Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Central Nervous System Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma.
|Lymphoma||Biological: filgrastim Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: methotrexate Procedure: peripheral blood stem cell transplantation||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||September 1998|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003632
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Lauren E. Abrey, MD||Memorial Sloan Kettering Cancer Center|