Leukemia Clinical Trial
Official title:
Therapy of Advanced Stage Myelodysplastic Syndrome (MDS) With Arsenic Trioxide Given in Combination With Etanercept: A Phase I/II Study
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to
stop cancer cells from dividing so they stop growing or die. Biological therapies such as
etanercept may interfere with the growth of the cancer cells. Combining chemotherapy with
biological therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving arsenic trioxide
together with etanercept and to see how well it works in treating patients with
myelodysplastic syndromes.
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.
;
Primary Purpose: Treatment
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