Suberoylanilide Hydroxamic Acid (SAHA), Bevacizumab, Daily Temozolomide for Recurrent Malignant Gliomas

This is a Phase I/II open-label, single-arm study among recurrent malignant glioma patients.
Patients will be treated with Vorinostat in combination with Bevacizumab (BV) (10 mg/kg) and
Temozolomide (T) (50 mg/m2/day) BV is administered every 2 weeks. Temozolomide will be taken
orally once every day. Vorinostat will be taken orally on days 1-7 and 15-21 of each 28-day
cycle. In the phase I portion of this study, the dose of Vorinostat will be escalated in
successive cohorts of patients to determine the maximum tolerated dose (MTD) and
dose-limiting toxicity (DLT). In the phase II portion of this study, the dose of Vorinostat
will be the MTD determined in the phase I portion. The primary endpoint of the phase II
study is 6-month progression-free survival (PFS) for recurrent GBM patients. This study will
be conducted at The Preston Robert Tisch Brain Tumor Center at Duke.