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

Phase 1

Completed

• Conditions: Urethral Cancer; Bladder Cancer
• Interventions: Biological: Recombinant Interferon Alfa

• Registration Number: NCT00082719
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-18
• Study First Posted: 2004-05-19
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-12
• Last Update Posted: 2015-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

1. 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.
2. Patients must understand the investigational nature of this study and provide written, informed consent.

Exclusion Criteria

1. Patients who are pregnant or lactating are not eligible. Women of child-bearing potential must have a negative pregnancy test before starting therapy.
2. Patients with current symptoms suggestive of clinically significant affective disorder.
3. Patients taking more than physiologic replacement doses of corticosteroids are not eligible.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm IV	Recombinant Interferon Alfa	Interferon alfa as in arm III at a higher dose.
Arm II	Recombinant Interferon Alfa	Interferon alfa as in arm I at a higher dose.
Arm III	Recombinant Interferon Alfa	Interferon alfa SC once daily.
Arm I	Recombinant Interferon Alfa	Low-dose interferon alfa subcutaneously (SC) twice daily.

Primary Outcome Measures

Name	Time	Method
Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon	2 Years	Data collection continues with treatment in absence of unacceptable toxicity.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States