S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: filgrastim; cyclophosphamide; cytarabine; daunorubicin; dexamethasone; doxorubicin; leucovorin; mercaptopurine; methotrexate; mitoxantrone; Asparaginase; prednisone; thioguanine; vincristine; radiation therapy; allopurinol; bactrim
Intervention description: As needed per physician discretion; Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1; Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13; Induction: 60 mg/m2/d; IV; days 1, 2, and 3; Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28; Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22; For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC < 3,000; Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs; Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs; Induction 2: 80 mg/m2; IV; day 3; Induction: 2,000 IU/m2; IM or IV; day 15; Induction: 60 mg/m2/d; PO or IV; days 1-35; Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14; Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22; For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.; 300 mg/d PO Days 1-7; 1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone
Intervention MeSH terms: Leucovorin; Cytarabine; Trimethoprim, Sulfamethoxazole Drug Combination; Dexamethasone; Prednisone; Cyclophosphamide; Doxorubicin; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mitoxantrone; Mercaptopurine; Thioguanine; Allopurinol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: L1 adult acute lymphoblastic leukemia; L2 adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy), and giving the drugs in different combinations may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
      patients with newly diagnosed acute lymphoblastic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Morphologically confirmed acute lymphoblastic leukemia (ALL), meeting any of the
             following criteria:

               -  FAB class L1 or L2 disease

               -  Mixed lineage ALL

          -  Ph-negative/BCR/ABL-negative

          -  Newly diagnosed disease

          -  Patients with the following diagnoses are not eligible:

               -  FAB class L3 ALL

               -  Non-Hodgkin's lymphoma

               -  Chronic myelogenous leukemia in lymphoid blast crisis

               -  Mixed lineage acute myeloid leukemia

               -  Acute minimally differentiated myeloid leukemia (M0)

          -  Must be registered on protocols SWOG-9007 AND SWOG-S9910

        PATIENT CHARACTERISTICS:

        Age

          -  18 to 64

        Performance status

          -  Zubrod 0-3

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

          -  No chronic liver disease

          -  Hepatitis panel, including hepatitis B and C, negative

               -  History of hepatitis A with positive antibody allowed

        Renal

          -  Creatinine ≤ 1.5 times upper limit of normal OR

          -  Creatinine clearance > 60 mL/min

        Cardiovascular

          -  Left ventricular function normal

               -  Ejection fraction ≥ 50% by MUGA or 2-dimensional echocardiogram

          -  No symptomatic congestive heart failure

          -  No coronary artery disease

          -  No cardiomyopathy

          -  No uncontrolled arrhythmia

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  HIV negative

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or II cancer in complete remission

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior remission induction chemotherapy for ALL

               -  Prior hydroxyurea to control WBC count allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  Not specified

        Surgery

          -  Not specified

        Other

          -  No other prior treatment for ALL