 days off, once weekly (Q1W) QD and Q1W BID.\n\nEach cycle consisted of 28 days.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "PDR001", "Type": "DRUG", "Description": "PDR001 400 mg administered via intravenous (i.v.) infusion every 4 weeks (Q4W)", "OtherNames": [ "spartalizumab" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00036959", "BriefTitle": "ABT-751 in Treating Young Patients With Refractory Solid Tumors", "OfficialTitle": "Phase I Trial and Pharmacokinetic Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, on a 7 Day and 21 Day Dosing Schedule in Pediatric Patients With Refractory Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2002-03", "PrimaryCompletionDate": "2010-02", "Interventions": [ { "Name": "ABT-751", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Institutes of Health Clinical Center (CC)", "LeadSponsorClass": "NIH", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06336291", "BriefTitle": "A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence", "OfficialTitle": "A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-05-22", "PrimaryCompletionDate": "2026-06", "Interventions": [ { "Name": "L19TNF", "Type": "DRUG", "Description": "7 μg/kg", "OtherNames": [ "onfekafusp alfa" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "L19TNF", "Type": "DRUG", "Description": "10 μg/kg", "OtherNames": [ "onfekafusp alfa" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "L19TNF", "Type": "DRUG", "Description": "13 μg/kg", "OtherNames": [ "onfekafusp alfa" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "90 mg/m2", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Lomustine", "Type": "DRUG", "Description": "110 mg/m2", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Philogen S.p.A.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT05086497", "BriefTitle": "WBSI Guided Personalized Delivery of TTFields", "OfficialTitle": "Whole-Brain Spectroscopy Guided Personalized Mapping of Transducer Arrays for Glioblastoma Patients Receiving Tumor Treating Fields", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-01-15", "PrimaryCompletionDate": "2026-06-30", "Interventions": [ { "Name": "Whole Brain Spectroscopy Imaging Array Mapping Layout", "Type": "DIAGNOSTIC_TEST", "Description": "All study participants will receive whole brain spectroscopy imaging as a part of MRI study time points. Participants assigned to the advanced MR imaging array mapping layout study arm will receive tumor treating fields mapping from Optune that is created from the spectroscopy sequences or advanced MR imaging. Participants assigned to the conventional array mapping layout will still receive advanced imaging sequences or spectroscopy imaging at all time points.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Abramson Cancer Center at Penn Medicine", "LeadSponsorClass": "OTHER", "Collaborators": [ "NovoCure Ltd.", "National Institutes of Health (NIH)", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05957679", "BriefTitle": "MRE Evaluation for Spinal Cord Tumor Surgery: Stiffness and Adhesion Assessment", "OfficialTitle": "Preoperative Evaluation of Tumor Stiffness and Adhesion in Spinal Cord Tumor Using Magnetic Resonance Elastography", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2023-01-01", "PrimaryCompletionDate": "2025-09-01", "Interventions": [ { "Name": "Magnetic Resonance Elastography", "Type": "DIAGNOSTIC_TEST", "Description": "Undergo MRE and routine MRI", "OtherNames": [ "MRE" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Assessment and Recording", "Type": "PROCEDURE", "Description": "Undergo grading and recording of tumor stiffness and adhesion during surgery", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Shengjing Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01480479", "BriefTitle": "Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma", "OfficialTitle": "An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE3" ], "StartDate": "2011-11", "PrimaryCompletionDate": "2016-11", "Interventions": [ { "Name": "Rindopepimut (CDX-110) with GM-CSF", "Type": "DRUG", "Description": "Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.\n\nEach dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF.", "OtherNames": [ "CDX-110 with sargramostim (GM-CSF) (Leukine®)" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.", "OtherNames": [ "Temodar", "Temodal" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "Name": "KLH", "Type": "DRUG", "Description": "Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Celldex Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04991870", "BriefTitle": "Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM", "OfficialTitle": "A Phase I Clinical Trial With a Window-of-Opportunity Component of Engineered NK Cells Containing Deleted TGF-ßR2 and NR3C1 in Recurrent Grade 4 Astrocytoma (Glioblastoma)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2023-04-28", "PrimaryCompletionDate": "2027-01-31", "Interventions": [ { "Name": "Cord Blood-derived Expanded Allogeneic Natural Killer Cells", "Type": "BIOLOGICAL", "Description": "Given CB-NK-TGF-betaR2-/NR3C1- intratumorally", "OtherNames": [ "Allogeneic CB-derived Ex vivo-expanded NK Cells", "CB-derived Expanded Allogeneic NK Cells", "UCB-derived Expanded Allogeneic NK Cells", "Umbilical Cord Blood-derived Expanded Allogeneic Natural Killer Cells" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Surgical Resection" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01663012", "BriefTitle": "Phase II NKTR-102 In Bevacizumab-Resistant High Grade Glioma", "OfficialTitle": "A Phase II, Single Arm, Open Label Study Of NKTR-102 In Bevacizumab-Resistant High Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2012-07", "PrimaryCompletionDate": "2015-02", "Interventions": [ { "Name": "Etirinotecan pegol", "Type": "DRUG", "Description": null, "OtherNames": [ "NKTR-102" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Lawrence Recht", "LeadSponsorClass": "OTHER", "Collaborators": [ "Nektar Therapeutics" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04488783", "BriefTitle": "Potentiation of Chemotherapy in Brain Tumors by Zinc", "OfficialTitle": "Potentiation of Chemotherapy in Brain Tumors by Zinc", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2020-07-30", "PrimaryCompletionDate": "2022-07-30", "Interventions": [ { "Name": "zinc and ascorbate", "Type": "DIETARY_SUPPLEMENT", "Description": "oral zinc and ascorbate", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Sheba Medical Center", "LeadSponsorClass": "OTHER_GOV", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT03975959", "BriefTitle": "Memory Perception Assessment in Central/Non-central Nervous System Cancers", "OfficialTitle": "Prospective and Retrospective Memory Perception Assessment in Central/Non-central Nervous System Cancers", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2019-05-10", "PrimaryCompletionDate": "2024-06-27", "Interventions": [ { "Name": "QMRP questionnaire", "Type": "OTHER", "Description": "a single consultation for test and questionnaires for a duration of 20 minutes", "OtherNames": [ "HADS questionnaire", "MFI questionnaire", "MOCA test", "FAB test" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Institut du Cancer de Montpellier - Val d'Aurelle", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "FACTORIAL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02805179", "BriefTitle": "A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma", "OfficialTitle": "Phase II Study of High Dose Radiotherapy and Concurrent Temozolomide Using Biologically-Based Target Volume Definition in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-09-22", "PrimaryCompletionDate": "2020-02-06", "Interventions": [ { "Name": "High Dose Radiation", "Type": "RADIATION", "Description": "Radiation will be delivered once daily for a total of 30 fractions, five days per week.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Patients will receive concurrent temozolomide (75 mg/m\\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "University of Michigan Rogel Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01259869", "BriefTitle": "A Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression", "OfficialTitle": "A Phase II Study of PX-866 in Patients With Glioblastoma Multiforme at Time of First Relapse or Progression", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2011-04-01", "PrimaryCompletionDate": "2014-10-29", "Interventions": [ { "Name": "PX-866", "Type": "DRUG", "Description": "1 cycle = 8 weeks on study PX-866 - 8mg PO Daily", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "NCIC Clinical Trials Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "Cascadian Therapeutics Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00165477", "BriefTitle": "Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-09", "PrimaryCompletionDate": "2007-11", "Interventions": [ { "Name": "lenalidomide", "Type": "DRUG", "Description": "Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects", "OtherNames": [ "Revlimid" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation", "Type": "RADIATION", "Description": "Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks", "OtherNames": [ "XRT" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dana-Farber Cancer Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "Celgene Corporation", "Beth Israel Deaconess Medical Center", "Brigham and Women's Hospital", "Massachusetts General Hospital", "University of Virginia" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00012038", "BriefTitle": "Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors", "OfficialTitle": "A Phase I/II Trial Of MGI114 For Treatment Of Patients With Recurrent Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2001-07", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "irofulven", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "New Approaches to Brain Tumor Therapy Consortium", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02718443", "BriefTitle": "VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma", "OfficialTitle": "VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma to Examine Safety, Tolerability, Immune and Biomarker Response to the Investigational VEGFR-2 DNA Vaccine VXM01", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-05", "PrimaryCompletionDate": "2017-08", "Interventions": [ { "Name": "VXM01", "Type": "DRUG", "Description": "Oral immunotherapy targeting VEGFR2", "OtherNames": [], "modality": [ "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [ "EGFR", "VEGF" ], "classes": [] } } ], "LeadSponsorName": "Vaximm GmbH", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [ "EGFR", "VEGF" ], "classes": [] } }, { "NCTId": "NCT00003476", "BriefTitle": "Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors", "OfficialTitle": "Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "1996-03", "PrimaryCompletionDate": "2012-01", "Interventions": [ { "Name": "Antineoplaston therapy (Atengenal + Astugenal)", "Type": "DRUG", "Description": "Children with a primary malignant brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).", "OtherNames": [ "A10 (Atengenal); AS2-1 (Astugenal)" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Burzynski Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00979017", "BriefTitle": "Avastin/Temozolomide/Irinotecan for Unresectable/Multifocal Glioblastoma Multiforme", "OfficialTitle": "Avastin in Combination With Temozolomide and Irinotecan for Unresectable or Multifocal Glioblastoma Multiformes and Gliosarcomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-11", "PrimaryCompletionDate": "2011-02", "Interventions": [ { "Name": "Avastin", "Type": "DRUG", "Description": "Avastin, by intravenous infusion, 10 mg/kg every 14 days", "OtherNames": [ "Avastin (bevacizumab)" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Oral temozolomide at 200 mg/m2 daily for 5 days", "OtherNames": [ "Temodar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "Name": "Irinotecan", "Type": "DRUG", "Description": "Irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)", "OtherNames": [ "CPT-11, Camptosar" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Katy Peters", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT06410248", "BriefTitle": "Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma", "OfficialTitle": "A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2024-07-23", "PrimaryCompletionDate": "2029-05-12", "Interventions": [ { "Name": "Biospecimen Collection", "Type": "PROCEDURE", "Description": "Undergo collection of blood samples", "OtherNames": [ "Biological Sample Collection", "Biospecimen Collected", "Specimen Collection" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo MRI", "OtherNames": [ "Magnetic Resonance", "Magnetic Resonance Imaging (MRI)", "Magnetic resonance imaging (procedure)", "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MR", "MR Imaging", "MRI", "MRI Scan", "MRIs", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging", "sMRI", "Structural MRI" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Questionnaire Administration", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Resection", "Type": "PROCEDURE", "Description": "Undergo surgical resection", "OtherNames": [ "Surgical Resection" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CCRG-81045", "Gliotem", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temizole", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Triapine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "3-aminopyridine-2-carboxaldehyde thiosemicarbazone", "3-AP", "3-Apct", "OCX-0191", "OCX-191", "OCX191", "PAN-811" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)", "BrainUp Inc" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00672243", "BriefTitle": "Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme", "OfficialTitle": "Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2007-04", "PrimaryCompletionDate": "2008-09", "Interventions": [ { "Name": "Erlotinib + sirolimus", "Type": "DRUG", "Description": "Erlotinib \\& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.", "OtherNames": [ "sirolimus - Rapamune", "erlotinib - Tarceva - OSI-774" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Genentech, Inc.", "OSI Pharmaceuticals" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "mTOR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02808364", "BriefTitle": "Personalized Cellular Vaccine for Recurrent Glioblastoma (PERCELLVAC2)", "OfficialTitle": "Personalized Cellular Vaccine Therapy in Treating Patients With Recurrent Glioblastoma (PerCellVac2)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-03-01", "PrimaryCompletionDate": "2017-10-31", "Interventions": [ { "Name": "Personalized cellular vaccine", "Type": "BIOLOGICAL", "Description": "Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.", "OtherNames": [ "Tumor antigen pulsed DC autologous cellular vaccine" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Guangdong 999 Brain Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Beijing Tricision Biotherapeutics Inc", "Zhuhai Trinomab Pharmaceutical Co., Ltd.", "Jinan University Guangzhou" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00813943", "BriefTitle": "Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma and Unmethylated Gene Promoter Status", "OfficialTitle": "Cilengitide in Subjects With Newly Diagnosed Glioblastoma and Unmethylated MGMT Gene Promoter - a Multicenter, Open-label Phase II Study, Investigating Two Cilengitide Regimens in Combination With Standard Treatment (Temozolomide With Concomitant Radiation Therapy, Followed by Temozolomide Maintenance Therapy). [The CORE Study]", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-03", "PrimaryCompletionDate": "2013-02", "Interventions": [ { "Name": "Cilengitide (2-times weekly)", "Type": "DRUG", "Description": "Cilengitide 2000 milligram (mg) will be administered intravenously twice weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "cilengitide (5-times weekly)", "Type": "DRUG", "Description": "Cilengitide 2000 milligram (mg) will be administered intravenously 5-times weekly over 1 hour infusion from Weeks -1 to 77 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. If considered beneficial in the opinion of the Investigator, continuation of cilengitide treatment will be optional in subjects without disease progression and after Week 77 since start of treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Temozolomide (TMZ) 75 milligram per square meter \\[mg/m\\^2\\] will be administered intravenously once daily from Week 1 to 6. From Week 11 onwards, TMZ will be given as maintenance treatment at a dose of 150-200 mg/m\\^2 for consecutive 5 days every 4 weeks until Week 34 or until disease progression.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "Name": "Radiotherapy", "Type": "RADIATION", "Description": "Radiation therapy (RTX) at a dose of 2 gray (Gy) per fraction will be given once daily, 5 days per week from Week 1 to 6, total dose 60 Gy.