Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital
• Treatments: Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Leucovorin; Liposomal doxorubicin; Mesna; Methotrexate; Rituximab; Vincristine

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.