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

This study has been completed.
Sponsor:
Information provided by:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00062348
First received: June 5, 2003
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Colorectal Cancer
Head and Neck Cancer
Metastatic Cancer
Drug: boronophenylalanine-fructose complex
Drug: sodium borocaptate
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Boron uptake ratio in tumor vs normal tissue [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity measured by NCI-CTC v2.0 up to 28 days after injections [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: April 2003
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062348

Locations
Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Wolfgang Sauerwein, MD, PhD Universitaetsklinikum Essen
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00062348     History of Changes
Other Study ID Numbers: EORTC-11001, EORTC-11001
Study First Received: June 5, 2003
Last Updated: January 19, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the nasopharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the nasopharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
untreated metastatic squamous neck cancer with occult primary
recurrent thyroid cancer
stage IV follicular thyroid cancer
stage IV papillary thyroid cancer
stage IVA colon cancer
stage IVB colon cancer
recurrent colon cancer
adenocarcinoma of the colon
recurrent rectal cancer
stage IVA rectal cancer
stage IVB rectal cancer
adenocarcinoma of the rectum
anaplastic thyroid cancer
insular thyroid cancer
thyroid gland medullary carcinoma
liver metastases
stage I squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Thyroid Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Endocrine Gland Neoplasms
Neoplasms by Site
Endocrine System Diseases
Thyroid Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014