Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115453
Status:
TERMINATED
Last Update Posted:
2008-08-18
First Post:
2005-06-22
Brief Title:
Boron Neutron Capture Therapy BNCT as Treatment of Glioblastoma
Sponsor:
Boneca Corporation
Organization:
Boneca Corporation
Study Overview
Official Title:
Boron Neutron Capture Therapy in the Treatment of Glioblastoma Multiforme
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Boron Neutron Capture Therapy BNCT is an experimental radiation therapy technique that is based on the principle of irradiating boron atoms with neutrons When neutrons have relatively low energy boron atoms that have been targeted to cancerous tissue using a suitable boron carrier an amino acid derivative called BPA boronophenylalanine will capture the neutrons As a result from the neutron capture the boron atoms will split into two producing helium and lithium ions The helium and lithium ions in turn have only a short pathlength in tissue about 5 micrometers and will deposit their cell damaging effect mainly within the tumor provided that the boron carrier BPA has accumulated in the tumor In practice the study participants will receive BPA as an approximately 2-hour intravenous infusion following which the tumor is irradiated with low energy epithermal neutrons obtained from a nuclear reactor at the BNCT facility BNCT requires careful radiation dose planning but neutron irradiation will last approximately only for one hour In this study BNCT is given only once The study hypothesis is that glioblastoma tissue may accumulate the boron carrier compound and glioblastoma might respond to BNCT
Detailed Description:
This is a single BNCT-facility non-randomized non-comparative prospective open-label phase III 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 mgkg following which the dose of BPA is increased stepwise to 500 mgkg provided that unacceptable toxicity will not occur
All patients will be evaluated for response using CT or magnetic resonance imaging MRI
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 mgkg following which the dose of BPA is increased stepwise to 500 mgkg provided that unacceptable toxicity will not occur
All patients will be evaluated for response using CT or magnetic resonance imaging MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None