NCT00363883

Vorinostat in Treating Patients With Locally Recurrent or Metastatic Cancer of the Urothelium

Phase II Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Recurrent or Metastatic Transitional Cell Carcinoma of the Urothelium

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well vorinostat works in treating patients with locally recurrent or metastatic cancer of the urothelium.

Detailed description

PRIMARY OBJECTIVES: I. To determine response rate measured by RECIST criteria for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. SECONDARY OBJECTIVES: I. To determine the time to progression and overall survival for SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. II. To provide data on safety and toxicity of SAHA in patients with recurrent or metastatic transitional cell carcinoma of the urothelium. III. To obtain preliminary data on molecular correlates in tissue, oral mucosa and blood to determine feasibility and clinical efficacy. 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.

Conditions

• Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
• Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
• Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
• Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
• Transitional Cell Carcinoma of the Bladder

Interventions

Type	Name	Description
DRUG	vorinostat	Given orally
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2006-08-15
• Last updated: 2015-02-13
• Results posted: 2015-02-13

Locations

1 site across 1 country: United States