Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085059
Status:
TERMINATED
Last Update Posted:
2012-07-18
First Post:
2004-06-10
Brief Title:
Boron Neutron Capture Therapy Using Boronophenylalanine-Fructose Complex in Treating Patients With Metastatic Melanoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Early Phase II Study On BNCT In Metastatic Malignant Melanoma Using The Boron Carrier BPA
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
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 using boronophenylalanine-fructose complex may kill tumor cells without harming normal tissue
PURPOSE This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma
PURPOSE This phase II trial is studying how well boron neutron capture therapy using boronophenylalanine-fructose complex works in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma
Determine the objective local response in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the duration of local response and time to local progression in patients treated with this regimen
Determine the dose-response relationship at the per-lesion level in patients treated with this regimen
Determine the safety of this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2
Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter In the event of disease progression patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 16-24 patients will be accrued for this study
Primary
Determine the therapeutic activity and efficacy of boron neutron capture therapy using boronophenylalanine-fructose complex in patients with metastatic melanoma
Determine the objective local response in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the duration of local response and time to local progression in patients treated with this regimen
Determine the dose-response relationship at the per-lesion level in patients treated with this regimen
Determine the safety of this regimen in these patients
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label study
Patients receive boronophenylalanine-fructose complex IV over 90 minutes followed by boron neutron capture therapy on days 1 and 2
Patients are followed at 1 and 6 weeks and then every 8 weeks thereafter In the event of disease progression patients are followed every 3 months for survival
PROJECTED ACCRUAL A total of 16-24 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-11011 | None | None | None |