Using Proton MRS to Predict Response of Vorinostat Treatment in Glioblastoma
PRIMARY OBJECTIVES:
I. To evaluate the strength of the association between magnetic resonance spectroscopy (MRS)
imaging measurable biomarkers and response to vorinostat plus temozolomide.
SECONDARY OBJECTIVES:
I. To evaluate MRS-detected inositol and N-acetylaspartate (NAA) levels (at 3 tesla) as
indicators of mood alterations as measured by a self-report depression survey (IDS-SR).
OUTLINE:
Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only)
and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity. Patients previously treated
with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.
Treatment repeats every 28 days in the absence of disease progression or unacceptable
toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at
approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression
Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Proportion of patients with MRS response to initial vorinostat by MRI and MRS scans
8 weeks
No
Jeffrey Olson
Principal Investigator
Emory University
United States: Food and Drug Administration
NCI-2011-02569
NCT01342757
December 2010
Name | Location |
---|---|
Emory University | Atlanta, Georgia 30322 |