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A National Phase II Trial of Intron (Interferon-alfa 2b) Plus BCG for Treatment of Superficial Bladder Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

A National Phase II Trial of Intron (Interferon-alfa 2b) Plus BCG for Treatment of Superficial Bladder Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David A. Corral, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Triangle Urological Group

Authority:

United States: Federal Government

Study ID:

CDR0000067348

NCT ID:

NCT00004122

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263