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Phase III Trial 8301 compared intra-arterial (IA) versus intravenous (IV) BCNU (200 mg/m2 q 8 wk), each regimen without or with IV 5-FU (1 g/m2/d × 3 two wks after BCNU), plus radiation therapy, in the treatment of malignant glioma. Actuarial analysis (logrank) demonstrated worse survival for the IA group (p=0.07, and for those receiving at least one course, p=0.03). Serious toxicity was observed in the IA group, including irreversible encephalopathy (8.4%) and visual loss ipsilateral to the infused carotid artery. 5-FU did not influence survival. IA BCNU is neither safe nor effective. Phase II Trial 8420, compared IA cisplatin, 60 mg/m2 every 4 weeks, versus IV PCNU, 100 mg/m2 every 8 weeks. There was no statistical difference in survival between patients treated with IV PCNU and those treated with IA cisplatin. The median survival of the IV PCNU patients was 11.8 months; that of the IA cisplatin patients was 9.4 months. The incidence of encephalopathy was substantially less than with IA BCNU; the incidence of severe encephalopathy was 1.3%.