Low-Dose Decitabine in Treating Patients With Symptomatic Myelofibrosis
Condition: Chronic Myeloproliferative Disorders; Secondary Myelofibrosis
MeSH terms: Primary Myelofibrosis; Myeloproliferative Disorders
Intervention: Dacogen
Intervention MeSH terms: Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: primary myelofibrosis; secondary myelofibrosis; essential thrombocythemia; polycythemia vera

Summary:

      RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying the side effects and how well low-dose decitabine
      works in treating patients with symptomatic myelofibrosis.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histological confirmation of primary myelofibrosis or post essential thrombocythemic
             or polycythemic vera myelofibrosis

               -  Reticulin fibrosis ≥ grade 1

          -  Evaluable and symptomatic disease worthy of treatment, characterized by ≥ 1 of the
             following:

               -  Anemia, defined as hemoglobin < 11 g/dL or erythrocyte transfusion dependence

               -  Palpable and symptomatic splenomegaly (palpable and symptomatic hepatomegaly is
                  acceptable if previously splenectomized)

               -  Severe, disease-related constitutional symptoms, including ≥ 1 of the following:

                    -  Severe night sweats

                    -  Fevers

                    -  Weight loss

                    -  Bone pain

          -  Absence of t(9;22) by fluorescent in situ hybridization (FISH) or standard
             cytogenetics OR prior demonstration of a lack of this translocation

        PATIENT CHARACTERISTICS:

          -  Eastern Co-operative Oncology Group (ECOG) performance status 0-3

          -  Absolute neutrophil count (ANC) ≥ 1,000/mm³

          -  Platelet count ≥ 50,000/mm³

          -  Creatinine ≤ 2.0 mg/dL

          -  Direct or total bilirubin ≤ 2.0 mg/dL

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper
             limit of normal (ULN) (≤ 5 times ULN if elevation is attributed to hepatic
             extramedullary hematopoiesis)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Not incarcerated in a municipality, county, state, or federal prison

          -  No serious medical condition or psychiatric illness that would preclude signing the
             informed consent

          -  No condition that, in the opinion of the treating physician, places the patient at
             unacceptable risk for study participation or confounds the ability to interpret study
             data

          -  Able to adhere to the study visit schedule and other study requirements

        PRIOR CONCURRENT THERAPY:

          -  No other concurrent chemotherapy (e.g., hydroxyurea, thalidomide, interferon alpha,
             anagrelide, or other myelosuppressive agent) or experimental therapy