Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Rituximab; Cytarabine; Dexamethasone; Leucovorin; Methotrexate; Procarbazine; Vincristine
Intervention description: Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.; 3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14; 16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6; 25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10; 3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9
For patients with meningeal involvement additionally:
12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture; 100 mg/m2 PO daily x 7 days Weeks 1, 5, 9; 1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap
Intervention MeSH terms: Leucovorin; Cytarabine; Dexamethasone; Dexamethasone acetate; Rituximab; Methotrexate; Vincristine; Procarbazine; Dexamethasone 21-phosphate; BB 1101; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: primary central nervous system non-Hodgkin lymphoma

Summary:

      RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
      ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others
      interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy,
      such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine,
      work in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving rituximab together with combination chemotherapy may kill
      more cancer cells.

      PURPOSE: This phase II trial is studying how well giving rituximab together with combination
      chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed non-Hodgkin's lymphoma by brain biopsy

          -  Patients with inconclusive biopsy or patients who are not candidates for biopsy must
             have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:

               -  Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid
                  population as defined by cell surface markers or immunoglobulin gene
                  rearrangement studies

               -  Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the
                  posterior chamber or vitreous by ophthalmological examination

          -  Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by
             pretreatment MRI/CT scan

               -  Meningeal or vitreous involvement constitutes evaluable but not measurable
                  disease

               -  If an excisional, rather than a needle biopsy was done, measurable disease must
                  be present on a postoperative scan (not a PET-CT scan)

          -  ECOG performance status 0-3

          -  Absolute granulocyte count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Bilirubin ≤ upper limit of normal (ULN)

          -  SGOT ≤ 2.0 times ULN

          -  Creatinine clearance ≥ 50 mL/min

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Pregnant or nursing

          -  HIV-1 positivity

          -  Other malignancy within the past 5 years except basal cell skin cancer or any
             carcinoma in situ

          -  Pre-existing immunodeficiency

          -  Hepatitis B surface antigen positivity

          -  Systemic lymphoma (as determined by pre-registration CT scans and physical
             examination)

          -  Prior chemotherapy or radiotherapy for primary central nervous system lymphoma

          -  Prior organ or bone marrow transplantation