Phase II Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Recurrent Glioblastoma
I. Determine the efficacy of vorinostat (SAHA), in terms of 6-month progression-free
survival, in patients with progressive or recurrent glioblastoma multiforme.
II. Determine the safety and toxicity of this drug in these patients.
I. Determine the pharmacokinetics of this drug in these patients. II. Determine the biologic
effect of this drug in target tissues, including primary tumor tissue, in these patients.
III. Correlate genetic alteration of tumors with response in patients treated with this
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to
planned surgery (yes [stratum 1] vs no [stratum 2]) and number of prior chemotherapy
regimens for progressive/recurrent disease (≤ 1 [stratum 1A] vs ≥ 2 [stratum 1B]).
STRATUM 1: Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat
every 3 weeks in the absence of disease progression or unacceptable toxicity. (not
STRATUM 2: 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. (undergoing
Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimated and compared using Kaplan-Meier survival curves and logrank test.
From date of registration to date of progression or death due to any cause or last follow-up, assessed up to 5 years
North Central Cancer Treatment Group
United States: Food and Drug Administration
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