Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Primary CNS Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	16 to 60		EORTC-20962 NCT00003061

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.

Entry 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

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

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

Expected Enrollment

A maximum of 50 patients will be accrued.

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.

Harder H, Holtel H, Bromberg JE, et al.: Cognitive status and quality of life after treatment for primary CNS lymphoma. Neurology 62 (4): 544-7, 2004.[PUBMED Abstract]

Poortmans PM, Kluin-Nelemans HC, Haaxma-Reiche H, et al.: High-dose methotrexate-based chemotherapy followed by consolidating radiotherapy in non-AIDS-related primary central nervous system lymphoma: European Organization for Research and Treatment of Cancer Lymphoma Group Phase II Trial 20962. J Clin Oncol 21 (24): 4483-8, 2003.[PUBMED Abstract]

Kluin-Nelemans JC, Poortmans P, Haaxma-Reicher H, et al.: Final results of the EORTC phase II trial 20962 evaluating high-dose MTX-based chemotherapy followed by consolidating radiotherapy in non-Aids related primary central nervous system lymphoma. [Abstract] Blood 100 (11 pt 1): A-3071, 776a, 2002.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Philip Poortmans, MD, PhD, Protocol chair		Ph: 31-13-594-7765 Email: poortmans.ph@bvi.nl

Registry Information
Official Title		Evaluating the MBVP Chemotherapy Schedule Followed by Consolidating Radiotherapy in Non-AIDS Related Primary Central Nervous System Lymphoma (NAPCL)
Trial Start Date		1997-07-14
Registered in ClinicalTrials.gov		NCT00003061
Date Submitted to PDQ		1997-08-18
Information Last Verified		2004-08-09