A Phase II Study of Intensive Methotrexate and Cytarabine Followed by High Dose Beam Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

OBJECTIVES: I. Assess the efficacy and treatment-related toxicity of high-dose chemotherapy comprising carmustine, etoposide, cytarabine, and melphalan followed by autologous peripheral blood stem cell transplantation in patients with primary central nervous system lymphoma. II. Determine the safety of this regimen in these patients. III. Determine the efficacy of this regimen, in terms of 2-year disease-free survival, in these patients. IV. Assess neurologic outcome using serial neurologic examinations in patients treated with this regimen.

OUTLINE: Induction therapy: Patients receive methotrexate (MTX) IV over 2 hours once on weeks 1, 3, 5, and 7. Patients who respond to treatment receive a fifth dose of MTX on week 9 followed by cytarabine (ARA-C) IV over 3 hours beginning 3 days after completion of MTX infusion and continuing daily for 2 days. Filgrastim (G-CSF) is administered daily beginning 2 days after completion of ARA-C infusion and continuing until harvest of peripheral blood stem cells (PBSC). Patients receive a second course of ARA-C IV beginning 1 month after completion of the first course of ARA-C and continuing daily for 2 days. G-CSF is then administered daily for about 2 weeks. High-dose chemotherapy/transplantation: Patients with stable or responding disease after induction therapy receive high-dose carmustine IV over 1-2 hours on day -7, etoposide IV over 1 hour every 12 hours and ARA-C IV every 12 hours on days -6 to -3, and melphalan IV on day -2. PBSC are reinfused on day 0. Patients receive G-CSF beginning on day 1 and continuing until blood counts recover. Patients are followed monthly for 3 months, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.