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

Primary Purpose

Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BCG vaccine
recombinant interferon alfa
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven transitional cell carcinoma of the bladder No muscle invasive bladder cancer, transitional cell carcinoma of the upper tract, or disease within the prostatic stroma No prior evidence of metastatic transitional cell carcinoma Prior definitive resection by partial cystectomy, nephroureterectomy, or prostatectomy allowed if current disease is limited to superficial disease of the bladder only No evidence of gross hematuria within the past 2 days PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other active malignancies or health conditions that would preclude study No serious infection within 1 month of study No evidence of active tuberculosis No significant medical or psychiatric condition that would prevent compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior intravesical interferon alfa and/or BCG At least 2 years since prior immunotherapy for other malignancies or nonmalignancies Chemotherapy: At least 4 weeks since prior intravesical chemotherapy At least 2 years since prior chemotherapy for other malignancies or nonmalignancies No concurrent cytotoxic chemotherapy for other malignancies or nonmalignancies Endocrine therapy: Not specified Radiotherapy: At least 2 years since prior pelvic radiotherapy for other malignancies or nonmalignancies No concurrent pelvic radiotherapy for other malignancies or nonmalignancies Surgery: See Disease Characteristics At least 3 weeks since prior papillary or solid transitional cell carcinoma resection, bladder biopsy, or transurethral resection of the prostate At least 4 weeks since prior surgery Other: At least 2 years since any prior cytotoxic agents for other malignancies or nonmalignancies

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
January 31, 2013
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004122
Brief Title
BCG Plus Interferon Alfa 2b in Treating Patients With Bladder Cancer
Official Title
A National Phase II Trial of Intron (Interferon-alfa 2b) Plus BCG for Treatment of Superficial Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
April 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage I bladder cancer, recurrent bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
BCG vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven transitional cell carcinoma of the bladder No muscle invasive bladder cancer, transitional cell carcinoma of the upper tract, or disease within the prostatic stroma No prior evidence of metastatic transitional cell carcinoma Prior definitive resection by partial cystectomy, nephroureterectomy, or prostatectomy allowed if current disease is limited to superficial disease of the bladder only No evidence of gross hematuria within the past 2 days PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other active malignancies or health conditions that would preclude study No serious infection within 1 month of study No evidence of active tuberculosis No significant medical or psychiatric condition that would prevent compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior intravesical interferon alfa and/or BCG At least 2 years since prior immunotherapy for other malignancies or nonmalignancies Chemotherapy: At least 4 weeks since prior intravesical chemotherapy At least 2 years since prior chemotherapy for other malignancies or nonmalignancies No concurrent cytotoxic chemotherapy for other malignancies or nonmalignancies Endocrine therapy: Not specified Radiotherapy: At least 2 years since prior pelvic radiotherapy for other malignancies or nonmalignancies No concurrent pelvic radiotherapy for other malignancies or nonmalignancies Surgery: See Disease Characteristics At least 3 weeks since prior papillary or solid transitional cell carcinoma resection, bladder biopsy, or transurethral resection of the prostate At least 4 weeks since prior surgery Other: At least 2 years since any prior cytotoxic agents for other malignancies or nonmalignancies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Corral, MD
Organizational Affiliation
Triangle Urological Group
Official's Role
Study Chair
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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