Superselective intraarterial cerebral infusion of cetuximab after osmotic blood/brain barrier disruption for recurrent malignant glioma: phase I study

Abstract

Objective To establish a maximum tolerated dose of superselective intraarterial cerebral infusion (SIACI) of Cetuximab after osmotic disruption of the blood–brain barrier (BBB) with mannitol, and examine safety of the procedure in patients with recurrent malignant glioma.

Methods A total of 15 patients with recurrent malignant glioma were included in the current study. The starting dose of Cetuximab was 100 mg/m² and dose escalation was done to 250 mg/m². All patients were observed for 28 days post-infusion for any side effects.

Results There was no dose-limiting toxicity from a single dose of SIACI of Cetuximab up to 250 mg/m² after osmotic BBB disruption with mannitol. A tolerable rash was seen in 2 patients, anaphylaxis in 1 patient, isolated seizure in 1 patient, and seizure and cerebral edema in 1 patient.

Discussion SIACI of mannitol followed by Cetuximab (up to 250 mg/m²) for recurrent malignant glioma is safe and well tolerated. A Phase I/II trial is currently underway to determine the efficacy of SIACI of cetuximab in patients with high-grade glioma.

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