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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00082719

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

133

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Urethral Cancer	Biological: Recombinant Interferon Alfa	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2003

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Low-dose interferon alfa subcutaneously (SC) twice daily.	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. Other Names: Interferon Alfa 2b Intron A
Experimental: Arm II Interferon alfa as in arm I at a higher dose.	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. Other Names: Interferon Alfa 2b Intron A
Experimental: Arm III Interferon alfa SC once daily.	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. Other Names: Interferon Alfa 2b Intron A
Experimental: Arm IV Interferon alfa as in arm III at a higher dose.	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. Other Names: Interferon Alfa 2b Intron A

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.