Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma of the central nervous system (CNS) including leptomeninges and the spinal cord No Burkitt's lymphoma or low grade T-cell lymphoma Must have at least 1 measurable lesion No AIDS-related primary central nervous system lymphoma (PCNSL) No disease confined to the eye without other localization in the CNS
PATIENT CHARACTERISTICS: Age: 16 to 60 Performance status: Karnofsky 40-100% Neurological functional status 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No serious impairment of hepatic function Renal: No serious impairment of renal function Creatinine no greater than 1.5 mg/dL OR Creatinine clearance no less than 50 mL/min Cardiovascular: No serious impairment of cardiac function Other: HIV negative No congenital or acquired immunodeficiency syndrome No prior/concurrent systemic lymphoma No prior malignancy except: Adequately treated non-melanoma skin cancer Carcinoma in situ of the cervix uteri Not pregnant No severe uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent treatment with immunosuppressive drug Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroid use for less than 3 weeks allowed Radiotherapy: Not specified Surgery: No prior organ transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | U.Z. Gasthuisberg | Leuven | Belgium | B-3000 | |
| 2 | Institut Gustave Roussy | Villejuif | France | F-94805 | |
| 3 | Atrium Medical Centre | Heerlen | Netherlands | 6419 PC | |
| 4 | Academisch Ziekenhuis Maastricht | Maastricht | Netherlands | 6202 AZ | |
| 5 | Rotterdam Cancer Institute | Rotterdam | Netherlands | 3075 EA | |
| 6 | Dr. Bernard Verbeeten Instituut | Tilburg | Netherlands | 5042 SB | |
| 7 | Academisch Ziekenhuis Utrecht | Utrecht | Netherlands | 3508 GA |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
Investigators
- Study Chair: Philip Poortmans, MD, PhD, Dr. Bernard Verbeeten Instituut
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EORTC-20962
- EORTC-20962