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| Sponsor: | Weill Medical College of Cornell University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00324740 |
Purpose
RATIONALE: 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.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: isotretinoin Drug: vorinostat Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis Other: pharmacological study Procedure: biopsy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in Combination With Isotretinoin (13-Cis Retinoic Acid, 13-CRA) in the Treatment of Patients With Advanced Renal Cell Carcinoma |
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of isotretinoin, followed by a multicenter, phase II, prospective, non-randomized study.
Cohorts of 3-6 patients receive escalating doses of isotretinoin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Tissue and blood samples are obtained for biomarker/laboratory studies in weeks 1 and 4. Gene profile analysis is conducted on tumor tissue.
After completion of study treatment, patients are followed for 12 weeks.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma
Failed ≥ 2 prior treatment regimens, including chemotherapy, immunotherapy (i.e., interleukin or interferon), biological agents (i.e., kinase inhibitors), or combinations thereof
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, New York | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Max W. Sung, MD 212-241-7902 max.sung@mssm.edu | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Anna C. Ferrari, MD 212-731-5389 anna.ferrari@nyumc.org | |
| Study Chair: | David M. Nanus, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Joseph A. Sparano, Albert Einstein Cancer Center at Albert Einstein College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00324740 History of Changes |
| Other Study ID Numbers: | CDR0000472916, NYWCCC-0511008257, NCI-6896 |
| Study First Received: | May 10, 2006 |
| Last Updated: | June 9, 2009 |
| Health Authority: | Unspecified |
|
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases |
Urologic Diseases Isotretinoin Vorinostat Dermatologic Agents Therapeutic Uses Pharmacologic Actions Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |