Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045695
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2002-09-06
Brief Title:
Bortezomib in Treating Patients With Waldenstroms Macroglobulinemia
Sponsor:
NCIC Clinical Trials Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of PS-341 NSC 681239 In Patients With Untreated Or Relapsed Waldenstroms Macroglobulinemia
Status:
COMPLETED
Status Verified Date:
2011-09
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 Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstroms macroglobulinemia
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Determine the efficacy of bortezomib in terms of response rate in patients with previously untreated or relapsed Waldenstroms macroglobulinemia
Determine the toxicity of this drug in these patients
Determine the time to progression stable disease duration and response duration in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks Patients with complete or partial response or stable disease are followed every 3 months thereafter
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 15-2 years
Determine the efficacy of bortezomib in terms of response rate in patients with previously untreated or relapsed Waldenstroms macroglobulinemia
Determine the toxicity of this drug in these patients
Determine the time to progression stable disease duration and response duration in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks Patients with complete or partial response or stable disease are followed every 3 months thereafter
PROJECTED ACCRUAL A total of 15-25 patients will be accrued for this study within 15-2 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 |
|---|---|---|---|
| CDR0000257042 | OTHER | PDQ | None |
| CAN-NCIC-IND152 | None | None | None |
| ECOG-JI152 | None | None | None |
| NCI-NCIC-152 | None | None | None |