Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039572
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2002-06-06
Brief Title:
Boron Neutron Capture Therapy in Treating Patients With Glioblastoma Multiforme or Melanoma Metastatic to the Brain
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial For Neutron Capture Therapy In Glioblastoma Multiforme And Intracranial Melanoma
Status:
COMPLETED
Status Verified Date:
2002-07
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 Radiation therapy such as boron neutron capture therapy may kill tumor cells without harming normal tissue
PURPOSE Phase III trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain
PURPOSE Phase III trial to study the effectiveness of boron neutron capture therapy in treating patients who have glioblastoma multiforme or melanoma metastatic to the brain
Detailed Description:
OBJECTIVES
Determine the time course uniformity and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex BPA-f followed by cranial neutron irradiation using a new fission converter beam facility
Determine the maximum tolerated dose of cranial neutron capture therapy in these patients
Determine through serial objective measurements the clinical response in patients treated with this therapy
Determine the pharmacokinetics of BPA-f in these patients
OUTLINE This is a dose-escalation study of cranial neutron capture therapy NCT
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2
Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
Patients are followed at 1 2 4 6 9 and 12 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 16 patients will be accrued for this study within 2 years
Determine the time course uniformity and severity of acute and chronic normal tissue reactions in patients with glioblastoma multiforme or intracranial melanoma treated with boronophenylalanine-fructose complex BPA-f followed by cranial neutron irradiation using a new fission converter beam facility
Determine the maximum tolerated dose of cranial neutron capture therapy in these patients
Determine through serial objective measurements the clinical response in patients treated with this therapy
Determine the pharmacokinetics of BPA-f in these patients
OUTLINE This is a dose-escalation study of cranial neutron capture therapy NCT
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by cranial NCT on days 1 and 2
Cohorts of 3-6 patients receive escalating doses of NCT until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the MTD
Patients are followed at 1 2 4 6 9 and 12 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 16 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V02-1702 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069398 | REGISTRY | None | None |
| NEDH-E-010284FB | None | None | None |