Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
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-Hodgkin's 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-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.
|Lymphoma||Drug: bortezomib Drug: rituximab Procedure: antibody therapy Procedure: biological therapy Procedure: enzyme inhibitor therapy Procedure: monoclonal antibody therapy||Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory Non-Hodgkin's Lymphoma|
- Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma.
- Determine the overall response rate (partial response, complete response unconfirmed, and complete response) in these patients.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265928
|United States, Virginia|
|University of Virginia Cancer Center at UV Health System|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||John Densmore, MD||University of Virginia|