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MRSI to Predict Response to RT/TMZ ± Belinostat in GBM

NCT02137759 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Glioblastoma Multiforme of Brain

Interventions

RADIATION

Standard Radiation Therapy

Radiation therapy to 60 Gy

DRUG

Standard Temozolomide

Temozolomide given orally

DRUG

Belinostat

Belinostat dose to be determined, given intravenously over 30-45 minutes

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • Spectrum Pharmaceuticals, Inc

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • Hui-Kuo Shu, MD, PhD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-07
Primary Completion
2023-08-15
Completion
2024-08-15

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02137759 on ClinicalTrials.gov