Pharmacokinetics of Na2B12H11SH (BSH) in patients with malignant brain tumours as prerequisite for a phase I clinical trial of boron neutron capture

The disposition of Na2B12H11SH (BSH) in patients with malignant glioma has been investigated, in preparation for a Phase I clinical trial of boron neutron capture therapy. BSH was found to possess a linear disposition over the dosage interval investigated (up to 75 mg/kg). A bi-phasic blood pharmacokinetics was observed. Tumour-to-blood ratios showed variations between patients between 0.08 and 5.1. The data allow the definition of amount of BSH and timing of infusion for a Phase I clinical trial protocol

Radiologic findings in patients treated with boron neutron capture therapy for glioblastoma multiforme within EORTC trial 11961

PURPOSE: To assess the occurrence and development of cerebral radiologic changes (cerebral atrophy and white matter lesions) in patients treated with boron neutron capture therapy (BNCT) for primary supratentorial glioblastoma multiforme within the European Organization for Research and Treatment of Cancer (EORTC) trial 11961. METHODS AND MATERIALS: Magnetic resonance imaging (MRI) scans were performed before and after surgery and at 1 week and 2, 4.5, 6, 9, 12, 15, and 18 months after BNCT. For the current study, MRI scans of all assessable patients were analyzed, with emphasis on cerebral atrophy and white matter abnormalities. RESULTS: Twenty-six patients had been treated with BNCT according to the EORTC trial 11961, of whom 24 were assessable for the current study. The development of possible BNCT-related cerebral changes was observed in 12 patients (50%), 10 of whom had cerebral atrophy (42%) and 10 white matter changes (42%) after a median interval of 7.5 and 4.5 months, respectively. CONCLUSION: In this study, cerebral radiologic changes appeared in 50% of patients within the first year after BNCT. Although a clear correlation between the BNCT dose and the development of cerebral changes could not be demonstrated, a relationship between the occurrence of these radiologic abnormalities and BNCT seems likel