Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Not Recruiting

Trial ID: NCT00335140


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.

Official Title

Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

Stanford Investigator(s)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery


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

      - 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

   - Prior chemotherapy or radiotherapy for primary central nervous system lymphoma

   - Prior organ or bone marrow transplantation


biological: rituximab

drug: cytarabine

drug: dexamethasone

drug: methotrexate

drug: Leucovorin

drug: Procarbazine

drug: Vincristine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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