RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with corticosteroids may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose corticosteroids in treating older patients with primary CNS non-Hodgkin's lymphoma.

Condition	Treatment or Intervention	Phase
primary central nervous system lymphoma intraocular lymphoma	Drug: methylprednisolone  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy  Procedure: steroid therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Assess the effectiveness of high dose methylprednisolone following whole brain radiation therapy in maintaining response and preventing recurrence in elderly patients with primary central nervous system non-Hodgkin's lymphoma.
• Assess the toxic effects of this therapy in these patients.
• Assess the survival rate of these patients after this therapy.
• Identify the anatomic rates of recurrence and frequency of systemic involvement in these patients.
• Identify the factors that appear to be associated with outcome in these patients.

OUTLINE: Patients receive whole brain radiation therapy (WBRT) daily 5 days a week for 4.5 weeks. High-dose methylprednisolone (MePRDL) begins 30 days after WBRT is completed and is administered IV over 15-30 minutes. During the first course only, high-dose MePRDL is administered on days 1-5, while on subsequent courses it is administered on day 1 only. Courses are repeated every 28 days until disease progression or unacceptable toxic effects are observed.

Patients are followed at 1 month after radiation therapy, then every 3 months for 2 years, then every 6 months for 3 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study within 6 years.

Ages Eligible for Study:  70 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions
• Intraocular lymphoma eligible, if not sole site of disease
• No occult systemic lymphoma
• Measurable or evaluable disease by CT or MRI scan
• No neoplastic meningitis or gross spinal cord involvement

PATIENT CHARACTERISTICS: Age:

• 70 and over

Performance status:

• ECOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No prior history of lymphoma
• No other active malignancy except basal cell skin cancer or carcinoma in situ of the cervix
• HIV negative
• No active peptic ulcer disease
• No uncontrolled diabetes mellitus
• No active pancreatitis
• No active bleeding
• No poorly controlled major psychiatric illness
• No serious uncontrolled infection

PRIOR CONCURRENT THERAPY: Biologic therapy:

• No prior bone marrow transplant

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiation therapy to brain or head and neck region

Surgery:

• No prior transplants (renal, hepatic, or cardiac)

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States
Canada, Saskatchewan
      Allan Blair Cancer Centre, Regina,  Saskatchewan,  S4T 7T1,  Canada

Study chairs or principal investigators

Brian Patrick O'Neill, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000066184; NCCTG-967351
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003278
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08