Brain Tumor and Neuro-Oncology Research
Primary GBM
ONC201
Investigator: Jay-Jiguang Zhu, MD, PHD
Lead CRC: Austin Lu
Purpose: ONC201 treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study
Compound: Dordaviprone (ONC201)
Study Phase: 3
Sponsor: Chimerix, Inc.
NCT#: 05580562
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
Contact Us: To learn more about this trial, please fill out this short online form »
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
Contact Us: To learn more about this trial, please fill out this short online form »
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 »
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
Please fill out the fields to receive information about an ongoing UTHealth Neurosciences clinical trial.