This phase II trial is studying how well vorinostat works in treating patients with advanced kidney cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. Determine the antitumor activity of vorinostat (SAHA), in terms of objective response and progression rate, in patients with advanced renal cell carcinoma. SECONDARY OBJECTIVES: I. Evaluate the safety and tolerability of this drug, in terms of toxicity profile, in these patients. II. Evaluate overall survival, progression-free survival, and survival rate at 12 months in patients treated with this drug. III. Correlate changes in biologic measurements with outcomes of patients treated with this drug. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Given orally
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
San Antonio, Texas, United States
Institute for Drug Development
San Antonio, Texas, United States
Objective Response
Objective response is measured using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST criteria. Complete Response (CR) - Disappearance of all target lesions, Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Progressive Disease (PD) - At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, Stable Disease (SD) - Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time frame: 1 year
Progression-free Survival
Time frame: 1 year
Overall Survival (OS) and Median OS
Time frame: 1 year
Safety and Tolerability
Time frame: 1 year
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