Status:
TERMINATED
Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
PHASE2
Brief Summary
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. Vor...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose and phase II dose of isotretinoin when given in combination with vorinostat (SAHA) in patients with advanced renal cell carcinoma. (Phase I...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00324740
Start Date
March 1 2006
End Date
May 1 2014
Last Update
February 23 2021
Active Locations (2)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10065
2
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467-2490