BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy
This is a single BNCT-facility, non-randomized, non-comparative, prospective, open-label,
phase I/II study to determine the value of BNCT in the treatment of inoperable, irradiated,
progressing anaplastic astrocytomas or glioblastomas following conventional radiation
therapy. 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. A minimum tumor dose of 17 Gy (W) is given while limiting the normal brain
maximum peak dose to 8 Gy (W), and the average normal brain dose to 6 Gy (W). The first 10
patients will be given BPA 290 mg/kg, following which the BPA dose will be escalated in
cohorts of 3 subjects gradually up to 450 mg/kg, provided that protocol-specified
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 T Joensuu, M.D., prof.
Helsinki University Central Hospital
Finland: Finnish Medicines Agency