Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	18 and over	Other	EORTC-11001 NCT00062348

Objectives

1. Identify additional solid tumors that may benefit from boron neutron capture therapy.
2. 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.
3. 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.
4. Determine the qualitative and quantitative toxicity of combined BPA-F and BSH administration in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A maximum of 27 patients will be accrued for this study.

Outcomes

Boron uptake ratio in tumor vs normal tissue

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

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.

Bendel P, Wittig A, Basilico F, et al.: Metabolism of borono-phenylalanine-fructose complex (BPA-fr) and borocaptate sodium (BSH) in cancer patients-Results from EORTC trial 11001. J Pharm Biomed Anal : , 2009.[PUBMED Abstract]

Wittig A, Collette L, Moss R, et al.: Early clinical trial concept for boron neutron capture therapy: a critical assessment of the EORTC trial 11001. Appl Radiat Isot 67 (7-8 Suppl): S59-62, 2009.[PUBMED Abstract]

Wittig A, Collette L, Appelman K, et al.: EORTC trial 11001: distribution of two (10)B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med : , 2009.[PUBMED Abstract]

Wittig A, Malago M, Collette L, et al.: Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int J Cancer 122 (5): 1164-71, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Wolfgang Sauerwein, MD, PhD, Study coordinator		Ph: 49-201-723-2052 Email: w.sauerwein@uni-essen.de

Germany
	Essen
	Universitaetsklinikum Essen
		Contact Person	Ph:  49-201-72-311

Registry Information
Official Title		10B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
Trial Start Date		2003-04-29
Registered in ClinicalTrials.gov		NCT00062348
Date Submitted to PDQ		2003-05-06
Information Last Verified		2009-06-14

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