Vorinostat in Treating Patients With Kidney Cancer
Recurrent Renal Cell Carcinoma, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- Institute for Drug Development
Arms of the Study
Arm 1
Experimental
Arm I
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.