RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.

Condition	Treatment or Intervention	Phase
primary central nervous system lymphoma	Drug: cytarabine  Drug: methotrexate	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen.

PROTOCOL OUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death.

PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.

Ages Eligible for Study:  16 Years   -   60 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord
• No Burkitt's lymphoma or low grade T-cell lymphoma
• Must have at least 1 measurable lesion
• No AIDS-related primary central nervous system lymphoma (PCNSL)
• No disease confined to the eye without other localization in the CNS

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent treatment with immunosuppressive drug
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Corticosteroid use for less than 3 weeks allowed
• Radiotherapy: Not specified
• Surgery: No prior organ transplantation

--Patient Characteristics--

• Age: 16 to 60
• Performance status: Karnofsky 40-100%; Neurological functional status 0-3
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: No serious impairment of hepatic function
• Renal: No serious impairment of renal function; Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min
• Cardiovascular: No serious impairment of cardiac function
• Other: HIV negative; No congenital or acquired immunodeficiency syndrome; No prior/concurrent systemic lymphoma; No prior malignancy except: Adequately treated non-melanoma skin cancer; Carcinoma in situ of the cervix uteri; Not pregnant; No severe uncontrolled infection

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
Netherlands
      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands
      Academisch Ziekenhuis Utrecht, Utrecht,  3508 GA,  Netherlands
      Atrium Medical Centre, HEERLEN,  6419 PC,  Netherlands
      Dr. Bernard Verbeeten Instituut, Tilburg,  5042 SB,  Netherlands
      Rotterdam Cancer Institute, Rotterdam,  3075 EA,  Netherlands

Study chairs or principal investigators

Patrice P. Carde,  Study Chair,  EORTC Lymphoma Cooperative Group   

Study ID Numbers:  CDR0000065724; EORTC-20962
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003061
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08