A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase
- Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in
patients with resistant chronic phase chronic myelogenous leukemia.
- Determine potential dose-limiting toxic effects in patients treated with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on
days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of
disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least
12 patients for phase II) will be accrued for this study .
Masking: Open Label, Primary Purpose: Treatment
Satey and Tolerability
Michael Mauro, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|H. Lee Moffitt Cancer Center||Tampa, Florida 33612|
|UCLA Department of Medicine, Division of Hematology/Oncology||Los Angeles, California 90095|