Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
Rituximab, Chemotherapy, and Filgrastim in Treating Patients With Burkitt's Lymphoma or Burkitt's Leukemia
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.
OBJECTIVES:

 -  Determine the complete response rate in patients with previously untreated Burkitt's
 lymphoma or Burkitt's leukemia treated with rituximab and high-intensity chemotherapy
 with filgrastim (G-CSF) support.

 -  Determine the progression-free and overall survival of patients treated with this
 regimen.

 -  Determine the feasibility and toxicity of this regimen in these patients.

 OUTLINE: This is a multicenter study. Patients are stratified according to disease (leukemia
 vs lymphoma).

 -  Course 1: Patients receive cyclophosphamide IV over 5-15 minutes daily on days 1-5 and
 oral prednisone on days 1-7. Allopurinol PO will be given on days 1-14.

 -  Courses 2, 4, and 6: Patients receive ifosfamide IV over 1 hour daily on days 1-5;
 vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1; leucovorin
 calcium IV over 15 minutes every 6 hours on day 2; cytarabine IV over 2 hours on days 4
 and 5 and etoposide IV over 1 hour daily on days 4 and 5; oral dexamethasone daily on
 days 1-5; and methotrexate and cytarabine intrathecally (IT) on day 1. During course 2,
 patients receive rituximab IV over 1-4 hours on days 8, 10, and 12. During courses 4 and
 6, patients receive rituximab IV over 1 hour on day 8. Patients also receive filgrastim
 (G-CSF) subcutaneously (SC) beginning on day 7 and continuing until blood counts
 recover.

 -  Courses 3, 5, and 7: Patients receive cyclophosphamide IV over 5-15 minutes daily on
 days 1-5; vincristine IV over 10 minutes and methotrexate IV over 24 hours on day 1;
 leucovorin calcium IV every 6 hours on day 2; doxorubicin IV daily on days 4 and 5; oral
 dexamethasone daily on days 1-5; methotrexate and cytarabine IT on day 1; and rituximab
 IV over 1 hour on day 8. Patients also receive G-CSF as in courses 2, 4, and 6. After
 course 3, treatment continues in the absence of disease progression or unacceptable
 toxicity.

 Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
 annually for 5 years.

 PROJECTED ACCRUAL: A total of 100 patients (50 per stratum) will be accrued for this study
 within 3 years.
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