Imatinib Mesylate Plus Cytarabine in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: cytarabine; imatinib mesylate
Intervention description: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle; Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months.
Intervention MeSH terms: Cytarabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: chronic phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by
      blocking the enzymes necessary for cancer cell growth.

      PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine to
      see how well it works in treating patients with chronic phase chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytogenetically confirmed chronic phase chronic myelogenous leukemia (CML)

               -  Less than 15% blasts in peripheral blood or bone marrow

               -  Less than 30% blasts and promyelocytes in peripheral blood or bone marrow

               -  Less than 20% basophils in blood or bone marrow

               -  Platelet count at least 100,000/mm^3

          -  Philadelphia chromosome positive

          -  No more than 6 months since initial diagnosis

          -  No presence of leukemia beyond the bone marrow, blood, liver, or spleen (i.e.,
             chloroma)

          -  Refused allogeneic stem cell transplantation as first-line therapy

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  See Disease Characteristics

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST or ALT no greater than 2 times ULN

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular:

          -  No New York Heart Association class III or IV heart disease

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for at least 3
             months after study participation

          -  No other serious uncontrolled medical condition

          -  No history of noncompliance to medical regimens or potential unreliability

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

          -  No prior biologic therapy for CML

        Chemotherapy:

          -  No prior chemotherapy for CML except hydroxyurea

          -  Concurrent hydroxyurea to control blood counts during first 3 months of treatment
             allowed

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  No prior endocrine therapy for CML

        Radiotherapy:

          -  No prior radiotherapy for CML

        Surgery:

          -  Not specified

        Other:

          -  More than 28 days since prior investigational anticancer agents

          -  Prior anagrelide hydrochloride for CML allowed

          -  Concurrent anagrelide hydrochloride to control blood counts during first 3 months of
             treatment allowed

          -  No concurrent grapefruit juice or grapefruit