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A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Start Date
May 1, 2003
Primary Completion Date
July 1, 2005
Last Updated
January 8, 2013
7
ACTUAL participants
bortezomib
DRUG
Lead Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
NCT06263491
NCT07388563
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT05529069