A Phase II, Pharmacokinetic and Biologic Correlative Study of Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Advanced Renal Cell Carcinoma (RCC)
- Determine the antitumor activity of vorinostat (SAHA), in terms of objective response
and progression rate, in patients with advanced renal cell carcinoma.
- Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in
- Evaluate overall survival, progression-free survival, and survival rate at 12 months in
patients treated with this drug.
- Correlate changes in biologic measurements with outcomes of patients treated with this
OUTLINE: This is an open-label, multicenter study.
Patients receive oral vorinostat (SAHA) twice daily on days 1-3, 8-10, 15-17, and 22-24.
Courses repeat every 28 days for up to 52 weeks in the absence of disease progression or
unacceptable toxicity. Patients may have the option of continuing treatment beyond 52 weeks
at the discretion of the investigator.
After completion of study treatment, patients are followed within 1 month and then
approximately every 2 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
John Sarantopoulos, MD
Cancer Therapy and Research Center, Texas
United States: Food and Drug Administration
|Brooke Army Medical Center||Fort Sam Houston, Texas 78234-6200|
|Veterans Affairs Medical Center - San Antonio (Murphy)||San Antonio, Texas 78284|
|Cancer Therapy and Research Center||San Antonio, Texas 78229|
|Institute for Drug Development||San Antonio, Texas 78245-3217|