NCT00082719

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Urethral Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Interferon Alfa	In all arms, treatment begins at pre-operative visit and continues until cystoscopy. Arm I: Low-dose interferon alfa subcutaneously (SC) twice daily. Arm II: Interferon alfa as in arm I at a higher dose. Arm III: Interferon alfa SC once daily. Arm IV: Interferon alfa as in arm III at a higher dose.

Timeline

• Start date: 2003-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2004-05-19
• Last updated: 2015-05-14

Locations

1 site across 1 country: United States