Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Leukemia
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.
OBJECTIVES:

 Primary

 -  Determine the overall response rate, 1-year event-free survival, and overall survival of
 adult patients with newly diagnosed Burkitt or atypical Burkitt lymphoma or leukemia
 treated with dose-intensified induction therapy comprising cyclophosphamide,
 vincristine, prednisone, and rituximab followed by consolidation therapy comprising
 rituximab and high-dose cyclophosphamide.

 -  Determine the grade 3 or higher non-hematologic toxic effects and overall tolerability
 of this regimen in these patients.

 Secondary

 -  Determine the 3-year event-free survival and overall survival of patients treated with
 this regimen.

 -  Determine the general patterns of CNS and systemic relapse in patients treated with this
 regimen.

 OUTLINE: This is a multicenter study.

 -  Dose-intensified CVP induction therapy: Patients receive cyclophosphamide IV and
 vincristine IV on day 1. Patients also receive oral prednisone on days 1-5 and rituximab
 IV on days 1 and 8, and high-dose methotrexate IV with leucovorin calcium IV rescue on
 day 8. Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on
 day 3 and continuing until blood counts recover. Treatment repeats approximately every
 14 days for 2 courses.

 -  CNS therapy: Patients receive cytarabine intrathecally (IT) with or without
 hydrocortisone IT on days 1, 4, and 11 of each induction therapy course. Patients with
 evidence of CNS involvement by lymphoma continue to receive cytarabine IT twice weekly
 during any induction therapy treatment delay. Patients who demonstrate CSF clearance
 receive cytarabine IT once weekly for 4 doses and then once every other week for 4 doses
 during consolidation therapy. Patients with disease progression during induction therapy
 or persistent CNS involvement by lymphoma are removed from the study. All other patients
 proceed to consolidation therapy.

 -  Consolidation therapy: Patients receive rituximab IV on day -4 and high-dose
 cyclophosphamide IV on days -3, -2, -1, and 0. Patients receive G-CSF SC once daily
 beginning on day 6 and continuing until blood counts recover OR pegfilgrastim SC once on
 day 6. Patients then receive rituximab IV once weekly for 4 weeks in the absence of
 disease progression or unacceptable toxicity.

 After completion of study treatment, patients are followed periodically for 3 years.

 PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
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