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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062348
• Other study ID #: EORTC-11001
• Secondary ID: EORTC-11001
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2003
• Last updated: January 19, 2012
• Start date: April 2003

Study information

• Verified date: January 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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

Intervention

Drug:
• boronophenylalanine-fructose complex

• sodium borocaptate

Procedure:
• conventional surgery

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Essen	Essen

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Bendel P, Wittig A, Basilico F, Mauri PL, Sauerwein W. Metabolism of borono-phenylalanine-fructose complex (BPA-fr) and borocaptate sodium (BSH) in cancer patients--results from EORTC trial 11001. J Pharm Biomed Anal. 2010 Jan 5;51(1):284-7. doi: 10.1016/ — View Citation

Wittig A, Collette L, Appelman K, Bührmann S, Jäckel MC, Jöckel KH, Schmid KW, Ortmann U, Moss R, Sauerwein WA. EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase — View Citation

Wittig A, Collette L, Moss R, Sauerwein WA. Early clinical trial concept for boron neutron capture therapy: a critical assessment of the EORTC trial 11001. Appl Radiat Isot. 2009 Jul;67(7-8 Suppl):S59-62. doi: 10.1016/j.apradiso.2009.03.012. Epub 2009 Mar — View Citation

Wittig A, Malago M, Collette L, Huiskamp R, Bührmann S, Nievaart V, Kaiser GM, Jöckel KH, Schmid KW, Ortmann U, Sauerwein WA. Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron ca — View Citation

Wittig A, Sheu-Grabellus SY, Collette L, Moss R, Brualla L, Sauerwein W. BPA uptake does not correlate with LAT1 and Ki67 expressions in tumor samples (results of EORTC trial 11001). Appl Radiat Isot. 2011 Dec;69(12):1807-12. doi: 10.1016/j.apradiso.2011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boron uptake ratio in tumor vs normal tissue			No
Secondary	Toxicity measured by NCI-CTC v2.0 up to 28 days after injections			Yes