Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients with Newly Diagnosed Primary Central Nervous System Lymphoma

Inclusion Criteria

• Subjects with histopathologic confirmation of intermediate or high-grade primary central nervous system lymphoma (PCNSL) as documented by brain biopsy, or cytology (analysis from cerebral spinal fluid [CSF] or vitrectomy), and cluster of differentiation 20 (CD20) positive; whenever possible, the tumor should be characterized by immunophenotype
• Subjects must be =< 90 days from diagnosis of PCNSL in the brain or spine; time from pathologic diagnosis to initiation of treatment should be specified; subjects with history of only ocular lymphoma are eligible if < 90 days since documented brain parenchymal disease (by imaging or by biopsy)
• Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance score =< 3 (Karnofsky >= 30)
• Hematocrit >= 25% (may be reached by transfusion) (performed within 14 days of registration)
• White blood cell count >= 2.5 x 10^3/mm^3 (performed within 14 days of registration)
• Absolute granulocyte count >= 1.2 x 10^3/mm^3 (performed within 14 days of registration)
• Platelets >= 100 x 10^3/mm^3 (or >= lower limit of institutional normal value) (performed within 14 days of registration)
• Calculated creatinine clearance (Cr Cl) >= 50 ml/min (performed within 14 days of registration); eligible for full dose methotrexate
• Calculated Cr Cl >= 30 ml/min (performed within 14 days of registration); eligible for reduced dose methotrexate
• Bilirubin =< 2.0 x upper limit of institutional normal value (performed within 14 days of registration)
• The subject may have had other systemic chemotherapy for PCNSL during the 90 days since PCNSL diagnosis; prior systemic chemotherapy must have been given at least 4 weeks prior to study entry (6 weeks for nitrosourea agents), with the exceptions of methotrexate and rituximab which may have been given at least 10 days prior; ocular lymphoma treatment may have been given any time prior to study entry; if the subject has undergone treatment for parenchymal disease and the parenchymal disease has progressed on a stable or increasing dose of steroids, the subject is not eligible for enrollment
• Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study treatment and for the duration of study treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Subjects with a bone marrow biopsy which shows microscopic, low-level involvement of lymphoma are eligible
• Subject with seropositivity for hepatitis B or hepatitis C must be cleared by hepatology service prior to participating in treatment protocol

Exclusion Criteria

• Prior cranial or spinal radiotherapy
• Subjects with radiographic signs of excessive intra-cranial mass effect with associated rapid neurologic deterioration, and/or spinal block, are unsafe to undergo BBBD chemotherapy and are not eligible
• Uncontrolled (over the last 30 days), clinically significant confounding medical conditions
• Seropositivity for the human immunodeficiency virus
• Systemic lymphoma
• Subjects who have a positive serum human chorionic gonadotropin (hCG), are pregnant or lactating are ineligible
• Known allergy to any of the study agents
• Subjects who are at significant risk for general anesthesia