Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF)
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
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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.
Patients with a CR after 6 weeks receive one additional course of chemotherapy prior to radiotherapy. Patients with a PR, stable disease, or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy.
Scot C. Remick, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|