Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) Combined With Anti-erbB1 Antibody Therapy in the Treatment of Locally Recurred Head and Neck Cancer: A Phase I/II Study.
This is a single-center, non-randomized, non-comparative, open-label, phase I/II trial to
determine safety and efficacy of BNCT in the treatment of nonoperable, irradiated, locally
advanced cancers of the head and neck region. Patients will be treated with a
single-fraction boronophenylalanine (BPA)-based BNCT. All patients will be evaluated for
response using CT or magnetic resonance imaging (MRI).
Neutron irradiation will first be planned based on the available tumor imaging examinations,
following which the head and body position will be determined for irradiation, and head
fixation will be prepared and tested. On the irradiation day 400 mg/m2 L-BPA-F will be
infused intravenously over 2 hours. Cetuximab doses will be administered following
completion of BNCT. The cetuximab doses will be escalated in cohorts of 3 patients.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heikki Joensuu, MD
Department of Oncology, Helsinki University Central Hospital
Finland: Finnish Medicines Agency