rituximab, chemotherapy, and filgrastim in treating patients with burkitt's lymphoma or burkitt's leukemia

Conditions: Leukemia; 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.

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.

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

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