Vorinostat in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
About this trial
This is an interventional treatment trial for Adult Giant Cell Glioblastoma
Eligibility Criteria
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
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Stratum 1 (not undergoing surgery)
Stratum 2 (undergoing surgery)
Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Beginning 3 days prior to surgery, patients receive oral SAHA once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.