Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059800
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2003-05-06
Brief Title:
Boron Neutron Capture Therapy in Treating Patients With Melanoma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial For Neutron Capture Therapy In Melanoma
Status:
COMPLETED
Status Verified Date:
2005-12
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 Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma
PURPOSE Phase II trial to study the effectiveness of boron neutron capture therapy in treating patients who have melanoma
Detailed Description:
OBJECTIVES
Determine the clinical response by serial objective measurements in patients with melanoma treated with boron neutron capture therapy
Determine the time course uniformity and severity of acute dermal reactions in patients treated with this regimen
Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE Patients are stratified according to tumor size no greater than 15 cc vs greater than 15 cc
Patients undergo boron neutron capture therapy
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 3 years
Determine the clinical response by serial objective measurements in patients with melanoma treated with boron neutron capture therapy
Determine the time course uniformity and severity of acute dermal reactions in patients treated with this regimen
Determine the late dermal reactions in patients who are followed for at least 6 months after treatment with this regimen
Determine the pharmacokinetics of this regimen in these patients
OUTLINE Patients are stratified according to tumor size no greater than 15 cc vs greater than 15 cc
Patients undergo boron neutron capture therapy
Patients are followed for 3 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000287207 | REGISTRY | None | None |
| BIDMC-2001-P-001946 | Registry Identifier | PDQ Physician Data Query | None |