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
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
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.
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.
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