Lymphoma Clinical Trial
Official title:
VELCADE (Bortezomib) for Injection - Phase II Study of Bortezomib and Rituximab in Relapsed or Refractory 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.
OBJECTIVES:
Primary
- 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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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