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

Colorectal Cancer Clinical Trial

Official title: B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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) 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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

• NCT number: NCT00062348
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Completed
• Phase: Phase 1
• Start date: April 2003