Imatinib Mesylate in Treating Patients With Myelofibrosis
Condition: Chronic Myeloproliferative Disorders
MeSH terms: Primary Myelofibrosis; Myeloproliferative Disorders
Intervention: imatinib mesylate
Intervention description: Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic idiopathic myelofibrosis; polycythemia vera; essential thrombocythemia

Summary:

      RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the
      enzymes needed for cell growth.

      PURPOSE: This phase II trial is studying the side effects of imatinib mesylate and how well
      it works in treating patients with myelofibrosis.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of myelofibrosis with myeloid metaplasia (MMM), defined by all of the
             following:

               -  Leukoerythroblastic blood picture

               -  Fibrosis involving > 1/3 sectional area of bone marrow biopsy

               -  Splenomegaly (unless patient has undergone prior splenectomy)

               -  Philadelphia chromosome negative

               -  No myelodysplastic syndrome

               -  No systemic disorders associated with marrow fibrosis

          -  Red blood cell transfusion dependent, defined by 1 of the following:

               -  Patient has required ≥ 2 units of red blood cells every 4 weeks within the past 8
                  weeks

               -  Hemoglobin ≤ 8 g/dL on ≥ 3 occasions (≥ 2 weeks apart ) over the past 8 weeks

          -  No evidence of disease transformation to acute myelogenous leukemia, defined as > 20%
             blasts in bone marrow and/or peripheral blood

        PATIENT CHARACTERISTICS:

        Performance status

          -  ECOG 0-3

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count > 1,000/mm^3

          -  Platelet count > 50,000/mm^3

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  AST or ALT ≤ 2 times ULN (unless due to extramedullary hematopoiesis in the liver)

        Renal

          -  Creatinine ≤ 1.5 times ULN

        Cardiovascular

          -  No New York Heart Association grade III-IV heart disease

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier method contraception during and for 3
             months after completion of study treatment

          -  No serious, uncontrolled medical condition

          -  No patients who are considered potentially unreliable or with a history of
             noncompliance to medical regimens

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  More than 2 weeks since prior interferon alfa

        Chemotherapy

          -  No concurrent chemotherapy except hydroxyurea to control elevated blood counts

        Endocrine therapy

          -  More than 4 weeks since prior corticosteroids, danazol, or other androgens for MMM

        Other

          -  More than 4 weeks since other prior treatment for MMM

          -  No other concurrent experimental drug therapy for MMM