BNCT to Treat Glioma That Has Progressed Following Radiotherapy
|Glioblastoma Anaplastic Astrocytoma||Radiation: Bononophenylalanine (BPA)-based BNCT||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||BPA-Mediated Boron Neutron Capture Therapy (BNCT) in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy|
- safety [ Time Frame: 3 years ]
- survival [ Time Frame: 3 years ]
- adverse effects of BNCT [ Time Frame: 3 years ]
- quality-of-life [ Time Frame: 3 years ]
|Study Start Date:||March 2001|
|Study Completion Date:||January 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active treatment arm.
Radiation: Bononophenylalanine (BPA)-based BNCT
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 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115440
|Department of Oncology, Helsinki University Central Hospital|
|Helsinki, Finland, FIN-00029|
|Principal Investigator:||Heikki T Joensuu, M.D., prof.||Helsinki University Central Hospital|