Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Condition: Burkitt Lymphoma; Non-Hodgkins Lymphoma; Atypical Burkitt Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Methotrexate; Leucovorin; Ifosfamide; Etoposide; Cytarabine; Mesna
Intervention description: Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1; Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A); Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A); Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A); Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle; Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A); High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle; High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle; Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle; High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle
Intervention MeSH terms: Leucovorin; Cytarabine; Cyclophosphamide; Ifosfamide; Rituximab; Doxorubicin; Methotrexate; Etoposide; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Burkitt Lymphoma; atypical Burkitt lymphoma; Non-Hodgkin's Lymphoma; rituximab

Summary:

      The purpose of this study is to learn more about how well a chemotherapy regime including
      rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented Burkitt or atypical Burkitt according to World Health
             Organization (WHO) criteria.

          -  Pathology must be reviewed at the Brigham and Women's Hospital (BWH).

          -  Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular
             dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance
             imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable
             disease.

          -  The following may not be used as the sole site of measurable or evaluable disease:
             *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease.

          -  Age > 18

          -  Laboratory data (within 2 weeks of study registration):

               -  ANC > 1500/ul;

               -  platelet > 100,000/ul;

               -  creatinine < 1.5 X normal;

               -  creatinine clearance > 60 ml/min;

               -  bilirubin < 1.5 X normal;

               -  AST and ALT < 2.5 X normal;

               -  alkaline phosphates < 3 X normal;

               -  HIV negative;

               -  cardiac ejection fraction > 50%.

        Exclusion Criteria:

          -  Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration
             for impending oncologic emergency are allowed.

          -  Uncontrolled bacterial, fungal, or viral infection.

          -  Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell
             carcinoma of the skin.

          -  Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients
             with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs)
             should document an forced expiratory volume at 1 second (FeV1), forced vital capacity
             (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing
             capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac
             symptomatology. The cardiac ejection fraction must be > 50%.

          -  Pregnancy. All males and females with reproductive potential must consent to use an
             effective form of contraception while on study.

          -  Major surgery within the previous 2 weeks.