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

January 19, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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) 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

Enrollment (Anticipated)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, D-45122
        • Universitaetsklinikum Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed solid tumor of 1 of the following malignant tumor types:

    • Squamous cell cancer of the head and neck
    • Thyroid cancer
    • Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver
  • Operable disease for which a surgical excision is planned
  • Primary, metastatic, or locally recurrent disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2.5 times ULN
  • AST and ALT no greater than 2.5 times ULN
  • No other severe liver function impairment

Renal

  • Creatinine normal
  • BUN normal

Cardiovascular

  • No congestive heart failure
  • No angina pectoris
  • No recent coronary artery disease
  • No uncontrolled arrhythmias
  • No conduction defects
  • No other severe heart disease

Pulmonary

  • No severe obstructive or restrictive lung disease

Gastrointestinal

  • No severe gastrointestinal disease
  • No active peptic ulcer disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No pre-existing serious mental or organic brain disease (e.g., epilepsy)
  • No history of phenylketonuria (only in the case of BPA administration)
  • No severe allergic disease requiring continuous medication
  • No other concurrent severe disease
  • No uncontrolled endocrine disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 3 months since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the malignant site

Surgery

  • See Disease Characteristics

Other

  • Recovered from prior antitumor therapy (excluding alopecia)
  • No concurrent anticancer treatment or agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Boron uptake ratio in tumor vs normal tissue

Secondary Outcome Measures

Outcome Measure
Toxicity measured by NCI-CTC v2.0 up to 28 days after injections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Wolfgang Sauerwein, MD, PhD, Universitaetsklinikum Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 5, 2003

First Submitted That Met QC Criteria

June 5, 2003

First Posted (Estimate)

June 6, 2003

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-11001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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