Azacitidine in Treating Patients With Myelofibrosis

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed myelofibrosis with myeloid metaplasia (MMM), including any of the following subtypes:
• •* Agnogenic myeloid metaplasia
• •* Post-polycythemic myeloid metaplasia
• •* Post-thrombocythemic myeloid metaplasia
• •Evaluable and symptomatic disease, defined as 1 of the following:
• •* Anemia (hemoglobin \< 10 g/dL or erythrocyte transfusion-dependent, requiring 1 transfusion ≤ 8 weeks)
• •* Treatment required\* for symptomatic palpable splenomegaly (palpable hepatomegaly is acceptable if previously splenectomized) NOTE: \*Subjective but painful enough to mandate intervention
• •Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard cytogenetics (by peripheral blood or marrow)
• •\- Previous demonstration of a lack of this translocation (at any point) is sufficient
• •No advanced malignant hepatic tumors
• •PATIENT CHARACTERISTICS:
• •ECOG performance status 0-2
• •Absolute neutrophil count ≥ 1,000/mm³
• •Platelet count ≥ 50,000/mm³
• •Creatinine ≤ 2.0 mg/dL
• •Total bilirubin ≤ 2.0 mg/dL OR direct bilirubin ≤ 2.0 mg/dL if total bilirubin elevated (unless attributed to underlying disease)
• •AST and ALT ≤ 2 times upper limit of normal (unless clinically attributed to hepatic extramedullary hematopoiesis)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No baseline peripheral or autonomic neuropathy ≥ grade 2
• •No condition, including the presence of laboratory abnormalities, that would preclude study compliance
• •No hypersensitivity to mannitol or azacitidine
• •Not incarcerated in a municipality (i.e., county, state, or federal prison)
• •PRIOR CONCURRENT THERAPY:
• •At least 14 days since prior chemotherapy, including interferon alfa, anagrelide, or other myelosuppressive agents
• •At least 14 days since prior systemic corticosteroids
• •At least 14 days since prior investigational agents