Phase II Study of Arsenic Trioxide (NSC #706363) in Relapsed and Refractory Intermediate and High-Grade Non-Hodgkin's Lymphoma
OBJECTIVES: I. Determine the complete and partial response rates, duration of complete
response, freedom from progression, event free survival, and overall survival in patients
with relapsed or refractory intermediate or high grade lymphoma treated with arsenic
trioxide. II. Determine the toxicity of this regimen in these patients.
OUTLINE: Patients receive arsenic trioxide IV over 2-4 hours for a maximum of 25 cumulative
days followed by a rest period of 3-4 weeks. Patients with complete or partial response may
receive 6 additional courses in the absence of disease progression or unacceptable toxicity.
Patients with minor response (25-50% tumor regression) may also receive further courses of
treatment. Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 22-41 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
David J. Straus, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
99-051
NCT00005040
January 2000
July 2001
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |