Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Inclusion Criteria:

• Histologically confirmed grade 4 astrocytoma (glioblastoma multiforme), including gliosarcoma, at primary diagnosis or recurrence

• Progressive or recurrent disease

• Measurable or evaluable disease by MRI or CT scan

• Performance status - ECOG 0-2

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 8 g/dL

• AST ≤ 3 times upper limit of normal (ULN)

• Bilirubin normal

• Creatinine ≤ 1.5 times ULN

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy

• No known HIV positivity

• Not immunocompromised except if related to the use of corticosteroids

• No known hypersensitivity to any of the components of the study drug

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No other malignancy

• No other severe disease that would preclude study participation

• Prior adjuvant chemotherapy allowed

• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)

• More than 2 weeks since prior small molecule cell cycle inhibitor

• Concurrent corticosteroids allowed as long as dose has been stable for ≥ 1 week

• At least 8 weeks since prior radiotherapy

• Must have evidence of tumor progression by MRI or CT scan after radiotherapy

• More than 6 weeks since prior stereotactic radiosurgery or interstitial brachytherapy, unless 1 of the following criteria is met:

• There is a separate lesion by MRI outside of the prior treatment field

• There is evidence of recurrent disease by biopsy, MRI spectroscopy, or positron-emission tomography scan

• More than 2 weeks since prior valproic acid