A PHASE-I STUDY OF INTRA-CAROTID ARTERY INFUSION OF CIS-DIAMMINEDICHLOROPLATINUM(II) IN PATIENTS WITH RECURRENT MALIGNANT INTRA-CEREBRAL TUMORS

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  • 1 January 1982
    • journal article
    • research article
    • Vol. 42  (5) , 2059-2062
Abstract
A Phase I study of intracarotid cis-diamminedichloroplatinum was performed in 11 patients with intracerebral tumors (5 glioblastoma, 4 melanoma, 1 meningeal sarcoma, 1 lung carcinoma) progressing after radiation .+-. chemotherapy. The internal carotid artery was temporarily cannulated by a percutaneous transfemoral approach. All patients received i.v. heparin, mannitol and fluids; 7 received dexamethasone, 50 mg i.v., twice the day before and the day of treatment. Intracarotid cis-diamminedichloroplatinum, 60-100 mg/m2 in 175-250 ml 0.45% NaCl solution with 1000 U heparin was infused over 1 h. Six patients received 2 or more courses (maximum of 6) at 2- to 8-wk intervals. Gastrointestinal toxicity was mild to moderate. Ototoxicity was minor. CNS toxicity was focal, severe, permanent and possibly due to embolus in 1 patient at 75 mg/m2; focal and reversible in 1 patient at 100 mg/m2; and generalized but reversible in 1 patient at 75 mg/m2. Possible CNS toxicity was noted in 2 additional patients. Two patients with CNS toxicity developed permanent ipsilateral retinal toxicity; 1 patient without CNS toxicity developed bilateral decreased visual and auditory acuity 2 wk after his 6th treatment. Renal and hematological toxicity and orbital pain were mild. Response status included the following: early death, 1; probable responses, 6 (2+, 4+, 6, 6+, 8 and 8+ mo); stabilization, 2 (3+ and 4 mo.); and failure, 2. Cis-diamminedichloroplatinum (60 mg/m2) is recommended every 2-4 wk for Phase II studies. Severe CNS and retinal toxicity are possible.

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