Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004072
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-12-10
Brief Title:
O6-benzylguanine And Carmustine in Treating Patients With Multiple Myeloma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of O6-Benzylguanine NSC 637037 and BCNU in Patients With Multiple Myeloma
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining O6-benzylguanine with carmustine in treating patients who have previously untreated refractory or relapsing multiple myeloma
PURPOSE Phase II trial to study the effectiveness of combining O6-benzylguanine with carmustine in treating patients who have previously untreated refractory or relapsing multiple myeloma
Detailed Description:
OBJECTIVES
Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma
Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient population
OUTLINE Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Patients receive 2 additional courses beyond attainment of best response partial or complete response or stable or plateau disease
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Evaluate the efficacy of O6-benzylguanine combined with carmustine in patients with previously untreated or refractory multiple myeloma
Assess the effects of O6-benzylguanine on bone marrow myeloma cells in this patient population
OUTLINE Patients receive O6-benzylguanine IV over 60 minutes followed 1 hour later by carmustine IV over 60 minutes Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Patients receive 2 additional courses beyond attainment of best response partial or complete response or stable or plateau disease
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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-T97-0021 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| U01CA062502 | NIH | None | None |
| P30CA043703 | NIH | None | None |
| CWRU-1A96 | OTHER | None | None |