Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

About this trial
This is an interventional treatment trial for de Novo Myelodysplastic Syndromes
Eligibility Criteria
Inclusion Criteria: Int-2 or high risk MDS patients Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with: Single or multilineage cytopenia (absolute neutrophil count [ANC] < 1500/μL, hemoglobin [Hgb],10g/dL, or platelet count < 100,000/μL); or Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period Serum creatinine =< 1.5x ULN (upper limit of normal) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2x ULN Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5) Exclusion Criteria: Patients who have previously received hematopoietic stem cell transplants, specifically for MDS Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e >= 20% blasts) at time of enrollment Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study Men who are unwilling to use contraception while receiving 5-aza Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure Platelet count =< 10,000/mcl Absolute neutrophil count =< 250/mcl Prior treatment with 5-aza Known or suspected hypersensitivity to azacitidine or mannitol
Sites / Locations
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment (chemotherapy, chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or 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.