Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium

Bladder Cancer Clinical Trial

Official title: Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon

Status Completed

Clinical Trial 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 works in treating patients with cancer of the urothelium.

Clinical Trial 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. Patients are randomized to 1 of 4 treatment arms.

In all arms, treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy.

• Arm I: Patients receive low-dose interferon alfa subcutaneously (SC) twice daily.

• Arm II: Patients receive interferon alfa as in arm I at a higher dose.

• Arm III: Patients receive interferon alfa SC once daily.

• Arm IV: Patients receive interferon alfa as in arm III at a higher dose. In all arms, treatment continues in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urethral Cancer
• Urinary Bladder Neoplasms

• NCT number: NCT00082719
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: December 2003
• Completion date: January 2015