Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062348
Status:
COMPLETED
Last Update Posted:
2012-01-20
First Post:
2003-06-05
Brief Title:
Boronophenylalanine-Fructose Complex BPA-F andor Sodium Borocaptate BSH Followed By Surgery in Treating Patients With Thyroid Cancer Head and Neck Cancer or Liver Metastases
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
Status:
COMPLETED
Status Verified Date:
2012-01
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 Diagnostic procedures using boronophenylalanine-fructose complex BPA-F andor sodium borocaptate BSH to detect the presence of boron in tumor cells may help determine whether patients who have thyroid cancer head and neck cancer or liver metastases may benefit from boron neutron capture therapy
PURPOSE This phase I trial is studying the side effects of giving BPA-F andor BSH before surgery to detect boron uptake in tissues of patients with primary metastatic or recurrent thyroid cancer head and neck cancer or liver metastases from colorectal cancer
PURPOSE This phase I trial is studying the side effects of giving BPA-F andor BSH before surgery to detect boron uptake in tissues of patients with primary metastatic or recurrent thyroid cancer head and neck cancer or liver metastases from colorectal cancer
Detailed Description:
OBJECTIVES
Identify additional solid tumors that may benefit from boron neutron capture therapy
Determine the boron concentration in the tumor surrounding tissues and blood of patients with operable thyroid cancer squamous cell cancer of the head and neck or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex BPA-F andor sodium borocaptate BSH before surgical resection
Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients
Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients
OUTLINE This is a multicenter study Patients are sequentially assigned to 1 of 3 treatment groups
Group I Patients receive boronophenylalanine-fructose complex BPA-F IV over 1 hour Two hours later patients undergo surgical resection
Group II Patients receive sodium borocaptate BSH IV over 1 hour Twelve hours later patients undergo surgical resection
Group III Patients receive BSH IV over 1 hour administered 12 hours prior to surgery and BPA-F IV over 1 hour administered 2 hours prior to surgery Patients then undergo surgical resection
During the planned surgery tissue samples from the tumor and surrounding tissues are collected
Patients are followed on days 1 and 5 and then at 4 weeks
PROJECTED ACCRUAL A maximum of 27 patients will be accrued for this study
Identify additional solid tumors that may benefit from boron neutron capture therapy
Determine the boron concentration in the tumor surrounding tissues and blood of patients with operable thyroid cancer squamous cell cancer of the head and neck or liver metastases secondary to colorectal adenocarcinoma who receive boronophenylalanine-fructose complex BPA-F andor sodium borocaptate BSH before surgical resection
Determine the feasibility of using these drugs to obtain a favorable absolute boron-10 concentration in the tumor and optimal tumor-to-blood and tumor-to-healthy tissue boron-10 rates in these patients
Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients
OUTLINE This is a multicenter study Patients are sequentially assigned to 1 of 3 treatment groups
Group I Patients receive boronophenylalanine-fructose complex BPA-F IV over 1 hour Two hours later patients undergo surgical resection
Group II Patients receive sodium borocaptate BSH IV over 1 hour Twelve hours later patients undergo surgical resection
Group III Patients receive BSH IV over 1 hour administered 12 hours prior to surgery and BPA-F IV over 1 hour administered 2 hours prior to surgery Patients then undergo surgical resection
During the planned surgery tissue samples from the tumor and surrounding tissues are collected
Patients are followed on days 1 and 5 and then at 4 weeks
PROJECTED ACCRUAL A maximum of 27 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-11001 | None | None | None |