Using Proton MRS to Predict Response of Vorinostat Treatment in Glioblastoma
I. To evaluate the strength of the association between magnetic resonance spectroscopy (MRS)
imaging measurable biomarkers and response to vorinostat plus temozolomide.
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).
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.
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
United States: Food and Drug Administration
|Emory University||Atlanta, Georgia 30322|