Vorinostat and Isotretinoin in Treating Patients With Advanced Kidney Cancer

Part of paid clinical trials in New York, New York.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00324740
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Recurrent Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • vorinostat — DRUG
    Given orally
  • isotretinoin — DRUG
    Given orally

Study Details

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 Dates

Start date
Mar 31, 2006
Status verified
Feb 2021
Primary completion
Feb 28, 2011
Completion
May 31, 2014

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants With at Least One Dose Limiting Toxicity Associated With Vorinostat Concurrently Administered With Isotretinoin [ Time Frame: Course 1, up to 28 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Medical College of Cornell UniversityNew YorkNew York10065-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-2490-

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