Brain Tumor and Neuro-Oncology Research
EAF-223 (GABLE)
Purpose: Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial (GABLE)
Principal Investigator: Jay-Jiguang Zhu, MD, PHD.
Lead CRC: Austin Lu
Enrollment Status: Upcoming
NCT#: 06319027
Contact Us: To learn more about this trial, please fill out this short online form »
Primary GBM
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Investigator: Jay-Jiguang Zhu, MD, PHD
Lead CRC: Austin Lu
UTHealth Number: HSC-MS-23-0526
Purpose: ONC201 treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Trial Summary: Tests a treatment with oral ONC201 for people who have been newly diagnosed with a diffuse midline glioma (a brain tumor) following their initial radiation treatment.
Compound: Dordaviprone (ONC201)
Study Phase: 3
Sponsor: Chimerix, Inc.
Contact Us: To learn more about this trial, please fill out this short online form »
DC Cells GBM_EA
Investigator: Yoshua Esquenazi, MD
Lead CRC: Mia Vu
Purpose: Expanded Access Protocol for Dendritic Cell immunotherapy for GBM
Enrollment Status: Active
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GESTALT
Investigator: Yoshua Esquenazi Levy, MD
Lead CRC: Mia Vu
Purpose: GammaTile for newly diagnosed GBM.
Enrollment Status: Upcoming
NCT#: 05342883
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NRG BN007
Investigator: Jay Jiguang Zhu, MD, PHD
Purpose: A Randomized Phase II/III Open-Label Study of Ipilimumab and Nivolumab versus Temozolomide in Patients with Newly Diagnosed MGMT Unmethylated Glioblastoma.
Key Inclusion Criteria: Adult patients with no known IDH mutation; Proven diagnosis of glioblastoma; MGMT promoter without methylation confirmed by central pathology review.
Enrollment Status: Closed
NCT#: 4396860
NRG-BN010
Investigator: Mark Amsbaugh, PHD
Purpose: 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.
Key Inclusion Criteria: Histopathologically proven diagnosis of glioblastoma, OR molecular diagnosis of glioblastoma per c-IMPACT-NOW criteria. Tumor that is in first recurrence following prior first-line radiation therapy (prior dose ≥40Gy).
Enrollment Status: Closed
NCT#: 4729959
NRG-BN010
Investigator: Mark Amsbaugh, PHD
Purpose: 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.
Key Inclusion Criteria: Histopathologically proven diagnosis of glioblastoma, OR molecular diagnosis of glioblastoma per c-IMPACT-NOW criteria. Tumor that is in first recurrence following prior first-line radiation therapy (prior dose ≥40Gy).
Enrollment Status: Closed
NCT#: 4729959
NRG BN011
Purpose: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma.
Principal Investigator: Mark Amsbaugh, MD
Lead CRC: Mia Vu
Enrollment Status: Upcoming
NCT#: 05095376
EF-41 (KEYNOTE)
Purpose: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Principal Investigator: Jay-Jiguang Zhu, MD, PHD.
Lead CRC: TBD
Enrollment Status: Upcoming
NCT#: 06556563
Recurring GBM
SC9-GBM-03
Investigator: Yoshua Esquenazi Levy, MD
Lead CRC: Mia Vu
Purpose: Recurrent Glioblastoma Surgically Implanted BBB Disrupter with Carboplatin
Enrollment Status: Open
NCT#: 05902169
Contact Us: To learn more about this trial, please fill out this short online form »
Brain Metastases
A071701
Investigator: Jay-Jiguang Zhu, MD, PhD
Purpose: Genomically-guided treatment trial in brain metasteses.
Key Inclusion Criteria: Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor.
Enrollment Status: Closed
NCT#: 3994796
Genomically-Guided Treatment Trial in Brain Metastases
Investigator: Ankush Bhatia, MD
Lead CRC: Kristen Clemons
Purpose: To determine if patients with brain metastases harboring CDK, PI3K, NTRK/ROS1 inhibitors will predict sensitivity to these inhibitors, with targeted therapies.
Key Inclusion Criteria: Histologically confirmed metastatic disease to the brain from any solid tumor; No known leptomeningeal involvement; (concurrent administration of anticancer therapies and chemotherapy within 14 days prior to entering the study are excluded)
Contact Us: To learn more about this trial, please fill out this short online form »
BN-013 (SRS)
Purpose: Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain
Principal Investigator: Mark Amsbaugh, MD
Lead CRC: Mia Vu
Enrollment Status: Upcoming
NCT#: 06500455
Medulloblastoma
Fourth Ventricular Administration of Immune Checkpoint Inhibitor (Nivolumab) and Methotrexate or 5-Azacytidine for Recurrent Medulloblastoma, Ependymoma, and other CNS Malignancies
Investigator: David I. Sandberg, MD
Purpose: The study employs a novel means of treating these tumors: infusion of two agents directly into the fourth ventricle or tumor resection cavity rather than systemic intravenous delivery. All enrolled patients will receive infusions of Nivolumab, an immune checkpoint inhibitor. Patients with ependymoma will additionally receive infusions of 5-azacytidine, and patients with medulloblastoma and other tumors will additionally receive infusions of methotrexate. There will be no simultaneous systemic chemotherapy.
Key Inclusion Criteria: Open to patients age 2 to 80 with recurrent medulloblastoma, ependymoma, and certain other tumors that start or recur in the posterior fossa (back of the brain)
NCT#: 06466798; https://clinicaltrials.gov/study/NCT06466798
Contact Us: To learn more about this trial, email Bangning Yu, PhD, at [email protected], call (713) 500-7363 or please fill out this short online form »
Meningioma
SMO/AKT/NF2 (Meningioma)
Purpose: Phase II Trial Of SMO/AKT/NF2 Inhibitors In Progressive Meningiomas With SMO/AKT/NF2 Mutations.
Principal Investigator: Jay-Jiguang Zhu, MD, PHD.
Lead CRC: Mia Vu
NCT#: 02523014
Clinical Trials
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