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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cancer and Leukemia Group B
Chicago, Illinois, United States
Start Date
March 1, 2004
Primary Completion Date
March 1, 2007
Last Updated
December 4, 2015
43
ACTUAL participants
17-N-allylamino-17-demethoxygeldanamycin/bortezomib
DRUG
Lead Sponsor
National Cancer Institute (NCI)
Data Source & Attribution
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