Glioblastoma Multiforme of Brain Clinical Trial
Official title:
Quantitative Magnetic Resonance Spectroscopic Imaging (MRSI) to Predict Early Response to Standard Radiation Therapy (RT)/Temozolomide (TMZ) ± Belinostat Therapy in Newly-Diagnosed Glioblastomas (GBM)
In the first phase of this study (Cohort 1), the investigators will determine the feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the early determination of response to this new therapy.
Patients will be assigned to Cohort 1 (standard RT/TMZ) followed by entry to either Cohort 1 or Cohort 2a (standard RT/TMZ + dose finding for belinostat), followed by assignment to Cohort 2b (standard RT/TMZ + tolerable dose of belinostat). Patients will undergo MRSI scans before beginning treatment and then at several time points during treatment to look for the early response of their tumor to treatment. Blood and tumor samples will be used to measure the levels of certain markers within the cancer cells. Patients will also be assessed for the side effects they experience. Progression-free and overall survival outcomes will be recorded. Patients will also have assessment of their depressive symptoms, quality-of-life and neurocognitive function at several time points during and after therapy course. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03657576 -
Trial of C134 in Patients With Recurrent GBM
|
Phase 1 | |
Recruiting |
NCT05685004 -
Study of Neoantigen-specific Adoptive T Cell Therapy for Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
|
Phase 2/Phase 3 | |
Recruiting |
NCT05076513 -
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
|
Early Phase 1 | |
Active, not recruiting |
NCT03665545 -
Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT02474966 -
Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme: a Pilot Study
|
Phase 2 | |
Enrolling by invitation |
NCT03170141 -
Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
|
Phase 1 | |
Recruiting |
NCT04842513 -
Multi Peptide Vaccination With XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma
|
Phase 1 | |
Recruiting |
NCT04869449 -
Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas
|
Early Phase 1 | |
Recruiting |
NCT03633552 -
Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
|
Phase 3 | |
Not yet recruiting |
NCT05095441 -
A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma
|
Phase 1 | |
Completed |
NCT00003456 -
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT03047473 -
Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 2 | |
Enrolling by invitation |
NCT05116137 -
The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors
|
N/A | |
Recruiting |
NCT05627323 -
CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma
|
Phase 1 | |
Active, not recruiting |
NCT04968366 -
Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery
|
Phase 1 | |
Suspended |
NCT04222309 -
Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
|
Phase 1 | |
Not yet recruiting |
NCT06186440 -
Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT06283927 -
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
|
||
Recruiting |
NCT06146725 -
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
|
||
Recruiting |
NCT06273176 -
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
|