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "EMD Serono", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Merck KGaA, Darmstadt, Germany" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04657315", "BriefTitle": "Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients", "OfficialTitle": "Investigator-initiated and Open-labeled Clinical Trial for Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-06-24", "PrimaryCompletionDate": "2022-12-22", "Interventions": [ { "Name": "MSC11FCD", "Type": "DRUG", "Description": "Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10\\^7, 3x10\\^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery.\n\nConcomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day\n\nDirections:\n\nAdministration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery.\n\nRoute of administration: Oral administration", "OtherNames": [ "Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD)" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "CHA University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Ajou University School of Medicine" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06105619", "BriefTitle": "A Study of PLB1001 Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).", "OfficialTitle": "A Randomized, Controlled, Open, Multicenter, Phase II/III Clinical Study to Evaluate the Safety and Efficacy of Vebreltinib Enteric Capsules in the Treatment of sGBM/IDH Mutant Glioblastoma Patients With the ZM Fusion Gene (FUGEN).", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2018-10-08", "PrimaryCompletionDate": "2023-04-01", "Interventions": [ { "Name": "PLB1001", "Type": "DRUG", "Description": "PLB1001 is a capsule in the form of 300mg,twice daily.", "OtherNames": [ "Vebreltinib" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "100-150mg/m2/d,day 1 to 7 and day 15 to 22 of each 28-day cycle", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "Name": "Cisplatin combined with Etoposide", "Type": "DRUG", "Description": "Cisplatin:80-100mg/m2/3 days,28 days/cycle Etoposide:100mg/m2/d,3 days,28 days/cycle", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "IDH" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "Beijing Pearl Biotechnology Limited Liability Company", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "IDH" ], "classes": [ "Alkylating agent", "Kinase inhibitor" ] } }, { "NCTId": "NCT02010606", "BriefTitle": "Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma", "OfficialTitle": "Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2014-01-08", "PrimaryCompletionDate": "2019-01-23", "Interventions": [ { "Name": "Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy", "Type": "BIOLOGICAL", "Description": "Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab", "Type": "BIOLOGICAL", "Description": "Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Cedars-Sinai Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT01475006", "BriefTitle": "AMG 595 First-in-Human in Recurrent Gliomas", "OfficialTitle": "A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 595 in Subjects With Recurrent Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-02", "PrimaryCompletionDate": "2016-04", "Interventions": [ { "Name": "AMG 595", "Type": "DRUG", "Description": "AMG 595 is an antibody drug conjugate that binds to EGFRvIII.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "Amgen", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT04440358", "BriefTitle": "Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM", "OfficialTitle": "Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption (BBBD) With Microbubbles for the Treatment of Recurrent Glioblastoma (rGBM) in Subjects Undergoing Carboplatin Monotherapy", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2020-10-13", "PrimaryCompletionDate": "2023-11-30", "Interventions": [ { "Name": "Exablate BBBD", "Type": "DEVICE", "Description": "BBB opening via Exablate Neuro Type 2 system to deliver carboplatin", "OtherNames": [ "Exablate Neuro" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Carboplatin", "Type": "DRUG", "Description": "Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "InSightec", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01295632", "BriefTitle": "Safety and Tolerability of Different Dose Combinations of Ridaforolimus With MK-2206 or MK-0752 for Participants With Advanced Cancer (MK-8669-049)", "OfficialTitle": "Phase I Parallel Protocol of MK-8669 (Ridaforolimus) + MK-2206 and MK-8669 (Ridaforolimus) + MK-0752 Doublets (MK-MK) in Patients With Advanced Cancer", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2011-02", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "ridaforolimus", "Type": "DRUG", "Description": "10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week.", "OtherNames": [ "MK-8669" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MK-0752", "Type": "DRUG", "Description": "300 mg capsule, orally, 6 capsules per dose, once each week.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "MK-2206", "Type": "DRUG", "Description": "Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Merck Sharp & Dohme LLC", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00253487", "BriefTitle": "Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas", "OfficialTitle": "A Pilot Study of Temozolomide and O-Benzylguanine for Treatment of High-Grade Glioma, Using Autologous Peripheral Blood Stem Cells Genetically Modified for Chemoprotection", "OverallStatus": "COMPLETED", "Phase": [ "NA" ], "StartDate": "2005-08", "PrimaryCompletionDate": "2012-08", "Interventions": [ { "Name": "O6-benzylguanine", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "busulfan", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "adjuvant therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "autologous bone marrow transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "peripheral blood stem cell transplantation", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Children's Hospital Medical Center, Cincinnati", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01285414", "BriefTitle": "Verubulin, Radiation Therapy, and Temozolomide to Treat Patients With Newly Diagnosed Glioblastoma Multiforme", "OfficialTitle": "A Phase 2 Study of Verubulin With Radiation Therapy and Temozolomide in Subjects Newly Diagnosed With Glioblastoma Multiforme", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2010-12", "PrimaryCompletionDate": "2012-03", "Interventions": [ { "Name": "Verubulin", "Type": "DRUG", "Description": "Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide \\& Radiation Therapy", "OtherNames": [ "Azixa", "MPC-6827" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide & Radiation Therapy", "Type": "DRUG", "Description": "Temozolomide \\& Radiation Therapy", "OtherNames": [ "Temodar", "TMZ", "Radiotherapy" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Myrexis Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04677049", "BriefTitle": "Study of Niacin in Glioblastoma", "OfficialTitle": "A Phase I-II Study of Niacin in Patients With Newly Diagnosed Glioblastoma Receiving Concurrent Radiotherapy and Temozolomide Followed by Monthly Temozolomide", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2021-03-18", "PrimaryCompletionDate": "2026-12-31", "Interventions": [ { "Name": "Niacin CRT", "Type": "DRUG", "Description": "A controlled release technology (CRT) tablet of Niacin", "OtherNames": [ "Nicotinic acid", "Vitamin B3" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "AHS Cancer Control Alberta", "LeadSponsorClass": "OTHER", "Collaborators": [ "Tom Baker Cancer Centre" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00132158", "BriefTitle": "ZD1839 and Oral Irinotecan in Treating Young Patients With Refractory Solid Tumors", "OfficialTitle": "A Dose Finding Study (Phase I) of the Combination of ZD1839 (Iressa®) and an Oral Formulation of Irinotecan (Camptosar™) in Children With Refractory Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2005-09", "PrimaryCompletionDate": "2011-10", "Interventions": [ { "Name": "Irinotecan (Camptosar), Gefitinib (Iressa)", "Type": "DRUG", "Description": "See Detailed Description for treatment plan.", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "St. Jude Children's Research Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "AstraZeneca" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT00019058", "BriefTitle": "Radiation Therapy in Treating Patients With Glioblastoma", "OfficialTitle": "A PHASE I STUDY OF COMBINED RADIATION RESPONSE MODIFIERS EMPLOYING HYDROXYUREA AND PENTOXIFYLLINE FOR TREATMENT OF GLIOBLASTOMA", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "1995-04", "PrimaryCompletionDate": null, "Interventions": [ { "Name": "chemotherapy", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "hydroxyurea", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "pentoxifylline", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": null, "DesignInterventionModel": null, "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06691308", "BriefTitle": "WL276 CAR-T Cell Therapy for CD276 Positive Recurrent or Progressive Glioblastoma Patients", "OfficialTitle": "Clinical Study Evaluating the Safety and Efficacy of WL276 CAR-T Cell Therapy in CD276 Positive Recurrent or Progressive Glioblastoma Patients", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2024-11-12", "PrimaryCompletionDate": "2027-05-31", "Interventions": [ { "Name": "WL276 CAR-T cells", "Type": "COMBINATION_PRODUCT", "Description": "This study intends to include 6 subjects, with 3 subjects receiving 5 \\* 10 \\^ 6 CAR-T Cells and 3 subjects receiving 1 \\* 10 \\^ 7 CAR-T Cells at different doses", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beijing Immunochina Medical Science & Technology Co., Ltd.