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 - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer - EORTC
Information provided by:	European Organization for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:	NCT00062348

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 I

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:

MedlinePlus related topics: Cancer Colorectal Cancer Head and Neck Cancer Thyroid Cancer Thyroid Diseases

Drug Information available for: Fructose Thyroid

U.S. FDA Resources

Further study details as provided by European Organization 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

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

Locations

Germany
Universitaetsklinikum Essen
Essen, Germany, D-45122

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer - EORTC

Investigators

Study Chair:

Wolfgang Sauerwein, MD, PhD

Universitaetsklinikum Essen

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 Feb 16; [Epub ahead of print]

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. 2009 Aug 22; [Epub ahead of print]

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 (10)B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med. 2009 Jul 10; [Epub ahead of print]

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 Mar 25; [Epub ahead of print]

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 (10)B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC trial 11001). Int J Cancer. 2007 Nov 5; [Epub ahead of print]

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 Organization 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 February 09, 2012