/NCT02137759

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

Trial number:: NCT02137759

Trial phase:: 2

Study type:: Local/Regional therapies, Chemotherapy, Supportive interventions, Observational

Overall status:: Active, not recruiting

Study start date

May, 2014

Scientific 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)

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.

- Newly-diagnosed glioblastoma or gliosarcoma that has been confirmed pathologically

- ≥ 18 years of age

- Able to have MRI scans

- Measurable contrast-enhancing supratentorial tumor (≥ 0.2 cc (current resolution of MRSI is 0.108cc)) in a region amenable to MRSI

- Have the following lab values ≤ 14 days prior to registration:

- white blood cell count ≥ 3,000/μL

- absolute neutrophil count ≥ 1,500/μL

- platelet count of ≥ 100,000/μL

- hemoglobin ≥ 10 gm/dL (transfusion is allowed to reach minimum level)

- serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2.0x upper normal limit (UNL)

- bilirubin ≤ 2 x UNL

- creatinine ≤ 1.5 mg/dL

- Life expectancy of ≥ 12 weeks

- Karnofsky Performance Score ≥ 60

- Women of childbearing potential must have a negative beta-human chorionic gonadotropin pregnancy test documented ≤ 7 days prior to registration

- All men and women of childbearing potential must agree to use adequate barrier contraception for the duration of study participation and for 12 weeks after the last dose of study drug (If pregnancy or suspected pregnancy occur while participating in study, treating physician should be informed immediately)

- Understand and provide written informed consent

- Both men and women, and members of all races and ethnic groups are eligible for this trial (Subjects will be approximately representative of the demographics of the referral base for the participating institutions)

- Able to swallow capsules

- Willing to provide mandatory tissue samples (unstained slides) for research purposes

- Willing to forego other cytotoxic and non-cytotoxic therapies against the tumor while being treated on this protocol

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Glioblastoma Multiforme of Brain

Choose trial site (2)

Emory University/Winship Cancer Institute

1365 Clifton Rd, Atlanta, GA 30322, USA

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

401 N Broadway, Baltimore, MD 21231, USA