Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
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 tumor cells. Combining radiation therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary CNS lymphoma.
|Lymphoma||Drug: cytarabine Drug: methotrexate Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)|
|Study Start Date:||July 1997|
|Primary Completion Date:||March 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-AIDS related primary central nervous system lymphoma. II. Assess the response rate and safety of this chemotherapy regimen.
OUTLINE: Patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. Methotrexate (MTX) IV is administered over 40-60 minutes on days 1 and 15. Cytarabine (AraC) is administered intrathecally on days 1 and 15. The second course of chemotherapy begins on day 29 or after bone marrow recovery. Radiation therapy begins no later than 3 weeks after completing chemotherapy. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003061
|Leuven, Belgium, B-3000|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Atrium Medical Centre|
|Heerlen, Netherlands, 6419 PC|
|Academisch Ziekenhuis Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|Rotterdam Cancer Institute|
|Rotterdam, Netherlands, 3075 EA|
|Dr. Bernard Verbeeten Instituut|
|Tilburg, Netherlands, 5042 SB|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3508 GA|
|Study Chair:||Philip Poortmans, MD, PhD||Dr. Bernard Verbeeten Instituut|