Boronophenylalanine-Fructose Complex (BPA-F) and/or Sodium Borocaptate (BSH) Followed By Surgery in Treating Patients With Thyroid Cancer, Head and Neck Cancer, or Liver Metastases
|ClinicalTrials.gov Identifier: NCT00062348|
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : January 20, 2012
RATIONALE: Diagnostic procedures using boronophenylalanine-fructose complex (BPA-F) and/or 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 and/or 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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Head and Neck Cancer Metastatic Cancer||Drug: boronophenylalanine-fructose complex Drug: sodium borocaptate Procedure: conventional surgery||Phase 1|
- 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) and/or 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Masking:||None (Open Label)|
|Official Title:||B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||December 2007|
- Boron uptake ratio in tumor vs normal tissue
- Toxicity measured by NCI-CTC v2.0 up to 28 days after injections
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062348
|Essen, Germany, D-45122|
|Study Chair:||Wolfgang Sauerwein, MD, PhD||Universitaetsklinikum Essen|