Phase II Study of Methotrexate/Cytarabine/Procarbazine/Lomustine/Methylprednisolone (MTX/ARA-C/PCB/CCNU/MePRDL) for Immunocompetent Patients Over Age 60 With Primary CNS Lymphoma (PCNSL) (Summary Last Modified 08/1999)
Combination Chemotherapy in Treating Older Patients With Primary CNS Lymphoma
Basic Trial Information
|Phase II||Treatment||Closed||60 and over||EORTC-26952|
I. Confirm the value of chemotherapy alone (MTX/ARA-C/PCB/CCNU/MePRDL) as initial treatment for PCNSL in patients 60 years and over.
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
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
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
There will be an accrual of 31-50 patients.
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
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