Brain Tumor and Neuro-Oncology Research
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: Upcoming
Contact Us: To learn more about this trial, please fill out this short online form »
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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TRIDENT/EF-32
Investigator: Jay Jiguang Zhu, MD, PHD
Lead CRC: Eva Schumann
Purpose: A Pivotal Randomized, Open-Label study of Optune Concomitant with Radiation Therapy and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma
Key Inclusion Criteria: Adult patients with confirmed diagnosis of GBM; Recovered from maximal debulking surgery; Planned treatment with RT/TMZ followed by maintenance TMZ.
Enrollment Status: Closed
NCT#: 4471844
DB102-01
Investigator: Jay Jiguang Zhu, MD, PHD
Lead CRC: Eva Schumann
Purpose: 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.
Key Inclusion Criteria: Histologically proven, newly diagnosed supratentorial glioblastoma (IDH mutant is excluded) based on the WHO classification (2016) which includes gliosarcoma (GS); prior diagnosis of lower grade astrocytoma that has been upgraded to histologically confirmed glioblastoma is eligible if chemotherapy and radiation therapy treatment-naïve. DGM1 biomarker status (positive or negative) is available prior to randomization.
Enrollment Status: Closed
NCT#: 3776071
NRG BN007
Investigator: Jay Jiguang Zhu, MD, PHD
Lead CRC: William Guerra
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
EAF 151
Investigator: Jay Jiguang Zhu, MD, PHD
Lead CRC: William Guerra
Purpose: Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma.
Key Inclusion Criteria: Recurrent glioblastoma patients planned to be treated with Bevacizumab.
Enrollment Status: Closed
NCT#: 3115333
NRG-BN010
Investigator: Mark Amsbaugh, PHD
Lead CRC: William Guerra
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
DC Cells GBM
Investigator: Yoshua Esquenazi, MD
Lead CRC: Eva Schumann
Purpose: A Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination with Standard Chemoradiation for the Adjuvant Treatment of Adult Glioblastoma.
Key Inclusion Criteria: Diagnosed with GBM deemed to be potentially resectable and who are deemed to be good candidate for postoperative adjuvant chemo and radiation therapy. Ability to adhere to the bi-weekly injections of DC vaccine regimen.
Enrollment Status: Closed
NCT#: 4552886
Recurring GBM
Upcoming: SC9-GBM-03
Investigator: Yoshua Esquenazi Levy, MD
Lead CRC: Mia Vu
Purpose: Recurrent Glioblastoma Surgically Implanted BBB Disrupter with Carboplatin
Enrollment Status: Enrolling Soon
NCT#: 05902169
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Brain Metastases
ReSPECT-LMD
Investigator: Jay-Jiguang Zhu, MD, PhD
Lead CRC: Austin Lu
Purpose: Determine the Safety and Efficacy 186RNL for Leptomeningeal Metastases.
Enrollment Status: Upcoming
NCT#: 01906385
Contact Us: To learn more about this trial, please fill out this short online form »
METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields (TTFields) for 1-10 brain metastases from non-small cell lung cancer (NSCLC)
Investigator: Jay-Jiguang Zhu, MD, PhD
Purpose: To test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-100M and supportive treatment compared to supportive treatment alone.
Key Inclusion Criteria: New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study, KPS≥ 70, 1 inoperable brain metastasis or 2– 10 brain lesions per screening MRI.
Enrollment Status: Closed
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
ABM
Investigator: Jay-Jiguang Zhu, MD, PHD
Lead CRC: Mia Vu
Purpose: ABM1310 Monotherapy for Advanced Solid Tumors with BRAF Mutation
Enrollment Status: Closed
NCT#: 04190628
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 »
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 Bangning.Yu@uth.tmc.edu, call (713) 500-7363 or please fill out this short online form »
CNS
NeMeRe Neoplastic Meningitis Registry
Investigator: Jay Jiguang Zhu, MD, PHD
Purpose: To collect information abut adults wit hNeoplastic Meningitis to better understadn the condition (collaborative study with Penn State)
Key Inclusion Criteria: 18 yrs and older with dx of neoplastic meningitis
Enrollment Status: Closed
Clinical Trials
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