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| Sponsor: | California Cancer Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | California Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00363883 |
Purpose
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 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2009 (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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| Tower Cancer Research Foundation | |
| Beverly Hills, California, United States, 90211 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| Veterans Affairs Outpatient Clinic - Martinez | |
| Martinez, California, United States, 94553 | |
| Contra Costa Regional Medical Center | |
| Martinez, California, United States, 94553 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Study Chair: | David I. Quinn, MD | USC/Norris Comprehensive Cancer Center |
More Information
| Responsible Party: | David R. Gandara, University of California Davis Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00363883 History of Changes |
| Other Study ID Numbers: | CDR0000491425, U01CA062505, CCC-PHII-61, NCI-6879 |
| Study First Received: | August 10, 2006 |
| Last Updated: | October 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
transitional cell carcinoma of the bladder recurrent bladder cancer recurrent transitional cell cancer of the renal pelvis and ureter metastatic transitional cell cancer of the renal pelvis and ureter stage IV bladder cancer |
recurrent urethral cancer urethral cancer associated with invasive bladder cancer anterior urethral cancer posterior urethral cancer |
|
Urinary Bladder Neoplasms Carcinoma, Transitional Cell Urethral Neoplasms Kidney Neoplasms Ureteral Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urethral Diseases Kidney Diseases Ureteral Diseases Vorinostat Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |