Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00066508|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : January 8, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: bortezomib||Phase 2|
- 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 (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||July 2005|
- Overall response rate (combined complete response and partial response)
- Time to disease progression
- Possible mechanism of resistance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066508
|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|