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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Head and Neck Cancer, Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Boron uptake ratio in tumor vs normal tissue

Safety Issue:

No

Principal Investigator

Wolfgang Sauerwein, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitaetsklinikum Essen

Authority:

European Union: European Medicines Agency

Study ID:

EORTC-11001

NCT ID:

NCT00062348

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Head and Neck Cancer
  • Metastatic 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
  • 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
  • Thyroid Neoplasms
  • Colorectal Neoplasms
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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