Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: filgrastim; rituximab; cytarabine; etoposide; leucovorin calcium; methotrexate; temozolomide
Intervention description: 5 mcg/kg subQ injection daily Day 14 until ANC > or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6); 375 mg/sq m IV infusion (max rate of 400 mg/hr) on Days 3, 10, 17, & 24 of Cycle 1 nad Days 3 & 10 of Cycle 2; 2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6; 5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6; 100 mg/sq m IV infusion q 6 hrs starting 24 hrs after ea MTX dose until serum MTX < or = 0.05uM Cycles 1-5.; 8 g/sq m IV infusion over 4 hrs Days 1 & 15 Cycles 1, 2, & 3; Day 15 Cycle 4 and Day 1 Cycle 5.; 150 mg/sq m PO Days 7-11 Cycles 1-5.
Intervention MeSH terms: Leucovorin; Cytarabine; Rituximab; Methotrexate; Etoposide; Temozolomide; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Healthy volunteers: No
Keywords: primary central nervous system non-Hodgkin lymphoma

Summary:

      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. 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 rituximab with combination chemotherapy may kill
      more cancer cells.

      PURPOSE: This phase II trial is studying how well rituximab given with combination
      chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed newly diagnosed primary CNS lymphoma confirmed by 1 of the
             following methods:

               -  Brain biopsy or resection

               -  Cerebrospinal fluid (CSF) cytology

                    -  Positive CSF cytology with or without measurable intracranial disease

          -  No evidence of systemic non-Hodgkin's lymphoma

               -  CT scan or MRI of the chest, abdomen, and pelvis AND bilateral bone marrow biopsy
                  or unilateral biopsy with a 2cm core biopsy specimen that is negative for
                  extracerebral source of lymphoma

          -  Measurable contrast-enhancing disease by MRI of the brain and spine (plus gadolinium)
             unless CSF cytology positive

          -  No evidence of pleural effusions or ascites

        PATIENT CHARACTERISTICS:

        Age

          -  Any age

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

        Hepatic

          -  ALT and AST ≤ 2 times upper limit of normal

          -  Bilirubin ≤ 2 mg/dL

        Renal

          -  Creatinine clearance ≥ 50 mL/min

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for at least 6 months
             after study participation

          -  HIV negative

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Concurrent steroids for the management of symptoms related to lymphoma allowed

        Radiotherapy

          -  No concurrent palliative radiotherapy

        Surgery

          -  Not specified