Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265928
Status:
TERMINATED
Last Update Posted:
2008-01-28
First Post:
2005-12-14
Brief Title:
Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma
Sponsor:
University of Virginia
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
VELCADE Bortezomib for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkins Lymphoma
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn for poor accrual
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 some of the enzymes needed for cell growth Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma including Waldenstroms macroglobulinemia
PURPOSE This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkins lymphoma including Waldenstroms macroglobulinemia
Detailed Description:
OBJECTIVES
Primary
Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine the overall response rate partial response complete response unconfirmed and complete response in these patients
Secondary
Estimate the duration of response in patients treated with this regimen
Estimate the time to disease progression in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5 Treatment repeats every 5 weeks for 2 courses Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone
NOTE Patients receive rituximab in weeks 1-3 only during course 2 of treatment
After completion of study treatment patients are followed periodically for at least 18 months
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Primary
Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory B-cell non-Hodgkins lymphoma
Determine the overall response rate partial response complete response unconfirmed and complete response in these patients
Secondary
Estimate the duration of response in patients treated with this regimen
Estimate the time to disease progression in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive bortezomib IV over 3-5 seconds once weekly in weeks 1-4 and rituximab IV over 5-6 hours once weekly in weeks 1-5 Treatment repeats every 5 weeks for 2 courses Patients achieving stable disease or better receive an additional 4 courses of bortezomib alone
NOTE Patients receive rituximab in weeks 1-3 only during course 2 of treatment
After completion of study treatment patients are followed periodically for at least 18 months
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MILLENNIUM-LYMPHOMA2 | None | None | None |
| UVACC-HIC-12077 | None | None | None |
| UVACC-PRC-36805 | None | None | None |
| MILLENNIUM-X05181 | None | None | None |