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00919737", "BriefTitle": "Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme", "OfficialTitle": "A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2009-06", "PrimaryCompletionDate": "2011-04", "Interventions": [ { "Name": "NPC-08", "Type": "DRUG", "Description": "Polifeprosan 20 with Carmustine 3.85%", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Nobelpharma", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00458731", "BriefTitle": "Bevacizumab and Cediranib Maleate in Treating Patients With Metastatic or Unresectable Solid Tumor, Lymphoma, Intracranial Glioblastoma, Gliosarcoma or Anaplastic Astrocytoma", "OfficialTitle": "Phase I Clinical Trial Evaluating the Toxicity, Pharmacokinetics and Biological Effect of Intravenous Bevacizumab (Avastin TM) in Combination With Escalating Doses of Oral AZD2171 for Patients With Advanced Malignancies", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2007-05", "PrimaryCompletionDate": "2013-12", "Interventions": [ { "Name": "bevacizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "anti-VEGF humanized monoclonal antibody", "anti-VEGF monoclonal antibody", "Avastin", "rhuMAb VEGF" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "cediranib maleate", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "AZD2171", "Recentin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT02062372", "BriefTitle": "Spatial Analysis and Validation of Glioblastoma on 7 T MRI", "OfficialTitle": "Spatial Analysis and Validation of Glioblastoma on 7 T MRI", "OverallStatus": "TERMINATED", "Phase": [ "NA" ], "StartDate": "2014-12-10", "PrimaryCompletionDate": "2018-02-05", "Interventions": [ { "Name": "7 T MRI", "Type": "DEVICE", "Description": "Overview Technical DetailsField strength: 7 Tesla Bore size: 60 cm System length: 317,5 cm RF power: 7,5 kW / 8x1 kW Gradient strength: SC 72 Gradients (max. 70 mT/m @ 200 T/m/s) Helium Consumption: Zero Helium boil-off technology", "OtherNames": [ "Siemens MAGNETOM 7" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Biopsy", "Type": "PROCEDURE", "Description": "During surgery patients will receive standard biopsies plus one study biopsy from a region of interest. The neuro-surgeon will determine the feasibility of the extra biopsy and the optimal biopsy tract. A screen capture from the neuronavigation system will be saved for each biopsy to relate the findings on 3T and 7T MRI to histopathology.", "OtherNames": [ "Brain biopsy", "Tumor sampling" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Maastricht Radiation Oncology", "LeadSponsorClass": "OTHER", "Collaborators": [ "The Limburg University Fund" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05039281", "BriefTitle": "Atezolizumab and Cabozantinib for the Treatment of Recurrent Glioblastoma", "OfficialTitle": "Phase I/II Study to Evaluate the Safety and Clinical Efficacy of Atezolizumab (Anti-PD-L1) in Combination With Cabozantinib in Patients With Recurrent Glioblastoma (rGBM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2022-09-23", "PrimaryCompletionDate": "2027-12-31", "Interventions": [ { "Name": "Atezolizumab", "Type": "BIOLOGICAL", "Description": "Given IV", "OtherNames": [ "MPDL 3280A", "MPDL 328OA", "MPDL-3280A", "MPDL3280A", "MPDL328OA", "RG7446", "RO5541267", "Tecentriq" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-L1" ], "classes": [ "Checkpoint inhibitor", "Kinase inhibitor" ] } }, { "Name": "Cabozantinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "PD-L1" ], "classes": [ "Checkpoint inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "PD-L1" ], "classes": [ "Checkpoint inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT01124539", "BriefTitle": "Study of AR-67 in Adult Patients With Recurrence of Glioblastoma Multiforme (GBM) or Gliosarcoma", "OfficialTitle": "A Phase 2 Study of AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin) in Adult Patients With Recurrence of Glioblastoma Multiforme (GBM) or Gliosarcoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2009-12", "PrimaryCompletionDate": "2014-09", "Interventions": [ { "Name": "AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin)", "Type": "DRUG", "Description": "IV AR-67 administered once daily for 5 days on an every 21-day cycle", "OtherNames": [ "AR67", "formerly DB-67", "formerly DB67" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Arno Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00720356", "BriefTitle": "Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma", "OfficialTitle": "A Phase II Study of Bevacizumab and Erlotinib After Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma Without MGMT Promoter Methylation", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2009-07-07", "PrimaryCompletionDate": "2014-06-24", "Interventions": [ { "Name": "bevacizumab", "Type": "DRUG", "Description": "10mg/kg administered intravenously every 2 weeks", "OtherNames": [ "Avastin" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "Name": "erlotinib hydrochloride", "Type": "DRUG", "Description": "150 mg/daily orally", "OtherNames": [ "erlotinib", "CP-358, 774", "Tarceva" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "M.D. Anderson Cancer Center" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "MGMT", "VEGF" ], "classes": [ "Alkylating agent", "Angiogenesis inhibitor", "Kinase inhibitor" ] } }, { "NCTId": "NCT04051606", "BriefTitle": "Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma", "OfficialTitle": "Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2019-07-31", "PrimaryCompletionDate": "2024-03-20", "Interventions": [ { "Name": "Regorafenib", "Type": "DRUG", "Description": "Regorafenib is a monotherapy during the study, oral administration at 160 mg once daily will be administered for 3 weeks on /1 week off.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Case Comprehensive Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT05843253", "BriefTitle": "Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant", "OfficialTitle": "Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-08-22", "PrimaryCompletionDate": "2029-08-31", "Interventions": [ { "Name": "Ribociclib", "Type": "DRUG", "Description": "Ribociclib PO qd on days 1-21", "OtherNames": [ "Kisqali" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "PI3K", "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "Everolimus", "Type": "DRUG", "Description": "Everolimus PO qd on days 1-28", "OtherNames": [ "Afinitor" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "PI3K", "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "Name": "Temozolomide (TMZ)", "Type": "DRUG", "Description": "Temozolomide PO qd on days 1-5 for the first 13 cycles", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "CDK", "PI3K", "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } } ], "LeadSponsorName": "Nationwide Children's Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "CDK", "PI3K", "mTOR" ], "classes": [ "Alkylating agent", "Cell cycle inhibitor" ] } }, { "NCTId": "NCT01977677", "BriefTitle": "Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma", "OfficialTitle": "A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2014-11", "PrimaryCompletionDate": "2017-11", "Interventions": [ { "Name": "radiation therapy", "Type": "RADIATION", "Description": "Undergo radiation therapy", "OtherNames": [ "irradiation", "radiotherapy", "therapy, radiation" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "SCH 52365", "Temodal", "Temodar", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "plerixafor", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "AMD 3100", "Mozobil" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "laboratory biomarker analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [ "pharmacological studies" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Lawrence Recht", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00120939", "BriefTitle": "Study of Motexafin Gadolinium and Docetaxel for Advanced Cancer", "OfficialTitle": "Phase I Trial of Motexafin Gadolinium (MGd) and Docetaxel Chemotherapy in the Treatment of Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": null, "PrimaryCompletionDate": null, "Interventions": [ { "Name": "Motexafin Gadolinium", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Pharmacyclics LLC.