Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

This phase I/II trial is studying the side effects and best dose of isotretinoin when given together with vorinostat and to see how well they work in treating patients with advanced kidney cancer. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Isotretinoin may cause kidney cancer cells to look more like normal cells, and to grow and spread more slowly. Giving vorinostat together with isotretinoin may kill more tumor cells.

Key facts

Study ID

NCT00324740

Run by

National Cancer Institute (NCI)

People needed

14

Starts

2006-03-01

Expected to finish

2014-05-01

Last updated by the study team

2021-02-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Weill Medical College of Cornell University — New York, New York, United States
• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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