Bortezomib in Treating Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma
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|ClinicalTrials.gov Identifier: NCT00182637|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with relapsed or refractory cutaneous T-cell lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: bortezomib||Phase 2|
- Determine the response rates (complete response and partial response) and duration of response in patients with relapsed or refractory cutaneous T-cell lymphoma treated with bortezomib.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label 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.
After completion of study treatment, patients are followed at 1 month and then at least every 3 months for 2 years or until disease progression.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
|Experimental: bortezomib||Drug: bortezomib|
- Overall Response Rate After 2 Courses of Treatment [ Time Frame: 2 months ]
- Time to Progression [ Time Frame: 2 years ]
- Toxicity [ Time Frame: 2 years ]
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): NCT00182637
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Principal Investigator:||Lauren C. Pinter-Brown, MD||Jonsson Comprehensive Cancer Center|