Spots Global Cancer Trial Database for Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

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Trial Identification

Brief Title: Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

Official Title: Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.

Study ID: NCT00118287

Conditions

de Novo Myelodysplastic Syndromes

Previously Treated Myelodysplastic Syndromes

Secondary Myelodysplastic Syndromes

Interventions

azacitidine

etanercept

Study Description

Brief Summary: 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

Detailed Description: 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.