Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003110
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Brief Title:
Bleomycin in Treating Patients With Non-Hodgkins Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Trial of 72-Hour Continuous Infusion Bleomycin as Salvage Therapy in AIDS-Related and Immunocompetent Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-06
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of bleomycin in treating patients with non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the objective response rate response duration and survival of patients receiving bleomycin as salvage therapy for AIDS-related or immunocompetent non-Hodgkins lymphoma II Assess the feasibility and toxicity of treatment for this disease III Evaluate the quality of life of AIDS and non-AIDS patients with non-Hodgkins lymphoma
OUTLINE Patients are stratified by number of prior cytotoxic chemotherapy regimens prior radiotherapy and HIVAIDS status Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks Induction therapy consists of 3 cycles Patients who achieve complete remission receive 2 more cycles Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs Quality of life assessments are conducted at beginning of therapy every 3 weeks and at completion of treatment Patients are followed every 3 months for overall survival
PROJECTED ACCRUAL A total of 32 patients will be accrued
OUTLINE Patients are stratified by number of prior cytotoxic chemotherapy regimens prior radiotherapy and HIVAIDS status Patients receive bleomycin by continuous infusion for 72 hours every 3 weeks Induction therapy consists of 3 cycles Patients who achieve complete remission receive 2 more cycles Patients with partial remission or stable disease may continue therapy until disease progression or unacceptable toxicity occurs Quality of life assessments are conducted at beginning of therapy every 3 weeks and at completion of treatment Patients are followed every 3 months for overall survival
PROJECTED ACCRUAL A total of 32 patients will be accrued
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-G97-1343 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-5496 | OTHER | None | None |
| AMC-7A-94 | None | None | None |
| BMS-CWRU-5496 | None | None | None |