Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)
16 Years
60 Years
Both
Lymphoma
Trial Information
Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Philip Poortmans, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Dr. Bernard Verbeeten Instituut
Authority:
United States: Federal Government
Study ID:
EORTC-20962
NCT ID:
NCT00003061
Start Date:
July 1997
Completion Date:
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
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