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04222309", "BriefTitle": "Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)", "OfficialTitle": "Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE1" ], "StartDate": "2020-01-06", "PrimaryCompletionDate": "2026-01-31", "Interventions": [ { "Name": "Laparoscopically harvested omental free flap", "Type": "PROCEDURE", "Description": "Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Northwell Health", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00024557", "BriefTitle": "Histologic Effect/Safety of Pre/Post-Operative IL13-PE38QQR in Recurrent Resectable Supratentorial Malignant Glioma Patients", "OfficialTitle": "Phase I Study to Assess the Histologic Effect and Safety of Pre-Operative and Post-Operative Infusions of IL13-PE38QQR Cytotoxin in Patients With Recurrent Resectable Supratentorial Malignant Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2001-06", "PrimaryCompletionDate": "2006-06", "Interventions": [ { "Name": "IL13-PE38QQR", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "targeted fusion protein therapy", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "surgery", "Type": "PROCEDURE", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "INSYS Therapeutics Inc", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05116137", "BriefTitle": "The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors", "OfficialTitle": "The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors (RESIST)", "OverallStatus": "ENROLLING_BY_INVITATION", "Phase": [ "NA" ], "StartDate": "2022-03-01", "PrimaryCompletionDate": "2025-12-31", "Interventions": [ { "Name": "Circuit-based resistance exercise (CRT)", "Type": "BEHAVIORAL", "Description": "CRT is a common training method used to foster aerobic fitness, muscular endurance and strength, as well as neuromuscular adaptations in one workout. CRT is comprised of several sets of different exercises with little rest in between each set.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Nova Scotia Health Authority", "LeadSponsorClass": "OTHER", "Collaborators": [ "Canadian Cancer Society (CCS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT05538572", "BriefTitle": "A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors", "OfficialTitle": "A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2022-12-27", "PrimaryCompletionDate": "2024-06-26", "Interventions": [ { "Name": "PRT3645", "Type": "DRUG", "Description": "PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Prelude Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT01051557", "BriefTitle": "Temsirolimus and Perifosine in Treating Patients With Recurrent or Progressive Malignant Glioma", "OfficialTitle": "Phase I/II Trial of Temsirolimus and Perifosine for Recurrent or Progressive Malignant Gliomas", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2010-01-27", "PrimaryCompletionDate": "2018-11-16", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } }, { "Name": "Perifosine", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "4-[[Hydroxy(octadecyloxy)phosphinyl]oxy]-1,1-dimethylpiperidinium, Inner Salt", "D21266", "Octadecylphosphopiperidine" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "MET", "mTOR" ], "classes": [] } }, { "Name": "Temsirolimus", "Type": "DRUG", "Description": "Given IV", "OtherNames": [ "CCI-779", "CCI-779 Rapamycin Analog", "Cell Cycle Inhibitor 779", "Rapamycin Analog", "Rapamycin Analog CCI-779", "Torisel" ], "modality": [ "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo cytoreductive surgery", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "mTOR" ], "classes": [] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET", "mTOR" ], "classes": [ "Cell cycle inhibitor" ] } }, { "NCTId": "NCT06001281", "BriefTitle": "Predictive Value of Soluble CD146 in Glioblastoma Patients", "OfficialTitle": "Predictive Value of Soluble CD146 in Patients With Recurrent Glioblastoma Treated by Bevacizumab", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2024-01-30", "PrimaryCompletionDate": "2026-12", "Interventions": [ { "Name": "plasma collection", "Type": "OTHER", "Description": "Plasma samples will be prospectively collected at relevant time points during patient treatment.", "OtherNames": [], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "Assistance Publique Hopitaux De Marseille", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "BASIC_SCIENCE", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT07031765", "BriefTitle": "Peds CHAMP1ON - Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade for RecurreNt Pediatric High-Grade Glioma", "OfficialTitle": "Peds CHAMP1ON - Combinatorial Hematopoietic Stem Cell And Monoclonal Antibody PD-1 Blockade Phase 1 Trial for RecurreNt Pediatric High-Grade Glioma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-07-25", "PrimaryCompletionDate": "2030-12", "Interventions": [ { "Name": "exHSC", "Type": "BIOLOGICAL", "Description": "Ex vivo expanded CD34+ hematopoietic stem cells (exHSCs) at a targeted dose of 2.5 x 106 cells/kg (or maximal achievable dose, with a minimum deliverable dose of 1/10 target dose; max dose 1.0 x 108 total cells for patients ≥40kg).", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Nivolumab", "Type": "DRUG", "Description": "Nivolumab 3mg/kg once every 2 weeks, max dose 240mg. Nivolumab will be administered on day 1 and day 15 of each cycle for a total of 10 cycles. Nivolumab may continue for a total two years of therapy, at the discretion of the treating team.", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } }, { "Name": "Resection or biopsy", "Type": "PROCEDURE", "Description": "Patients must be candidates for standard of care surgical resection or biopsy.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "PD-1" ], "classes": [] } } ], "LeadSponsorName": "University of Florida", "LeadSponsorClass": "OTHER", "Collaborators": [ "Florida Department of Health" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "PD-1" ], "classes": [] } }, { "NCTId": "NCT03548571", "BriefTitle": "Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy", "OfficialTitle": "Open Label Randomized Phase II/III Trial of Dendritic Cell Immunotherapy Against Cancer Stem Cells in Glioblastoma Patients Receiving Standard Therapy (DEN-STEM)", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2018-04-26", "PrimaryCompletionDate": "2025-12-01", "Interventions": [ { "Name": "Dendritic cell immunization", "Type": "BIOLOGICAL", "Description": "Intradermal injection", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Adjuvant temozolomide", "Type": "DRUG", "Description": "After a 4-week break, patients were then to receive up to six cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days at 150 mg per square meter for the first cycle and thereafter increase to 200 mg per square meter beginning with the second cycle.", "OtherNames": [ "Standard therapy" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Oslo University Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06147505", "BriefTitle": "XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)", "OfficialTitle": "Clinical Study of Evaluating the Safety and Initial Efficacy of XS005 Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)", "OverallStatus": "SUSPENDED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2023-10-29", "PrimaryCompletionDate": "2025-11-02", "Interventions": [ { "Name": "XS005 Injection", "Type": "BIOLOGICAL", "Description": "Treatment on this study includes XS005 infusions over an 16 week period. Phase 1： dose escalation (3+3); Phase 2 : dose of recommended phase 2 dose(RP2D).", "OtherNames": [ "XS005" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Dushu Lake Hospital Affiliated to Soochow University", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05236036", "BriefTitle": "Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma", "OfficialTitle": "A Phase 1/1b Adaptive Dose Escalation Study of Mycophenolate Mofetil (MMF) in Combination With Standard of Care for Patients With Glioblastoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2022-08-08", "PrimaryCompletionDate": "2026-01-12", "Interventions": [ { "Name": "Mycophenolate Mofetil", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "CellCept", "MMF" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Quality-of-Life Assessment", "Type": "OTHER", "Description": "Ancillary studies", "OtherNames": [ "Quality of Life Assessment" ], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Radiation Therapy", "Type": "RADIATION", "Description": "Receive radiation therapy", "OtherNames": [ "Cancer Radiotherapy", "ENERGY_TYPE", "Irradiate", "Irradiated", "Irradiation", "Radiation", "Radiation Therapy, NOS", "Radiotherapeutics", "Radiotherapy", "RT", "Therapy, Radiation" ], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given Orally (PO)", "OtherNames": [ "CCRG-81045", "Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-", "M & B 39831", "M and B 39831", "Methazolastone", "RP-46161", "SCH 52365", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Northwestern University", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT01260467", "BriefTitle": "Memantine for Recurrent Glioblastoma", "OfficialTitle": "A Phase II Study of Memantine in the Treatment of Recurrent Glioblastoma", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2010-11", "PrimaryCompletionDate": "2014-04", "Interventions": [ { "Name": "memantine", "Type": "DRUG", "Description": "10 milligrams orally twice a day", "OtherNames": [ "Namenda" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Rochester", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05563272", "BriefTitle": "89Zr-girentuximab for PET Imaging of CAIX Positive Solid Tumors", "OfficialTitle": "Phase 2, Multicenter, Open-Label Study of 89Zr-girentuximab for PET/CT Imaging of Tumors Likely to Express High Levels of CAIX", "OverallStatus": "TERMINATED", "Phase": [ "PHASE2" ], "StartDate": "2023-06-06", "PrimaryCompletionDate": "2025-05-09", "Interventions": [ { "Name": "89Zr-girentuximab for PET/CT imaging of CAIX positive tumors", "Type": "DIAGNOSTIC_TEST", "Description": "On Day 0, participants will receive a single administration of 89Zr-girentuximab (37 Megabecquerel (MBq) \\[1mCi\\] ± 10%, containing a mass dose of 10 mg of girentuximab).", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Telix Pharmaceuticals (Innovations) Pty Ltd", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00456612", "BriefTitle": "Radiosurgery for Glioblastoma Multiforme", "OfficialTitle": "Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-02", "PrimaryCompletionDate": "2010-12", "Interventions": [ { "Name": "CyberKnife", "Type": "PROCEDURE", "Description": "Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Beth Israel Deaconess Medical Center", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05324501", "BriefTitle": "A Study of Intra-tumoral Administered MTX110 in Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase I Open Label Ascending Dose Study to Assess the Feasibility and Safety of Intermittent Infusions of MTX110 Administered by Convection-Enhanced Delivery (CED) in Patients With Recurrent Glioblastoma (rGBM) (MAGIC-G1)", "OverallStatus": "TERMINATED", "Phase": [ "PHASE1" ], "StartDate": "2022-10-19", "PrimaryCompletionDate": "2024-09-10", "Interventions": [ { "Name": "MTX110", "Type": "DRUG", "Description": "Soluble panobinostat", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Programmable pump and catheter system", "Type": "DEVICE", "Description": "To allow Convection-Enhanced Delivery (CED)", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Biodexa Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT04552977", "BriefTitle": "A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma", "OfficialTitle": "A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma", "OverallStatus": "UNKNOWN", "Phase": [ "PHASE2" ], "StartDate": "2020-09", "PrimaryCompletionDate": "2021-08", "Interventions": [ { "Name": "fluzoparil", "Type": "DRUG", "Description": "a PARP1 inhibitor", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "PARP" ], "classes": [ "Alkylating agent" ] } }, { "Name": "temozolomide", "Type": "DRUG", "Description": "an alkylating chemotherapeutic agent", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [ "ALK" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Shandong Cancer Hospital and Institute", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [ "ALK", "PARP" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT02885272", "BriefTitle": "FDG PET Imaging in Diagnosing Patients With Glioblastoma", "OfficialTitle": "Dual Time Point FDG PET Imaging Optimization for the Evaluation of Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "EARLY_PHASE1" ], "StartDate": "2016-10-28", "PrimaryCompletionDate": "2022-07-12", "Interventions": [ { "Name": "Computed Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT scans", "OtherNames": [ "CAT", "CAT Scan", "Computerized Axial Tomography", "computerized tomography", "CT", "CT SCAN", "tomography" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Fludeoxyglucose F-18", "Type": "RADIATION", "Description": "Given IV", "OtherNames": [ "18FDG", "FDG", "fludeoxyglucose F 18", "Fludeoxyglucose F18", "Fluorine-18 2-Fluoro-2-deoxy-D-Glucose", "Fluorodeoxyglucose F18" ], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Undergo standard of care MRI", "OtherNames": [ "Magnetic Resonance Imaging Scan", "Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance", "MRI", "MRI Scan", "NMR Imaging", "NMRI", "Nuclear Magnetic Resonance Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Positron Emission Tomography", "Type": "PROCEDURE", "Description": "Undergo PET/CT scans", "OtherNames": [ "Medical Imaging, Positron Emission Tomography", "PET", "PET Scan", "Positron Emission Tomography Scan", "Positron-Emission Tomography", "proton magnetic resonance spectroscopic imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "M.D. Anderson Cancer Center", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure", "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00006388", "BriefTitle": "Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme", "OfficialTitle": "A Phase II Trial of High Dose Tamoxifen For The Treatment of Newly Diagnosed Supratentorial Glioblastoma Multiforme (GBM)", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2000-12", "PrimaryCompletionDate": "2003-10", "Interventions": [ { "Name": "tamoxifen citrate", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "radiation therapy", "Type": "RADIATION", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Radiation Therapy Oncology Group", "LeadSponsorClass": "NETWORK", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02062827", "BriefTitle": "Genetically Engineered HSV-1 Phase 1 Study for the Treatment of Recurrent Malignant Glioma", "OfficialTitle": "A Phase 1 Study of M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2013-11-25", "PrimaryCompletionDate": "2022-09", "Interventions": [ { "Name": "M032 (NSC 733972)", "Type": "BIOLOGICAL", "Description": "A single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "University of Alabama at Birmingham", "LeadSponsorClass": "OTHER", "Collaborators": [ "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT05100641", "BriefTitle": "AV-GBM-1 vs Control as Adjunctive Therapy Following Surgery and RT/TMZ in Newly Diagnosed GBM", "OfficialTitle": "Randomized Phase 3 Trial of Standard Care Plus AV-GBM-1 vs Autologous Monocytes as Adjunctive Therapy Following Primary Surgery Plus Concurrent Radiation-temozolomide in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE3" ], "StartDate": "2024-01", "PrimaryCompletionDate": "2028-03", "Interventions": [ { "Name": "AV-GBM-1", "Type": "BIOLOGICAL", "Description": "Therapeutic autologous dendritic cell vaccine", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Autologous monocytes", "Type": "BIOLOGICAL", "Description": "Autologous monocyte control", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Aivita Biomedical, Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03137888", "BriefTitle": "Spectroscopic MRI-Guided Radiation Therapy Planning in Glioblastoma", "OfficialTitle": "Pilot Study of Spectroscopic MRI-Guided, Dose-Escalated Radiation Therapy for