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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 1

Conditions: Bladder Cancer; Urethral Cancer

Treatments: Biological: Recombinant Interferon Alfa

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00082719

P30CA016672 (U.S. NIH Grant/Contract)

P50CA091846 (U.S. NIH Grant/Contract)

NCI-2012-02015 (Registry Identifier)

ID03-0172

CDR0000355831 (Registry Identifier)

MDA-ID-030172 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Arm I

Experimental group

Description:

Low-dose interferon alfa subcutaneously (SC) twice daily.

Treatment:

Biological: Recombinant Interferon Alfa

Arm II

Experimental group

Description:

Interferon alfa as in arm I at a higher dose.

Treatment:

Biological: Recombinant Interferon Alfa

Arm III

Experimental group

Description:

Interferon alfa SC once daily.

Treatment:

Biological: Recombinant Interferon Alfa

Arm IV

Experimental group

Description:

Interferon alfa as in arm III at a higher dose.

Treatment:

Biological: Recombinant Interferon Alfa