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BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer Clinical research trials and BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer. BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer  BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
For Condition: stage 1 bladder cancer,Quality of Life,transitional cell carcinoma of the bladder,recurrent bladder cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Roswell Park Cancer Institute
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidCorral, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000067348; RPCI-DS-99-07,NCI-G99-1605
Study Start Date: July 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004122
Other Stage 1 Bladder Cancer Studies:
1. Radiation Therapy With or Without Carbogen and Niacinamide in Treating Patients With Bladder Cancer
2. Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
3. BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
4. Transurethral Resection and Combination Chemotherapy in Treating Patients With Stage II or Stage III Bladder Cancer
5. Fenretinide to Prevent Cancer Recurrence in Treating Patients With Bladder Cancer
Related Studies:
Other stage 1 bladder cancer Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
BCG Plus Interferon alfa 2b in Treating Patients With Bladder Cancer
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