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 cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. Colony-stimulating factors such as filgrastim allow doctors to give higher doses of chemotherapy drugs to kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.

Condition	Treatment or Intervention	Phase
AIDS-related primary CNS lymphoma primary central nervous system lymphoma	Drug: filgrastim  Drug: lomustine  Drug: procarbazine	Phase II

Further Study Details: 

OBJECTIVES: I. Determine response rate, response duration, and survival of patients with AIDS-related or immunocompetent primary central nervous system lymphoma after treatment with oral lomustine and procarbazine, filgrastim (G-CSF), and radiotherapy.

II. Determine toxicity of this combined modality in these patients.

III. Determine quality of life of these patients.

PROTOCOL OUTLINE: Patients are stratified by CD4 count (50/mm3 and under vs greater than 50/mm3).

Patients receive oral lomustine on day 1 and oral procarbazine on days 1-10 and days 22-31. Filgrastim (G-CSF) is administered subcutaneously daily on days 12-21 and days 33-42, until absolute neutrophil counts recover. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy. Patients with a partial response, stable disease, or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy. Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy.

Quality of life is assessed prior to therapy, at 3 and 6 weeks, and then every 2 months following radiotherapy.

Patients are followed every 2 months until death.

PROJECTED ACCRUAL: Approximately 16 patients will be accrued for this study.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven AIDS-related non-Hodgkin's lymphoma of the CNS or non AIDS-related, non-Hodgkin's lymphoma of CNS also eligible, if not eligible for higher priority clinical trial

--Prior/Concurrent Therapy--

• Biologic therapy:
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Steroids may be used concurrently. Doses should be as low as possible. Increases in steroids above study's upper limit will result in patient going off study.
• Radiotherapy: No prior radiotherapy
• Surgery: Prior surgical debulking allowed

--Patient Characteristics--

• Age: 0-120
• Performance status: ECOG 0-2
• Life expectancy: At least 6 weeks
• Hematopoietic: WBC at least 1500/ mm3; Platelets at least 50,000/mm3
• Hepatic: Serum bilirubin no greater than 3.0 mg/dL
• Renal: Serum creatinine no greater than 3.0 mg/dL
• Cardiovascular:
• Pulmonary:
• Other: Active infection(s) allowed if drug receiving treatment; No Zidovudine during combined modality chemotherapy and radition; Negative CSF cytology

Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Study chairs or principal investigators

Scot C. Remick,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000067118; CWRU-3496; NCI-G99-1533; CWRU-AMC-2A-93
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003929
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08