Dose-Ranging Study of Arsenic Trioxide in Advanced Hematologic Cancers
OBJECTIVES: I. Develop a safe, weight-based, extended-dosing regimen of arsenic trioxide
suitable for outpatient therapy in patients with advanced hematologic cancers. II. Determine
the pattern of clinical adverse experience in patients treated with this drug. III. Evaluate
evidence of clinical responsiveness that may provide leads for further testing in patients
treated with this drug.
OUTLINE: This is a dose-escalation study. Patients receive arsenic trioxide IV over 1-4
hours on days 1-25. Courses repeat every 3-5 weeks in the absence of disease progression or
unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of arsenic trioxide
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at
which no more than 1 of 6 patients experiences dose-limiting toxicity. Patients are followed
for 1 month.
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|