Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)|
- Overall response rate (combined complete response and partial response) [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
- Tolerability [ Designated as safety issue: Yes ]
- Time to disease progression [ Designated as safety issue: No ]
- Possible mechanism of resistance [ Designated as safety issue: No ]
|Study Start Date:||May 2003|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095|
|Study Chair:||Sven De Vos, MD||Jonsson Comprehensive Cancer Center|