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Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF) (NCT00003929)

National Cancer Institute (NCI)
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.
  • Biological: filgrastim
    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.
    • Drug: lomustine
      Oral lomustine on day 1. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
      • Drug: procarbazine hydrochloride
        Oral procarbazine on days 1-10 and days 22-31. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
        • Radiation: radiation therapy
          Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy.
          Ages eligible for Study
          all
          Genders eligible for Study
          All
          Accepts Healthy Volunteers
          No
          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.

          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.

          1 locations

          United States (1)
          • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
            Not specified
            Cleveland, Ohio, United States, 44106-5065
          Status:
          withdrawn
          Type:
          Interventional
          Phase:
          Start:
          31 May, 1998
          Updated:
          15 March, 2012
          Participants:
          0
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