A Phase 1 Trial of Intravenous Boronophenylalanine-Fructose Complex in Patients with Glioblastoma Multiforme

Abstract

Seven patients with glioblastoma multiforme received 2-hour intravenous infusions of p-boronophenylalanine (BPA) prior to craniotomy. The BPA was solubilized for injection by complexation with fructose. Administered BPA doses were 100mg BPA/kg (n=1), 130 mg BPA/kg (n=5) and 170 mg BPA/kg (n=1). The boron concentration in blood was proportional to the administered dose. The boron concentrations in scalp were 1-2 times higher than the corresponding boron concentration in the blood. The boron concentrations in the tumor (range, 11–26g 10B/g) were from 1–4 times the corresponding levels in the blood.