Newly-Diagnosed Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2017-09-20", "PrimaryCompletionDate": "2024-09-09", "Interventions": [ { "Name": "Dose-Escalated Radiation Therapy", "Type": "RADIATION", "Description": "Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks", "OtherNames": [ "RT", "Radiation Therapy" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Spectroscopic Magnetic Resonance Imaging", "Type": "PROCEDURE", "Description": "Patients will undergo sMRI scans within a 14 day window prior to starting treatment", "OtherNames": [ "sMRI", "MRSI", "Magnetic Resonance Spectroscopic Imaging" ], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Temozolomide", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Methazolastone", "Temcad", "Temodal", "Temodar", "Temomedac", "TMZ" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Emory University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Johns Hopkins University", "University of Miami", "National Cancer Institute (NCI)", "National Institutes of Health (NIH)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [ "MET" ], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT06264388", "BriefTitle": "DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma", "OfficialTitle": "A Biomarker-Guided Phase 2 Study of DB107-RRV (Retroviral Replicating Vector) Combined With DB107-Flucytosine Extended-Release Tablets in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE2" ], "StartDate": "2024-05-01", "PrimaryCompletionDate": "2034-05-01", "Interventions": [ { "Name": "DB107-RRV", "Type": "DRUG", "Description": "Patients will undergo surgery to remove as much of the high-grade glioma (HHG) tumor as possible and will receive combination intravenous (IV) and adaptive repeat intratumoral delivery of DB107-RRV in the vein (IV) and in the walls of the cavity that remains where tumor is removed.", "OtherNames": [], "modality": [ "Device/Procedure", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "DB107-FC", "Type": "DRUG", "Description": "Patients will start taking DB107-FC three times by mouth every day for a period of seven days, which is one cycle of treatment. A cycle of treatment is medication taken on a set schedule with periods of rest in between. Patients will wait five weeks before taking the next seven day course of DB107-FC. The first dose of DB107-FC will be taken at the hospital or clinic; afterward, patients will take the doses of DB107-FC at home. Patients will take DB107-FC for up to 12 months after surgery.", "OtherNames": [ "Ancobon", "Ancotil" ], "modality": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Ashish Shah", "LeadSponsorClass": "OTHER", "Collaborators": [ "Denovo Biopharma LLC", "National Cancer Institute (NCI)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Viral/Gene Therapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT00301873", "BriefTitle": "Zoledronate in Preventing Osteoporosis in Patients With Primary Malignant Glioma", "OfficialTitle": "Phase II Study of Zometa (Zoledronic Acid) to Prevent Osteoporosis in Patients With Brain Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2006-05", "PrimaryCompletionDate": "2011-02", "Interventions": [ { "Name": "IV Zometa", "Type": "DRUG", "Description": "Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.", "OtherNames": [ "zolondronic acid" ], "modality": [ "Other" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Novartis", "National Institute of Neurological Disorders and Stroke (NINDS)" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "SUPPORTIVE_CARE", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT02342379", "BriefTitle": "TH-302 in Combination With Bevacizumab for Glioblastoma", "OfficialTitle": "A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2015-05", "PrimaryCompletionDate": "2019-01-04", "Interventions": [ { "Name": "Bevacizumab", "Type": "DRUG", "Description": "10mg/kg", "OtherNames": [ "Avastin" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "Name": "TH-302", "Type": "DRUG", "Description": "670mg/m2", "OtherNames": [ "MSC2491899A" ], "modality": [ "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } } ], "LeadSponsorName": "The University of Texas Health Science Center at San Antonio", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "VEGF" ], "classes": [ "Angiogenesis inhibitor" ] } }, { "NCTId": "NCT04250922", "BriefTitle": "LAM561 With RT and TMZ for Adults With Glioblastoma", "OfficialTitle": "A Randomized, Double-blind, Placebo-controlled Adjuvant Trial in Newly Diagnosed Primary Glioblastoma Subjects to Assess the Efficacy and Safety of LAM561 in Combination With Radiotherapy and Temozolomide Standard of Care Treatment.", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE2", "PHASE3" ], "StartDate": "2019-12-01", "PrimaryCompletionDate": "2026-01-15", "Interventions": [ { "Name": "LAM561", "Type": "DRUG", "Description": "Subjects in Arm B will receive orally LAM561 during the Chemoradiation Phase.\n\nSubjects in Arm B will receive LAM561 orally during the Maintenance (Adjuvant) Phase. Patients will continue to be administered with LAM561/Placebo after cycle 6 of the monotherapy phase until end of study. Adjuvant treatment will be discontinued upon determination of tumour progression as defined by RANO criteria, unacceptable toxicity, or refusal to continue study treatment.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "TMZ", "Type": "DRUG", "Description": "TMZ will be administered at 75 mg/m2, orally, once daily, continuously from Day 1 of radiotherapy to the last day of radiation for a maximum of 49 days.\n\nDuring the Maintenance (Adjuvant) Phase, all subjects will receive oral TMZ 150 - 200 mg/m2 once daily on Days 1 - 5 of each 28-day cycle for 6 cycles.", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "RT", "Type": "RADIATION", "Description": "During the Chemoradiation Phase, all subjects will undergo focal RT, with one treatment given daily 5 days per week over approximately 6 weeks (and no more than 7 weeks).", "OtherNames": [], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Laminar Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Laboratory Corporation of America", "Northern Institute for Cancer Research, Newcastle", "Theradis pharma", "LIPODOM THERAPEUTICS" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT07209241", "BriefTitle": "Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM", "OfficialTitle": "Phase Ib, Open-Label Study of CART-EGFR-IL13Rα2 Cells Administered Following Lymphodepleting Chemotherapy or Prior to Surgical Resection in Patients With EGFR-Amplified Recurrent Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-12-03", "PrimaryCompletionDate": "2042-11-01", "Interventions": [ { "Name": "CART-EGFR-IL13Ra2 T cells", "Type": "BIOLOGICAL", "Description": "CART-EGFR-IL13Ra2 cells are autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2.", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy" ], "moa": { "targets": [ "EGFR" ], "classes": [] } } ], "LeadSponsorName": "University of Pennsylvania", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [] } }, { "NCTId": "NCT07185880", "BriefTitle": "A Phase 1 Study of the Safety and Tolerability of MT-125 in GBM Patients", "OfficialTitle": "A Phase 1 Dose Escalation and Randomized Expansion Study of the Safety, Tolerability, and Pharmacokinetics of MT-125 Monotherapy With Radiation in Patients With Newly Diagnosed Glioblastoma", "OverallStatus": "NOT_YET_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2025-11-01", "PrimaryCompletionDate": "2026-08-31", "Interventions": [ { "Name": "MT-125", "Type": "DRUG", "Description": "This is an investigational new drug under IND 170975.", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Myosin Therapeutics Inc.", "LeadSponsorClass": "INDUSTRY", "Collaborators": [ "Mayo Clinic" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "SEQUENTIAL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT02540161", "BriefTitle": "Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma", "OfficialTitle": "Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2016-02-01", "PrimaryCompletionDate": "2019-07-10", "Interventions": [ { "Name": "Sym004 - 18 mg/kg", "Type": "DRUG", "Description": "Sym004 was dosed at 18 mg/kg intravenously every two weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } }, { "Name": "Sym004 - 24 mg/kg", "Type": "DRUG", "Description": "Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.", "OtherNames": [], "modality": [ "Other" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Annick Desjardins", "LeadSponsorClass": "OTHER", "Collaborators": [ "Symphogen