drugset / Trial / NCT02137759
MRSI to Predict Response to RT/TMZ ± Belinostat in GBM
Phase 2
Unknown
29 enrolled
Emory University
Johns Hopkins University · collabNational Cancer Institute (NCI) · collabNational Institute of Neurological Disorders and Stroke (NINDS) · collabNational Institutes of Health (NIH) · collabSpectrum Pharmaceuticals, Inc · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-05-07
- Primary completion
- 2023-08-15
- Completion
- 2024-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belinostat | Small molecule | — | Intravenous |
| Background | Temozolomide | Small molecule | — | Oral |