Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
- Determine the frequency of hematologic response in patients with intermediate-2 or
high-risk myelodysplastic syndromes (MDS) treated with arsenic trioxide and etanercept.
- Determine the efficacy of this regimen in patients with intermediate-1 or low-risk MDS
that was refractory to anti-thymocyte globulin and etanercept on protocol FHCRC-1872.
- Correlate results of ex vivo and in vitro studies of phenotypic, cytogenetic, and
functional disease characteristics with in vivo treatment response in patients treated
with this regimen.
- Determine parameters that are associated with a high probability of disease response in
patients treated with this regimen.
OUTLINE: This is a pilot study.
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 of week 1 and then twice
weekly on weeks 2-12 during course 1 (twice weekly on weeks 1-12 during course 2). Patients
also receive etanercept subcutaneously twice weekly during weeks 1, 2, 5, 6, 9, and 10.
Treatment repeats every 12 weeks for 2 courses in the absence of disease progression or
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18
Primary Purpose: Treatment
Hematologic response in patients with intermediate-2 or high-risk myelodysplastic syndromes
Bart L. Scott, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|