Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment Head and Neck Tumors
|Head and Neck Cancer||Radiation: boronophenylalanine-based BNCT||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Inoperable and Irradiated Head and Neck Tumors: A Feasibility Study|
- treatment response [ Time Frame: 1 year ]
- time to progression [ Time Frame: 2 years ]
- safety [ Time Frame: 2 years ]
|Study Start Date:||December 2003|
|Study Completion Date:||January 2012|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Radiation: boronophenylalanine-based BNCT
Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II trial to determine the value of BNCT in the treatment of inoperable, irradiated, locally advanced cancers of the head and neck region. An attempt to perform 18F-labeled boronophenylalanine (18F-BPA) SPECT or PET imaging will be made before BNCT. Patients whose tumor uptake is >2.5 times that of the corresponding normal head and neck tissue will be enrolled, and treated with a single fraction BPA-based BNCT twice, 3 to 5 weeks apart. Another 18F-BPA SPECT or PET study may be performed 1 to 3 months after BNCT to determine the SPECT/PET response.
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.
Prior to BNCT, BPA is infused as a fructose complex (l-BPA-F) into a peripheral vein over 2 hours. Blood samples will be taken for monitoring whole blood boron concentration before starting the BPA infusion, and thereafter at 20 to 40 minute intervals during the infusion, following infusion, and after delivering neutron irradiation. The blood samples will be analyzed for blood boron concentration to estimate the average blood boron concentration during neutron irradiation.
All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00114790
|Department of Oncology, Helsinki University Central Hospital|
|Helsinki, Finland, FIN-00029|
|Principal Investigator:||Heikki T Joensuu, M.D., prof.||Helsinki University Central Hospital|