Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Condition: Leukemia; Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia
Intervention: filgrastim; rituximab; cyclophosphamide; cytarabine; dexamethasone; doxorubicin hydrochloride; etoposide; ifosfamide; leucovorin calcium; methotrexate; prednisone; vincristine sulfate; Allopurinol
Intervention description: 5 ug/kg/day sub Q injection day 7 until ANC>5000/ul courses II-VII; Day 8 course II 50 mg/sq m IV infusion: d 8 course IV & VI 375mg/sq m IV Day 10 course II: 325 mg/sq m IV infusion Day 12 course II: 375 mg/sq m IV infusion; 200 mg/sq m/day IV infusion over 5-15 min days 1-5, courses I, III, V, VII; 1 g/sq m/day IV infusion Days 4 & 5, courses II, IV, VI; 10mg/sq m PO or IV Days 1-5 courses II-VII; 25 mg/sq m/day IV infusion Days 4 & 5 courses III,V, VII; 80 mg/sq m/day IV infusion Days 4 & 5 courses II, IV, VI; 800 mg/sq m/day IV infusion Days 1-5 courses II, IV, VI; 25mg/sq m IV infusion over 15 min then 10 mg IV q 6 hrs until serum MTX <10nM, courses II-VII; 1.5 g/sq m IV infusion Day 1 courses II-VII; 60 mg/sq m PO/day Days 1-7 course I; 2 mg IV push Day 1 courses II-VII; 300 mg/day PO Days 1-14, course I
Intervention MeSH terms: Leucovorin; Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Ifosfamide; Rituximab; Doxorubicin; Liposomal doxorubicin; Methotrexate; Etoposide; Vincristine; Allopurinol; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: untreated adult acute lymphoblastic leukemia; L3 adult acute lymphoblastic leukemia; stage I adult Burkitt lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma; contiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult Burkitt lymphoma

Summary:

      RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill
      them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
      chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
      die. Colony-stimulating factors such as filgrastim may increase the numbers of immune cells
      found in bone marrow or peripheral blood and may help a person's immune system recover from
      the side effects of chemotherapy. Combining chemotherapy with rituximab and filgrastim may
      kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combining rituximab with chemotherapy
      and filgrastim in treating patients who have Burkitt's lymphoma or Burkitt's leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically, cytogenetically, or immunophenotypically confirmed Burkitt's leukemia
             or Burkitt's or Burkitt-like lymphoma

               -  L3 morphology surface IgG expression

               -  Cytogenetic evidence for t(8;14), t(8;22), or t(2;8)

          -  Previously untreated disease except hydroxyurea for leukocytosis

          -  CNS involvement allowed

          -  Patients with Burkitt's leukemia or Burkitt's lymphoma with bone marrow involvement
             must also be enrolled on CALGB-8461

          -  Patients with Burkitt's leukemia must also be enrolled on CALGB-9665

        PATIENT CHARACTERISTICS:

        Age:

          -  16 and over

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Other:

          -  HIV negative

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No concurrent interleukin-11

        Chemotherapy:

          -  See Disease Characteristics

          -  No other concurrent chemotherapy

        Endocrine therapy:

          -  No concurrent hormonal therapy except for non-disease-related conditions (e.g.,
             insulin for diabetes)

          -  No concurrent steroids except for adrenal failure

        Radiotherapy:

          -  No concurrent palliative radiotherapy except whole-brain irradiation for documented
             CNS disease