Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004015
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
1999-11-01
Brief Title:
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility
Status:
COMPLETED
Status Verified Date:
2012-07
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:
RATIONALE Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue
PURPOSE This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery
PURPOSE This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery
Detailed Description:
OBJECTIVES
Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy BNCT following craniotomy with gross total resection in patients with glioblastoma multiforme
Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients
Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions
OUTLINE This is a dose escalation multicenter study
Within 6 weeks of surgery patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation Treatment repeats daily for 4 days
Cohorts of 3-9 patients receive escalating doses of neutron irradiation The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity
Patients are followed weekly for 4 weeks monthly for 2 months every 6 weeks for 15 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 30-36 patients will be accrued for this study
Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy BNCT following craniotomy with gross total resection in patients with glioblastoma multiforme
Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients
Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions
OUTLINE This is a dose escalation multicenter study
Within 6 weeks of surgery patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation Treatment repeats daily for 4 days
Cohorts of 3-9 patients receive escalating doses of neutron irradiation The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity
Patients are followed weekly for 4 weeks monthly for 2 months every 6 weeks for 15 months and then every 3 months thereafter
PROJECTED ACCRUAL Approximately 30-36 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-11961 | None | None | None |