Brain Tumor and Neuro-Oncology Research
Primary GBM
TRIDENT/EF-32
Investigator:Jay Jiguang Zhu, MD, PHD
Lead CRC:Connie Okon
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:Active
NCT#:4471844
DB102-01
Investigator:Jay Jiguang Zhu, MD, PHD
Lead CRC:William Guerra
Purpose:一个随机、双盲、安慰剂对照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:Active
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:成人患者没有已知IDH突变;证明diagnosis of glioblastoma; MGMT promoter without methylation confirmed by central pathology review.
Enrollment Status:Active
NCT#:4396860
BBI-DSP7888
Investigator:Jay Jiguang Zhu, MD, PHD
Lead CRC:William Guerra
Purpose:A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy
Key Inclusion Criteria:Adult patients with diagnosis of supratentorial GBM Radiographic evidence of first recurrence or progression of GBM following surgery and chemoradiation.
Enrollment Status:Active
NCT#:3149003
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:Active
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:Not yet enrolling. Please check back in January 2022.
NCT#:4729959
DC Cells GBM
Investigator:Yoshua Esquenazi, MD
Lead CRC:William Guerra
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:Not yet enrolling. Please check back in February 2022.
NCT#:4552886
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Recurring GBM
CNS-201
Investigator:Jay Jiguang Zhu, MD, PHD
Lead CRC:Connie Okon
Purpose: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 (WHO Grade IV) After Failure of Standard First Line Therapy.
Key Inclusion Criteria:A diagnosis of GBM. Recurrent GBM as evaluated by RANO criteria. The tumor is localized supratentorially. The lesion (or sum of lesions) does not exceed 50 cm3 in volume. Tumor isocitrate ehydrogenase (IDH) mutation status as well as O[6]-methylguanine-DNA methyltransferase (MGMT) methylation status must be available
Enrollment Status:Active
NCT#: 4762069
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Brain Metastases
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:Actively enrolling
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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:Actively enrolling
NCT#:3994796
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A071801
Investigator:Mark Amsbaugh, MD
Purpose:Phase III trial of post-surgical single refraction stereotactic radiosurgery compared with fractionated stereotactic radiosurgery for resected metastatic brain disease.
Key Inclusion Criteria:Resected brain metastasis must be non-CNS primary site. ≤3 unresected brain metastases at the time of screening. Unresected lesions must measure <4.0cm in size.
Enrollment Status:Actively enrolling
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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)
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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:Actively enrolling
Contact Us:To learn more about this trial,please fill out this short online form »