Trials / Completed
CompletedNCT00030875
Bortezomib in Treating Patients With Mantle Cell Lymphoma
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- NCIC Clinical Trials Group · Network
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bortezomib |
Timeline
- Start date
- 2002-11-19
- Primary completion
- 2005-07-21
- Completion
- 2009-12-21
- First posted
- 2003-01-27
- Last updated
- 2023-08-04
Locations
10 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00030875. Inclusion in this directory is not an endorsement.