Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Acute Myeloid Leukemia, Secondary Leukemia, and/or Newly-Diagnosed Patients Greater Than or Equal to 65 Years Old
OBJECTIVES: I. Determine the rate of response (complete or partial remission), duration of
response, relapse free survival, and overall survival of patients with relapsed or
refractory acute myeloid leukemia (AML) or untreated older patients or those with secondary
AML when treated with arsenic trioxide. II. Evaluate the toxicities of this agent in this
patient population. III. Measure degree of apoptosis induced and/or differentiation in
pretreatment and posttreatment AML cells.
OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours daily for up to 60 days, or
until bone marrow blasts are less than 5%, followed by 4-6 weeks of rest. After the first
course, additional courses of arsenic trioxide last 25 days. Treatment continues for a
maximum of 6 courses in the absence of unacceptable toxicity or disease progression.
Patients with a complete response (CR) receive 1 additional 25 day course after achieving
CR. 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.
Primary Purpose: Treatment
Martin S. Tallman, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|