Phase II Study of Arsenic Trioxide, NSC 706363, in Relapsed of Refractory Chronic Myelogenous Leukemia
OBJECTIVES: I. Determine the antileukemic efficacy of arsenic trioxide in patients with
relapsed and/or refractory, chronic, accelerated, or blastic phase chronic myelogenous
leukemia. II. Determine the pattern of clinical adverse experience in this patient
population administered this drug.
OUTLINE: Patients are stratified according to disease stage (chronic phase vs accelerated
phase or blastic phase). Patients receive arsenic trioxide IV over 1 hour on consecutive
days or weekdays only for a total of 25 days followed by 3-5 weeks of rest. Treatment
continues for a maximum of 6 courses in the absence of unacceptable toxicity or disease
progression. Patients with responding disease are followed at least monthly.
PROJECTED ACCRUAL: A total of 10-27 patients will be accrued for the chronic phase stratum
of this study within 2 years. A total of 17-37 patients will be accrued for the accelerated
and blastic phases stratum of this study within 2 years.
Primary Purpose: Treatment
David A. Scheinberg, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|