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

Study Overview
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Brief Summary
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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
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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.

Official Title
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B-Uptake In Different Tumours Using The Boron Compounds BSH And BPA

Conditions
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Colorectal Cancer, Head and Neck Cancer, Metastatic Cancer

Intervention / Treatment
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* Drug: boronophenylalanine-fructose complex
* Drug: sodium borocaptate
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: boronophenylalanine-fructose complex|nan|
|Drug: sodium borocaptate|nan|
|Procedure: conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boron uptake ratio in tumor vs normal tissue |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity measured by NCI-CTC v2.0 up to 28 days after injections |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent salivary gland cancer, 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, 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