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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bladder Cancer; Urethral Cancer

Intervention: Recombinant Interferon Alfa (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Ashish M. Kamat, MD, Principal Investigator, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

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

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

Primary outcome: Descriptive Data on Expression of Death Effectors in Context of Low-dose Interferon

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Texas MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

University of Texas MD Anderson Cancer Center Official Website

Starting date: December 2003
Last updated: May 12, 2015

Page last updated: August 23, 2015

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