Vorinostat in Treating Patients With Kidney Cancer

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma that is either metastatic or inoperable
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy OR new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 based treatment
• Patients who have failed up to 4 lines of prior immunotherapy or biological therapy allowed
• No known brain metastases or leptomeningeal disease
• Stable brain metastases or curatively resected brain metastases without neurologic dysfunction for ≥ 6 months allowed
• ECOG performance status 0-2 OR Karnofsky 70-100%
• Life expectancy ≥ 12 weeks
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 50 mL/min
• Total bilirubin within normal limits
• AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
• No history of active malignancy (other than renal cell carcinoma) within the past 3 years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ cervical cancer
• No history of allergic reactions to compounds of similar chemical or biological composition to vorinostat (SAHA)
• No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
• No psychiatric illness or social situation that would preclude study compliance
• No clinically significant hypercalcemia
• No significant traumatic injury within the past 21 days
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No gastrointestinal disease resulting in an inability to take oral medication
• No requirement for IV alimentation
• No active peptic ulcer disease
• Recovered from prior therapy
• Prior nephrectomy or resection of metastatic lesions allowed provided full surgical recovery has occurred
• No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)
• No radiotherapy within the past 4 weeks
• No valproic acid for at least 2 weeks prior to study enrollment
• No prior surgical procedures affecting absorption
• No major surgery within the past 21 days
• No concurrent antiretroviral therapy for HIV-positive patients
• No other concurrent investigational agents
• No other concurrent anticancer therapy