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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Completed

Phase 1

Conditions

Metastatic Cancer

Head and Neck Cancer

Colorectal Cancer

Treatments

Drug: sodium borocaptate

Procedure: conventional surgery

Drug: boronophenylalanine-fructose complex

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00062348

EORTC-11001

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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