Lymphoma Clinical Trial
Official title:
A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
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.
OBJECTIVES:
- 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.
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