Clinical Trials Directory

Trials / Terminated

TerminatedNCT00324740

Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

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

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
14 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
21 Years
Healthy volunteers
Not accepted

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. 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.

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) II. Define dose-limiting and other toxicities in patients treated with this regimen. (Phase I) III. Determine the objective response rate of patients treated with this regimen. (Phase II) SECONDARY OBJECTIVES: I. Conduct a pharmacokinetic analysis of this regimen in these patients. (Phase I) II. Conduct gene profiling analysis of pre-study, paraffin-embedded tissues from patients treated with this regimen. (Phase I) III. Conduct correlative studies to identify the effect of SAHA and isotretinoin on RAR-B, LRAT, and STAT1-3 expression. (Phase I) OUTLINE: This is a multicenter, phase I, dose-escalation study of isotretinoin, followed by a multicenter, phase II, prospective, non-randomized study. Phase I: 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. 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. Phase II: Patients receive SAHA as in phase I and isotretinoin as in phase I at the MTD determined in phase I. 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.

Conditions

Interventions

TypeNameDescription
DRUGvorinostatGiven orally
DRUGisotretinoinGiven orally

Timeline

Start date
2006-03-01
Primary completion
2011-02-01
Completion
2014-05-01
First posted
2006-05-11
Last updated
2021-02-23
Results posted
2015-11-24

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00324740. Inclusion in this directory is not an endorsement.