A/S" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Other" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT01324479", "BriefTitle": "Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors", "OfficialTitle": "A Phase I Open-label Dose Escalation Study With Expansion to Assess the Safety and Tolerability of INC280 in Patients With c-MET Dependent Advanced Solid Tumors", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2012-02-29", "PrimaryCompletionDate": "2017-07-04", "Interventions": [ { "Name": "INC280", "Type": "DRUG", "Description": null, "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [ "MET" ], "classes": [] } } ], "LeadSponsorName": "Novartis Pharmaceuticals", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [ "MET" ], "classes": [] } }, { "NCTId": "NCT00379080", "BriefTitle": "Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma", "OfficialTitle": "A Feasibility Assessment and a Phase I/II Trial of MLN518 for Treatment of Patients With Recurrent Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1", "PHASE2" ], "StartDate": "2007-01", "PrimaryCompletionDate": "2012-09", "Interventions": [ { "Name": "conventional surgery", "Type": "PROCEDURE", "Description": "Undergo surgery", "OtherNames": [ "MLN518" ], "modality": [ "Device/Procedure", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "tandutinib", "Type": "DRUG", "Description": "Given orally", "OtherNames": [ "CT53518" ], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "pharmacological study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Tissue samples", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT02101905", "BriefTitle": "Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma", "OfficialTitle": "Drug Distribution and Pharmacodynamic Study of Pulsatile Lapatinib in Surgically Accessible EGFR-Amplified Recurrent High-Grade Glioma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2016-11-07", "PrimaryCompletionDate": "2021-10-19", "Interventions": [ { "Name": "Laboratory Biomarker Analysis", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lapatinib", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "GSK572016", "GW 2016", "GW 572016", "GW-572016", "GW2016", "GW572016" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Lapatinib Ditosylate", "Type": "DRUG", "Description": "Given PO", "OtherNames": [ "Tykerb" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Pharmacological Study", "Type": "OTHER", "Description": "Correlative studies", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "Name": "Therapeutic Conventional Surgery", "Type": "PROCEDURE", "Description": "Undergo surgical resection of tumor", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } } ], "LeadSponsorName": "National Cancer Institute (NCI)", "LeadSponsorClass": "NIH", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [ "EGFR" ], "classes": [ "Kinase inhibitor" ] } }, { "NCTId": "NCT03679754", "BriefTitle": "Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102", "OfficialTitle": "Protocol ATI001-102 Expansion Substudy: Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma", "OverallStatus": "COMPLETED", "Phase": [ "PHASE1" ], "StartDate": "2018-09-05", "PrimaryCompletionDate": "2019-04-02", "Interventions": [ { "Name": "Ad-RTS-hIL-12", "Type": "BIOLOGICAL", "Description": "* 2.0 x 10\\^11 viral particles (vp) per injection\n* intratumoral injection of Ad-RTS-hIL-12", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } }, { "Name": "veledimex", "Type": "DRUG", "Description": "* 20mg/day\n* 15 oral daily doses of veledimex", "OtherNames": [], "modality": [ "Immunotherapy" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "Alaunos Therapeutics", "LeadSponsorClass": "INDUSTRY", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Immunotherapy" ], "trial_moa": { "targets": [], "classes": [] } }, { "NCTId": "NCT06850766", "BriefTitle": "The Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma", "OfficialTitle": "A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma", "OverallStatus": "RECRUITING", "Phase": [ "NA" ], "StartDate": "2025-05-08", "PrimaryCompletionDate": "2026-11", "Interventions": [ { "Name": "Morning administration of TMZ", "Type": "OTHER", "Description": "Administration of TMZ within 2 hours of waking", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Evening administration of TMZ", "Type": "OTHER", "Description": "Administration of TMZ within 2 hours of bedtime", "OtherNames": [], "modality": [ "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Ottawa Hospital Research Institute", "LeadSponsorClass": "OTHER", "Collaborators": [ "The Ottawa Hospital" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "RANDOMIZED", "DesignInterventionModel": "PARALLEL", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT04968366", "BriefTitle": "Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery", "OfficialTitle": "Phase I Clinical Study of Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery", "OverallStatus": "ACTIVE_NOT_RECRUITING", "Phase": [ "PHASE1" ], "StartDate": "2021-07-30", "PrimaryCompletionDate": "2024-04-30", "Interventions": [ { "Name": "Autologous dendritic cells pulsed with multiple neoantigen peptides.", "Type": "BIOLOGICAL", "Description": "Each dosage of Dendritic Cells (DC) vaccine contains 2-10 million DC cells, loaded with 5-20 tumor neoantigen peptides. DC vaccine will be administered (i.d) around lymph nodes of the groin and Axillary at 2nd, 3rd, 4th, 7th and 11th week after the completion of concurrent Temozolomide chemoradiation. After 5 injections, the investigator will review subject's tolerance and compliance; and, decide whether to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of Temozolomide adjuvant chemotherapy to assess the patient's immune response. According to the result, investigators will decide whether to perform 1-2 more treatment cycles (5-8 injections/cycle) to strengthen the effectiveness", "OtherNames": [], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "Name": "Temozolomide adjuvant chemotherapy", "Type": "DRUG", "Description": "Temozolomide is administered as the standard-of-care adjuvant chemotherapy, in combination with the DC vaccines to treat the enrolled patients.", "OtherNames": [ "the standard-of-care adjuvant chemotherapy for GBM patients" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Beijing Tiantan Hospital", "LeadSponsorClass": "OTHER", "Collaborators": [ "ZhongSheng BioTech Inc." ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT00616005", "BriefTitle": "Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide", "OfficialTitle": "Phase II Treatment of Adults With Primary Malignant Glioma With Irinotecan Plus Temozolomide", "OverallStatus": "COMPLETED", "Phase": [ "PHASE2" ], "StartDate": "2005-11", "PrimaryCompletionDate": "2007-07", "Interventions": [ { "Name": "Temodar and Irinotecan", "Type": "DRUG", "Description": "Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle \\& every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-days 1, 8, 22, \\& 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.", "OtherNames": [ "Temodar - Temozolomide", "Irinotecan - Camptosar - CPT11" ], "modality": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "moa": { "targets": [], "classes": [ "Alkylating agent" ] } } ], "LeadSponsorName": "Duke University", "LeadSponsorClass": "OTHER", "Collaborators": [ "Pfizer" ], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NON_RANDOMIZED", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "TREATMENT", "trial_modalities": [ "Device/Procedure", "Immunotherapy", "Small Molecule" ], "trial_moa": { "targets": [], "classes": [ "Alkylating agent" ] } }, { "NCTId": "NCT03401866", "BriefTitle": "Multi-site Validation and Application of a Consensus DSC-MRI Protocol", "OfficialTitle": "Multi-site Validation and Application of a Consensus Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) Protocol", "OverallStatus": "UNKNOWN", "Phase": [ "NA" ], "StartDate": "2018-02", "PrimaryCompletionDate": "2021-01", "Interventions": [ { "Name": "DSC-MRI", "Type": "DIAGNOSTIC_TEST", "Description": "The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes.\"", "OtherNames": [], "modality": [ "Device/Procedure" ], "moa": { "targets": [], "classes": [] } } ], "LeadSponsorName": "St. Joseph's Hospital and Medical Center, Phoenix", "LeadSponsorClass": "OTHER", "Collaborators": [], "StudyType": "INTERVENTIONAL", "DesignAllocation": "NA", "DesignInterventionModel": "SINGLE_GROUP", "DesignPrimaryPurpose": "DIAGNOSTIC", "trial_modalities": [ "Device/Procedure" ], "trial_moa": { "targets": [], "classes": [] } } ] }