A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
- 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
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
Allocation: Non-Randomized, Primary Purpose: Treatment
Andrew R. Belch, MD
Cross Cancer Institute at University of Alberta
United States: Federal Government