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BCG Plus Interferon Alfa 2b in Treating Patients With Bladder Cancer

2014-08-27 03:58:21 | BioPortfolio

Summary

RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. Interferon alfa may interfere with the growth of cancer cells. Combining these therapies may be an effective treatment for bladder cancer.

PURPOSE: Phase II trial to study the effectiveness of BCG plus interferon alfa 2b in treating patients who have bladder cancer.

Description

OBJECTIVES: I. Compare the efficacy of BCG combined with interferon alfa 2b in patients with superficial bladder cancer. II. Determine the relative local and systemic toxicities of this regimen and its effect on quality of life in these patients. III. Evaluate the effect of BCG dose reduction during therapy on symptom tolerance and ability to maintain an extended treatment plan in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to prior BCG exposure and BCG tolerance (no prior BCG exposure vs prior BCG exposure, BCG tolerant vs prior BCG and interferon alfa treatment failure, BCG intolerant). Patients receive induction therapy consisting of varying strengths of BCG plus interferon alfa intravesically weekly for 6 weeks. Patients with disease recurrence which is resectable and/or amenable to intravesical therapy following the first induction course may receive an additional course of induction therapy. At 3 months, patients undergo evaluatory cystoscopy and cytology. At 4 months, patients with no evidence of disease receive varying strengths of maintenance therapy consisting of BCG and interferon alfa intravesically weekly for 3 weeks. Treatment repeats every 6 months for 3 courses. Quality of life is assessed within 1 week following the last induction and maintenance treatment and prior to cystoscopy. Patients are followed every 3 months for 6 months, every 6 months for 1.5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 660 patients will be accrued for this study within 2.5 years.

Study Design

Primary Purpose: Treatment

Conditions

Bladder Cancer

Intervention

BCG vaccine, recombinant interferon alfa

Location

Roswell Park Cancer Institute
Buffalo
New York
United States
14263-0001

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:21-0400

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Medical and Biotech [MESH] Definitions

A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.

A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

Tumors or cancer of the URINARY BLADDER.

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