Imatinib Mesylate and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: recombinant interferon alfa; imatinib mesylate
Intervention description: IFN-α will be given at a dose ranging up to 5 MIU daily via subcutaneous injection.; Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
Intervention MeSH terms: Interferons; Interferon-alpha; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: relapsing chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; Philadelphia chromosome positive chronic myelogenous leukemia

Summary:

      RATIONALE: Imatinib mesylate and interferon alfa may interfere with the growth of the cancer
      cells. Combining imatinib mesylate with interferon alfa may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining imatinib mesylate with
      interferon alfa in treating patients who have chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Cytogenetically confirmed 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

          -  No leukemia beyond bone marrow, blood, liver, or spleen

          -  No chloroma

          -  Phase I (closed to accrual as of 7/9/03):

               -  Philadelphia (Ph) chromosome-positive CML in chronic phase

          -  Phase II:

               -  Newly diagnosed Ph chromosome-positive CML in chronic phase

               -  Initial diagnosis within 6 months of study

               -  No prior therapy for CML except hydroxyurea and/or anagrelide hydrochloride

          -  Phase I (closed to accrual as of 7/9/03) and II:

               -  No identified sibling donors where allogeneic stem cell transplantation is
                  elected as first-line therapy

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  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 2 methods of effective barrier contraception during and for
             at least 3 months after study participation

          -  No other serious uncontrolled medical condition

          -  No autoimmune disease

          -  No prior noncompliance to medical regimens or potential unreliability

          -  No prior grade 3 or greater non-hematologic toxicity due to prior interferon (phase I
             [closed to accrual as of 7/9/03])

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

          -  No prior bone marrow or peripheral blood stem cell transplantation

          -  At least 2 weeks since prior interferon alfa (phase I [closed to accrual as of
             7/9/03])

        Chemotherapy:

          -  See Disease Characteristics

          -  At least 6 weeks since prior busulfan (phase I [closed to accrual as of 7/9/03] )

          -  At least 2 weeks since prior cytarabine (phase I [closed to accrual as of 7/9/03])

          -  No concurrent chemotherapy

          -  Concurrent hydroxyurea allowed during the first 3 months of study

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified

        Other:

          -  At least 4 weeks since prior investigational agents other than imatinib mesylate
             (phase I [closed to accrual as of 7/9/03])

          -  No concurrent grapefruit juice

          -  Concurrent anagrelide hydrochloride allowed during the first 3 months of study