Arsenic Trioxide Alone or With ATRA (Vesanoid) for Resistant Hematologic Malignancy
This is a dose escalation and efficacy study of arsenic trioxide. In the efficacy study,
patients are stratified according to diagnosis (acute myelogenous leukemia vs acute
lymphocytic leukemia vs myelodysplastic syndrome vs multiple myeloma vs non-Hodgkin's
lymphoma and Hodgkin's disease). Phase I: Patients receive arsenic trioxide IV over 2 hours
daily for 28 days. Treatment repeats every 42-59 days in the absence of disease progression
or unacceptable toxicity. Patients who achieve complete remission (CR) or partial remission
(PR) receive up to 4 courses. Patients who fail to achieve CR or PR or who experience
disease progression may receive arsenic trioxide and tretinoin daily for 28 days every 42-59
days for up to 7 courses. Patients who fail to achieve CR or PR or experience disease
progression with arsenic trioxide and tretinoin are removed from study. Cohorts of 3-6
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 of 6 patients
experience dose limiting toxicities. Phase II: Patients receive the MTD of arsenic trioxide
as in phase I for up to 7 courses. Patients who fail to achieve CR or PR after 3 courses or
experience disease progression are either taken off study or treated with arsenic trioxide
and tretinoin as in phase I. Patients are followed monthly for 6 months, and then every 3
months for 18 months.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
28 days
Yes
Randy A. Brown, MD
Study Chair
Washington University Siteman Cancer Center
United States: Food and Drug Administration
CDR0000068108
NCT00006220
June 1999
February 2002
Name | Location |
---|---|
Washington University Barnard Cancer Center | Saint Louis, Missouri 63110 |