A Phase II Study of Bortezomib (VELCADE®) in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
- 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
- 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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate after 2 courses of treatment
Lauren C. Pinter-Brown, MD
Jonsson Comprehensive Cancer Center
United States: Institutional Review Board
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|