Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme
This is a single BNCT-facility, non-randomized, non-comparative, prospective, open-label,
phase I/II trial to determine the value of BNCT in the treatment of subjects who have
undergone surgery for glioblastoma, but glioblastoma has not been treated with radiation
therapy or chemotherapy. The neutron irradiation site is the FiR 1 reactor site, located at
Otaniemi, Espoo, Finland, about 6 kilometers from the Helsinki University Central Hospital,
Helsinki, where patient evaluation and post-irradiation care will take place.
BPA is infused as a fructose complex (BPA-F) into a peripheral vein over 2 hours prior to
neutron irradiation. Blood samples will be taken before starting the BPA infusion, and
thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after
delivering neutron irradiation to monitor the blood boron concentration. The blood samples
will be analyzed for boron to estimate the average blood boron level during neutron
irradiation. The first 12 patients are treated using a BPA dose of 290 mg/kg, following
which the dose of BPA is increased stepwise to 500 mg/kg, provided that unacceptable
toxicity will not occur.
All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heikki Joensuu, M.D., prof.
Helsinki University Central Hospital
Finland: Finnish Medicines Agency