Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma

Inclusion criteria

• Histological or cytological diagnosis of non-Hodgkin's lymphoma.
• Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy.
• Disease exclusively localized into the central nervous system, cranial nerves or eyes.
• Untreated patients (patients treated with steroids alone are eligible).
• At least one measurable lesion.
• Age 18 - 75 years.
• ECOG performance status < 3
• HBsAg-negative and Ab anti-HCV-negative serologic status.
• No known HIV disease or immunodeficiency.
• Adequate bone marrow (PLT > 100000 mm3, Hb ≥ 9 g/dl, ANC ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 mL/min), cardiac (VEF ≥ 50%), and hepatic function (total serum bilirubin < 3 mg/dL, AST/ALT and gGT < 2 per upper normal limit value).
• No previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded).
• Absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
• Non-pregnant and non-lactating status for female patients. Adequate contraceptive measures during study participation for sexually active patients of childbearing potential.
• No concurrent treatment with other experimental drugs.
• Informed consent signed by the patient before registration