Finding studies
Finding studies
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Lead
Fred Hutchinson Cancer Center
With
OBJECTIVES: * 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 unacceptable toxicity. Patients are followed for 3 months. PROJECTED ACCRUAL: A total of 15-32 patients will be accrued for this study within 8-18 months.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
