Neoplasms

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Gland and Hormone Related Diseases

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Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

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Thyroid Neoplasms

Thyroid Diseases

Head and Neck Neoplasms

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Laryngeal Diseases

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Hematinics

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Boron

Cola

boronophenylalanine-fructose complex

sodium borocaptate

conventional surgery

Wolfgang Sauerwein, MD, PhD

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.

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

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

European Organisation for Research and Treatment of Cancer - EORTC

Nervous System Diseases

Glioblastoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Gliosarcoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

adjuvant therapy

RATIONALE: Boron neutron capture therapy may selectively kill tumor cells without harming normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of boron neutron capture therapy following surgery in treating patients with glioblastoma multiforme removed during surgery.

OBJECTIVES:

* Determine systemic and local toxicity of borocaptate sodium with boron neutron capture therapy (BNCT) following craniotomy with gross total resection in patients with glioblastoma multiforme.
* Determine the qualitative and quantitative dose-limiting toxicity and maximum tolerated dose of this regimen in these patients.
* Determine the maximum tolerated radiation dose of BNCT in cranial localization to healthy tissues in these patients under defined conditions.

OUTLINE: This is a dose escalation, multicenter study.

Within 6 weeks of surgery, patients receive borocaptate sodium followed 12-18 hours later by neutron irradiation. Treatment repeats daily for 4 days.

Cohorts of 3-9 patients receive escalating doses of neutron irradiation. The maximum tolerated dose is defined as the dose preceding that at which 3 or more patients experience dose limiting toxicity.

Patients are followed weekly for 4 weeks, monthly for 2 months, every 6 weeks for 15 months and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 30-36 patients will be accrued for this study.

Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery

Postoperative Treatment of Glioblastoma With BNCT at the Petten Irradiation Facility

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT00062348	Colorectal Canc... Head and Neck C... Metastatic Canc...	boronophenylala... sodium borocapt... conventional su...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery	NCT00004015	Brain and Centr...	sodium borocapt... adjuvant therap...	50 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Boron Neutron Capture Therapy Following Surgery in Treating Patients With Glioblastoma Multiforme Removed During Surgery	NCT00004015	Brain and Centr...	sodium borocapt... adjuvant therap...	50 Years -	European Organisation for Research and Treatment of Cancer - EORTC

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