Spots Global Cancer Trial Database for Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium

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Trial Identification

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

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

Study ID: NCT00082719

Conditions

Bladder Cancer

Urethral Cancer

Interventions

Recombinant Interferon Alfa

Study Description

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 works in treating patients with cancer of the urothelium.

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. 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.