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Clinical Trial
. 2016 Jul;128(3):405-15.
doi: 10.1007/s11060-016-2099-8. Epub 2016 Mar 5.

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

Shamik Chakraborty  1   2 , Christopher G Filippi  2 , Tamika Wong  1 , Ashley Ray  1 , Sherese Fralin  1 , A John Tsiouris  3 , Bidyut Praminick  2 , Alexis Demopoulos  1   2 , Heather J McCrea  3 , Imithri Bodhinayake  1 , Rafael Ortiz  1   2 , David J Langer  1   2 , John A Boockvar  4   5   6
Affiliations
Clinical Trial

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

Shamik Chakraborty et al. J Neurooncol. 2016 Jul.

Erratum in

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/m(2) and dose escalation was done to 250 mg/m(2). 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/m(2) 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/m(2)) 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.

Keywords: Brain neoplasm; Cetuximab; Glioma; Intraarterial infusion; Mannitol.

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