Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002781
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Boron Neutron Capture Therapy in Treating Patients With Stage III Melanoma
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PROCEDURES FOR BNCT PHASE-I STUDY OF MELANOMA IN THE EXTREMITIES
Status:
UNKNOWN
Status Verified Date:
2000-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma
PURPOSE Phase I trial to study the effectiveness of boron neuron capture therapy in treating patients with stage III melanoma
Detailed Description:
OBJECTIVES I Estimate the maximum tolerated dose of neutron irradiation that can be given in combination with borophenylalanine-fructose complex BPA-F in patients with stage III melanoma II Evaluate the safety of this regimen III Evaluate tumor response to this regimen
OUTLINE This is a dose-finding study Patients receive a test dose of borophenylalanine-fructose complex BPA-F for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration Later a treatment dose of BPA-F over 1 hour is followed by neutron irradiation Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site Patients are followed monthly for 12 months then every 3-6 months as needed
PROJECTED ACCRUAL Approximately 15 patients will be entered
OUTLINE This is a dose-finding study Patients receive a test dose of borophenylalanine-fructose complex BPA-F for biodistribution studies and undergo punch biopses of tumor and normal tissue to measure B-10 concentration Later a treatment dose of BPA-F over 1 hour is followed by neutron irradiation Groups of 3 patients receive escalated doses of neutron irradiation until the maximum tolerated dose is determined Patients who complete protocol treatment and continue to meet the eligibility criteria may re-enter the study provided at least 6 months has elapsed since the completion of prior therapy and the field boundary for the new irradiation site is seperated from the boundary of the previously irradiated site Patients are followed monthly for 12 months then every 3-6 months as needed
PROJECTED ACCRUAL Approximately 15 patients will be entered
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 |
|---|---|---|---|
| NCI-V96-0907 | None | None | None |
| NEDH-961207015 | None | None | None |