Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004122
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-12-10
Brief Title:
BCG Plus Interferon Alfa 2b in Treating Patients With Bladder Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A National Phase II Trial of Intron Interferon-alfa 2b Plus BCG for Treatment of Superficial Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 15 years and then annually thereafter
PROJECTED ACCRUAL A total of 660 patients will be accrued for this study within 25 years
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 andor 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 15 years and then annually thereafter
PROJECTED ACCRUAL A total of 660 patients will be accrued for this study within 25 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G99-1605 | None | None | None |
| RPCI-DS-99-07 | None | None | None |