Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia
Intervention: Filgrastim; Rituximab; Cyclophosphamide; Cytarabine; Methotrexate; Prednisone; Hydrocortisone; Vincristine; Leucovorin
Intervention description: 5 mcg/kg/day starting on Day 3 after each R-CVP cycle and on Day 6 after HiCy.; 375 mg/m^2 on Day 1 and Day 8 of each R-CVP cycle. 375 mg/m^2 on Day -4 of HiCy and weekly for four weeks after HiCy.; 1500 mg/m^2 on Day 1 of each R-CVP cycle. 50 mg/kg/day on Days -3, -2, -1, and 0 of HiCy.; 100 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.; 3 g/m^2 on Day 8 of each cycle of R-CVP.; 100 mg on Days 1-5 of each cycle of R-CVP.; 50 mg intrathecal on Days 1, 4, and 11 of each cycle of R-CVP.; 1.4 mg/m^2 on Day 1 of each cycle of R-CVP.; 25 mg four times daily after methotrexate administration. Dosing continues until adequate methotrexate levels are reached.
Intervention MeSH terms: Leucovorin; Cytarabine; Prednisone; Hydrocortisone; Cyclophosphamide; Rituximab; Methotrexate; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 30 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: untreated adult acute lymphoblastic leukemia; L3 adult acute lymphoblastic leukemia; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma

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) may kill more cancer cells. Monoclonal antibodies, such as
      rituximab, can block cancer growth in different ways. Some block the ability of cancer cells
      to grow and spread. Others find cancer cells and help kill them or carry cancer-killing
      substances to them. Giving combination chemotherapy together with rituximab may kill more
      cancer cells.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with rituximab works in treating patients with newly diagnosed Burkitt's lymphoma or
      leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of 1 of the following:

               -  Classic, sporadic Burkitt's lymphoma

               -  Burkitt's leukemia (FAB L3 acute lymphoblastic leukemia)

               -  Atypical Burkitt/Burkitt's-like lymphoma or leukemia, defined by the following
                  criteria:

                    -  Characteristic morphologic features

                    -  High proliferative index AND Ki-67 ≥ 85%

          -  Any stage allowed

          -  Newly diagnosed or untreated disease

               -  Steroids allowed

        PATIENT CHARACTERISTICS:

        Age

          -  30 and over

        Performance status

          -  Not specified

        Life expectancy

          -  Not specified

        Renal

          -  No known irreversible renal dysfunction that would preclude treatment with high-dose
             cyclophosphamide

        Cardiovascular

          -  No known significant cardiac dysfunction that would preclude treatment with high-dose
             cyclophosphamide

        Other

          -  Not pregnant or nursing

          -  No known HIV positivity

          -  No other malignancy within the past 3 years except basal cell or squamous cell skin
             cancer or carcinoma in situ of the cervix

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy for lymphoma

               -  A maximum of 2 prior doses of intrathecal chemotherapy are allowed

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior radiation therapy for lymphoma

        Surgery

          -  Prior complete or incomplete surgical resection of lymphoma allowed