Status:
COMPLETED
Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Urethral Cancer
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer. PURPOSE: This randomized phase I trial is studying how well low-dose interferon alfa ...
Detailed Description
OBJECTIVES: * Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa. OUTLINE: This is a randomized study. ...
Eligibility Criteria
Inclusion
- Patients must have histologically proven urothelial cancer, known or suspected (e.g. by outside evaluation) to be muscle-invasive, and be scheduled for cystoscopy and transurethral biopsy as part of their routine evaluation at M. D. Anderson.
- Patients must understand the investigational nature of this study and provide written, informed consent.
Exclusion
- Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
- Patients with current symptoms suggestive of clinically significant affective disorder.
- Patients taking more than physiologic replacement doses of corticosteroids are not eligible.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00082719
Start Date
December 1 2003
End Date
January 1 2015
Last Update
May 14 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009