Clinical trial NCT00062348: 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
Official title: B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Head and Neck Cancer
Metastatic Cancer
Keywords: 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
stage I squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the nasopharynx
stage I squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the nasopharynx
stage II squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the nasopharynx
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I papillary thyroid cancer
stage II papillary thyroid cancer
stage III papillary thyroid cancer
stage I follicular thyroid cancer
stage II follicular thyroid cancer
stage III follicular thyroid cancer
recurrent metastatic squamous neck cancer with occult primary
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
tongue cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
First posted: 2003-06-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Boron uptake ratio in tumor vs normal tissue
Secondary outcomes:
measure: Toxicity measured by NCI-CTC v2.0 up to 28 days after injections
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
Study officials:
affiliation: Universitaetsklinikum Essen
name: Wolfgang Sauerwein, MD, PhD
role: STUDY_CHAIR
References:
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.2011.02.018. Epub 2011 Feb 16.
citation: 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/j.jpba.2009.08.018. Epub 2009 Aug 22.
citation: Wittig A, Collette L, Appelman K, Buhrmann S, Jackel MC, Jockel KH, Schmid KW, Ortmann U, Moss R, Sauerwein WAG. EORTC trial 11001: distribution of two 10B-compounds in patients with squamous cell carcinoma of head and neck, a translational research/phase 1 trial. J Cell Mol Med. 2009 Aug;13(8B):1653-1665. doi: 10.1111/j.1582-4934.2009.00856.x. Epub 2009 Jul 10.
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 25.
citation: Wittig A, Malago M, Collette L, Huiskamp R, Buhrmann S, Nievaart V, Kaiser GM, Jockel KH, Schmid KW, Ortmann U, Sauerwein WA. 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. 2008 Mar 1;122(5):1164-71. doi: 10.1002/ijc.23224.