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

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00363883
Phase
PHASE2
Status
Terminated

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

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

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.

Key Dates

Start date
Jun 30, 2006
Status verified
Jan 2014
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: Treatment (vorinostat)
    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.

Primary Outcome Measure

Objective Tumor Response Rate [ Time Frame: Response assessed after every 2 cycles (6 weeks) up to 26 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Southern California, NorrisLos AngelesCalifornia90033-

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