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 diffuse large B-cell lymphoma that is refractory to previous chemotherapy.
OBJECTIVES: * Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib. * Determine the safety and tolerability of this drug in these patients. * Determine the time to disease progression in patients treated with this drug. * Determine the possible mechanism of resistance to this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 20 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Overall response rate (combined complete response and partial response)
Safety
Tolerability
Time to disease progression
Possible mechanism of resistance
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