Previously Treated Myelodysplastic Syndromes Clinical Trial
Official title:
Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
PRIMARY OBJECTIVES:
I. Determine the frequency of hematologic responses in patients with MDS to 5-aza
(azacitidine) plus etanercept.
II. Determine the efficacy of 5-aza combined with etanercept in patients with low or
intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus
etanercept and for the purpose of this trial are considered as having progressive or "more
advanced" disease.
III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional
disease characteristics with in vivo treatment responses, to identify parameters that are
associated with a high probability of response.
OUTLINE:
Patients receive etanercept subcutaneously (SC) twice weekly during weeks 1 and 2 and
azacitidine SC or intravenously (IV) over 10-40 minutes on days 1-7. Treatment repeats every
28 days for at least 3 courses. Treatment continues in the absence of disease progression or
unacceptable toxicity.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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