Boron Neutron Capture Therapy (BNCT) as Treatment of Glioblastoma
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme|
- safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- tumor response [ Time Frame: one year ] [ Designated as safety issue: No ]
- effect on brain tissue [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 1999|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Active treatment arm.
Boronophenylalanine is infused into a peripheral vein prior to neutron irradiation.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115453
|Department of Oncology, Helsinki University Central Hospital|
|Helsinki, Finland, FIN-00029|
|Principal Investigator:||Heikki Joensuu, M.D., prof.||Helsinki University Central Hospital|