Clinical phase-I study of Na[sub 2]B[sub 12]H[sub 11]SH (BSH) in patients with malignant glioma as precondition for boron neutron capture therapy (BNCT)
- Univ. Hospital, Hamburg (Germany)
- Univ. of Bremen (Germany)
- Netherlands Energy Research Foundation, Petten (Netherlands)
Within the European collaboration on boron neutron capture therapy (BNCT), a clinical Phase I study is being carried out to establish BNCT as an alternative treatment modality for malignant glioma (WHO III/IV). Data about the pharmacokinetics, biodistribution and toxicity of the boron compound Na[sub 2]B[sub 12]H[sub 11]SH (BSH) are of great importance to avoid radiation damage of healthy tissue and to deliver a sufficient radiation dose. Twenty four patients suffering from a glioblastoma multiforme entered the study to date, infused with a maximum concentration of up to 50 mg BSH/kg. Boron concentration measurements in tissues, urine, and blood were carried out, using inductively coupled plasma-atomic spectroscopy (ICP-AES) and quantitative neutron capture radiography (QNCR). A cross-calibration of these determination techniques was carried out. In tumor tissue, confirmed by histopathology of small biopsies, they found a consistently high but heterogeneous boron uptake. Necrotic parts contain much lower amounts of boron; normal brain tissue has shown no significant uptake. In skin, bone, muscle, and dura mater only small amounts of boron were found. In blood samples, they found biphasic kinetics, but with variations of the half-lives from patient to patient. The compound is mainly excreted through the urine, but an additional entero-hapatic pathway can be demonstrated. Systematic investigations revealed no toxic side effect of the intravenously administered BSH. Comparable data were obtained by using ICP-AES and QNCR for boron concentration measurements. Taking into account the radiobiological considerations of the neutron beam source, they found promising facts that BNCT could be a useful irradiation method for highly malignant brain tumors. Favorable amounts of the boron compound BSH were found in tumor tissue, whereas healthy brain tissue has shown no significant uptake. 16 refs., 8 figs., 2 tabs.
- OSTI ID:
- 6888449
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics; (United States), Vol. 28:5; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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62 RADIOLOGY AND NUCLEAR MEDICINE
BORON COMPOUNDS
TISSUE DISTRIBUTION
TOXICITY
GLIOMAS
NEUTRON CAPTURE THERAPY
DISEASES
DISTRIBUTION
MEDICINE
NEOPLASMS
NEUTRON THERAPY
NUCLEAR MEDICINE
RADIOLOGY
RADIOTHERAPY
THERAPY
560300* - Chemicals Metabolism & Toxicology
550603 - Medicine- External Radiation in Therapy- (1980-)