Multicenter Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Hodgkin's Disease
OBJECTIVES: I. Determine the efficacy of arsenic trioxide in terms of rate of response
(complete or partial remission), duration of response, relapse free survival, and overall
survival in patients with relapsed or refractory Hodgkin's disease. II. Evaluate the
toxicities of this agent in this patient population. III. Elucidate the mechanism of action
of this treatment by measuring induction of apoptosis and caspace activation when given to
these patients.
OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 1-2 hours
daily for up to 60 days. After 4-6 weeks of rest, patients receive up to 5 additional
courses of therapy of 25 days each followed by 4-6 weeks of rest. Patients with a complete
response (CR) receive 1 additional course of 25 days after achieving CR. Treatment continues
in the absence of unacceptable toxicity or disease progression. Patients are followed
monthly for 6 months, every 2 months for 6 months, every 3 months for 12 months, and then
every 6 months thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.
Interventional
Primary Purpose: Treatment
Martin S. Tallman, MD
Study Chair
Robert H. Lurie Cancer Center
United States: Federal Government
NCI 99H5
NCT00005595
June 2000
April 2002
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |