Phase I Study of Arsenic Trioxide
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of arsenic trioxide in adult and
pediatric patients with advanced solid tumors. II. Determine the pattern of clinical adverse
experience of arsenic trioxide in this patient population. III. Evaluate evidence of
clinical responsiveness to this treatment regimen.
OUTLINE: This is a dose escalation, open label study. Patients are stratified by age
(pediatric vs adult). Patients receive arsenic trioxide IV over 1-2 hours once daily for 3
consecutive days then once weekly for 5 weeks. Patients with stable or responding disease
receive additional courses of therapy every 8 weeks for up to 1 year in the absence of
disease progression or unacceptable toxicity. Patients receive escalating doses of arsenic
trioxide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 or more patients out of 6 experience dose limiting toxicity.
Patients are followed for at least 1 month after treatment.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Primary Purpose: Treatment
Steven Soignet, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|