Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115440
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2005-06-22
Brief Title:
BNCT to Treat Glioma That Has Progressed Following Radiotherapy
Sponsor:
Boneca Corporation
Organization:
Boneca Corporation
Study Overview
Official Title:
BPA-Mediated Boron Neutron Capture Therapy BNCT in the Treatment of Glioblastoma or Anaplastic Astrocytoma Progressing After Conventional External Beam Radiotherapy
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 which 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 once The study hypothesis is that anaplastic astrocytomas and glioblastomas that have recurred following conventional radiotherapy might accumulate the boron carrier compound and might respond to BNCT
Detailed Description:
This is a single BNCT-facility non-randomized non-comparative prospective open-label phase III 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 mgkg following which the BPA dose will be escalated in cohorts of 3 subjects gradually up to 450 mgkg provided that protocol-specified 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 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 mgkg following which the BPA dose will be escalated in cohorts of 3 subjects gradually up to 450 mgkg provided that protocol-specified 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BNCT P-03 | None | None | None |