Azacitidine in Treating Patients With Myelofibrosis

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine

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