Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer
Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed renal cell carcinoma Advanced or metastatic disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan (phase II only) Failed ≥ 2 prior treatment regimens, including chemotherapy, immunotherapy (i.e., interleukin or interferon), biological agents (i.e., kinase inhibitors), or combinations thereof An overlap between classes of therapies given concurrently will be counted as 2 prior treatment regimens No known brain metastases ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% Life expectancy > 3 months WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 mg/dL AST and ALT < 2.5 times upper limit of normal Creatinine ≤ 2 mg/dL OR creatinine clearance > 50 mL/min Negative pregnancy test Exclusion criteria: Not pregnant or nursing No history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to vorinostat (SAHA), isotretinoin, or other agents or components (e.g., parabens) used in this study No uncontrolled intercurrent illness, including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness or social situation that would preclude study compliance No concurrent antiretroviral therapy for HIV-positive patients No other concurrent anticancer therapy, including radiation, biologic, or chemotherapeutic agents, for renal cell carcinoma or other tumors No other concurrent investigational agents, valproic acid, or other retinoid
Sites / Locations
- Montefiore Medical Center - Moses Campus
- Weill Medical College of Cornell University
Arms of the Study
Arm 1
Experimental
Treatment (vorinostat and isotretinoin)
Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.