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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082719
• Other study ID #: ID03-0172
• Secondary ID: P50CA091846P30CA
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2004
• Last updated: May 12, 2015
• Start date: December 2003
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urethral Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon	Data collection continues with treatment in absence of unacceptable toxicity.	2 Years	No

External Links

•   University of Texas MD Anderson Cancer Center Official Website