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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00363883 |
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.
Condition | Intervention | Phase |
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: vorinostat Procedure: gene expression profiling Procedure: immunohistochemistry staining method |
Phase II |
Genetics Home Reference related topics: | bladder cancer |
MedlinePlus related topics: | Bladder Cancer Cancer |
ChemIDplus related topics: | Suberoylanilide hydroxamic acid |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Recurrent or Metastatic Transitional Cell Carcinoma of the Urethelium |
Estimated Enrollment: | 37 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and buccal mucosa collection and tumor biopsies (if accessible) at baseline and periodically during study for correlative studies. Samples are examined by gene expression profiling and immunohistochemistry.
After completion of study treatment, patients are followed for up to 26 weeks.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathological diagnosis of transitional cell carcinoma of the bladder or other sites of the urothelium
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
PATIENT CHARACTERISTICS:
No allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat (SAHA), including any of the following:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, California | |||||
City of Hope Comprehensive Cancer Center | |||||
Duarte, California, United States, 91010-3000 | |||||
City of Hope Medical Group | |||||
Pasadena, California, United States, 91105 | |||||
Contra Costa Regional Medical Center | |||||
Martinez, California, United States, 94553 | |||||
Tower Cancer Research Foundation | |||||
Beverly Hills, California, United States, 90211 | |||||
University of California Davis Cancer Center | |||||
Sacramento, California, United States, 95817 | |||||
USC/Norris Comprehensive Cancer Center and Hospital | |||||
Los Angeles, California, United States, 90033-0804 | |||||
Veterans Affairs Outpatient Clinic - Martinez | |||||
Martinez, California, United States, 94553 | |||||
United States, Pennsylvania | |||||
UPMC Cancer Centers | |||||
Pittsburgh, Pennsylvania, United States, 15232 |
California Cancer Consortium |
National Cancer Institute (NCI) |
Study Chair: | David I. Quinn, MD | Norris Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Cheung EM, Quinn DI, Tsao-Wei DD, et al.: Phase II study of vorinostat (Suberoylanilide Hydroxamic Acid, SAHA) in patients with advanced transitional cell urothelial cancer (TCC) after platinum-based therapy--California Cancer Consortium/University of Pittsburgh NCI/CTEP-sponsored trial. [Abstract] J Clin Oncol 26 (Suppl 15): A-16058.
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Study ID Numbers: | CDR0000491425, CCC-PHII-61, NCI-6879 |
First Received: | August 10, 2006 |
Last Updated: | September 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00363883 |
Health Authority: | United States: Food and Drug Administration |
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