Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030875
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2002-02-14
Brief Title:
Bortezomib in Treating Patients With Mantle Cell Lymphoma
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase II Study Of PS-341 NSC 681239 In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2020-04
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 cells by blocking the enzymes necessary for cancer cell growth
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma
PURPOSE Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma
Detailed Description:
OBJECTIVES
Determine the efficacy of bortezomib in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma
Determine the toxicity of this drug in these patients
Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients
Determine the time to progression and response duration in patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive 2 courses beyond documentation of CR Patients with stable disease receive a maximum of 4 courses Patients with partial response PR continue therapy until disease progression or for 2 courses beyond documentation of stable PR
Patients are followed at 4 weeks and then every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 18-24 months
Determine the efficacy of bortezomib in terms of response rate in patients with previously untreated or relapsed mantle cell lymphoma
Determine the toxicity of this drug in these patients
Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients
Determine the time to progression and response duration in patients treated with this drug
OUTLINE This is a nonrandomized multicenter study
Patients receive bortezomib IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with complete response CR receive 2 courses beyond documentation of CR Patients with stable disease receive a maximum of 4 courses Patients with partial response PR continue therapy until disease progression or for 2 courses beyond documentation of stable PR
Patients are followed at 4 weeks and then every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 18-24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069207 | OTHER | PDQ | None |
| CAN-NCIC-IND150 | OTHER | None | None |