B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
- 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
- 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
- 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
During the planned surgery, tissue samples from the tumor and surrounding tissues are
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.
Masking: Open Label, Primary Purpose: Treatment
Boron uptake ratio in tumor vs normal tissue
Wolfgang Sauerwein, MD, PhD
European Union: European Medicines Agency