Phase-I Trial of Intracarotid BCNU and Cisplatin in Patients with Malignant Intracerebral Tumors

Eighteen patients with progressive or recurrent intracerebral malignant neoplasms after cranial radiation therapy were entered in a phase-I trial of intracarotid bis-chloroethylnitrosourea (BCNU) and cisplatin. Thirty-six courses of varying doses of BCNU and cisplatin were infused intraarterially via a percutaneous, trasfemoral approach. Courses were repeated every 4-6 weeks upon patients' recovery from toxicity. Intraarterial cisplatin or BCNU alone was administered if the blood counts were still subnormal. CT scans and neurologic examinations were performed monthly. Major toxic effects included ipsilateral retinal (amaurosis) in 4 patients and neurologic toxicity in 2 patients (minor focal seizure, reversible obtundation in one patient, and transient hemiparesis in one patient). One patient was infused by a catheter inserted into the supraclinoid internal carotid artery and had no further visual deterioration and no major side effects. Tumor regression was observed in patients previously treated with radiation and/or systemic chemotherapy, including 4 of 9 who had recurrent malignant gliomas, and 2 of 9 who had meta static tumors. Recommended dose for phase-II trials is BCNU 100 mg/m² and cisplatin 60 mg/m² every 4-6 weeks. Retinal and neurologic toxicity are possible side effects.