Recurrent Adult Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's
lymphoma using overall response rate as the primary efficacy endpoint.
II. To assess time to progression and 2-year overall survival after bortezomib therapy.
III. To evaluate the safety and tolerability of bortezomib in patients with
relapsed/refractory Hodgkin's lymphoma.
OUTLINE: This is a 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 rapid disease progression or
unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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