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

Alternate Title

Combination Chemotherapy in Treating Older Patients With Primary CNS Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	60 and over		EORTC-26952

Objectives

I.  Confirm the value of chemotherapy alone (MTX/ARA-C/PCB/CCNU/MePRDL) as 
initial treatment for PCNSL in patients 60 years and over.

Entry Criteria

Disease Characteristics:

Histologically confirmed CNS parenchymal non-Hodgkin's lymphoma by brain biopsy
 Cytology analysis from cerebrospinal fluid or vitrectomy consistent with
  lymphoma also accepted

At least one measurable lesion on a CT scan within 3 weeks prior to inclusion

No extracerebral lymphoma location (except eyes)
 No prior history of systemic lymphoma

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No prior chemotherapy

Endocrine therapy:
 No more than 3 weeks of prior corticosteroid therapy

Radiotherapy:
 Not specified

Surgery:
 Not specified

Patient Characteristics:

Age:
 60 and over

Performance status:
 Karnofsky 40-100%

Hematopoietic:
 WBC greater than 3,500/mm3
 Platelet count greater than 130,000/mm3
 
Hepatic:
 Bilirubin less than 2 times upper limit of normal
 SGOT less than 2 times upper limit of normal

Renal:
 Creatinine less than 1.47 mg/dL OR
 Creatinine clearance greater than 60 mL/min

Other:
 HIV negative
 No prior transplants (renal, hepatic, cardiac, bone marrow)
 No serious uncontrolled infection

Expected Enrollment

There will be an accrual of 31-50 patients.

Outline

The first course of chemotherapy with MTX, ARA-C, PCB, CCNU, and MePRDL lasts 
for 3 weeks.  Specifically, MTX infusions (1 gr/m2) are repeated 3 times with 
a 10 day interval between each.  CCNU and PCB are taken orally at day 1 and 
from day 1 to 7, respectively.  MTX and ARA-C are delivered intrathecally at 
days 1, 5, 10, and 15 through a lumbar puncture or subcutaneous reservoir 
implanted surgically and in direct communication with the ventricule.  MePRDL 
is administered intravenously or orally every other day during 3 weeks and 
then orally for 3 additional weeks.  A complete clinical and radiological 
evaluation is performed at day 45.  If a complete or a partial response is 
obtained, 5 cycles of maintenance therapy are given every 6 weeks.  The 
maintenance therapy includes MTX infusion for day 1, CCNU on day 1, PCB from 
day 1 to 7, and intrathecal MTX and ARA-C at day 1.

If patients do not respond after the first course of chemotherapy or if 
relapse occurs during the maintenance therapy, patients are taken off the 
study and the investigator chooses between whole brain radiotherapy and/or a 
second line chemotherapy protocol.

In case of intraocular lymphoma with PCNSL, ocular radiotherapy by lateral 
fields is required with the chemotherapy.

Follow-ups are after treatment every 2 months the first year, every 4 months 
the second year, and every 6 months thereafter.

Hoang-Xuan K, Taillandier L, Chinot O, et al.: Chemotherapy alone as initial treatment for primary CNS lymphoma in patients older than 60 years: a multicenter phase II study (26952) of the European Organization for Research and Treatment of Cancer Brain Tumor Group. J Clin Oncol 21 (14): 2726-31, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Khe Hoang-Xuan, MD, Protocol chair		Ph: 33-1-42-160-381 Email: khe.hoang-xuan@pst.ap-hsp-paris.fr