Early clinical trial concept for boron neutron capture therapy: A critical assessment of the EORTC trial 11001

Applied Radiation and Isotopes

Volumn 67, Issue 7-8 SUPPL., 2009, Pages

  Wittig, A ^a   Collette, L ^b   Moss, R ^c   Sauerwein, W A ^a  

^a UNIVERSITY HOSPITAL ESSEN   (Germany)

^b EORTC DATA CENTER   (Belgium)

^c TNO   (Netherlands)

Author keywords

Binary treatment modality; Boron neutron capture therapy (BNCT); BPA; BSH; Early clinical trials; Radiotherapy; Trial design

Indexed keywords

BINARY TREATMENT MODALITY; BORON NEUTRON CAPTURE THERAPY (BNCT); BPA; BSH; EARLY CLINICAL TRIALS; TRIAL DESIGN;

BORON; BORON COMPOUNDS; RADIOTHERAPY; STANDARDIZATION; STRATEGIC PLANNING; TUMORS;

NEUTRONS;

4 BORONOPHENYLALANINE B 10; BOROCAPTATE;

ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONCENTRATION RESPONSE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG TISSUE LEVEL; FEMALE; HEAD AND NECK CARCINOMA; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; INFORMED CONSENT; LIVER METASTASIS; MALE; NEUTRON CAPTURE THERAPY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; SQUAMOUS CELL CARCINOMA; THYROID CANCER; TISSUE SECTION; TREATMENT PLANNING;

ADENOCARCINOMA; BOROHYDRIDES; BORON COMPOUNDS; BORON NEUTRON CAPTURE THERAPY; CARCINOMA, SQUAMOUS CELL; COLORECTAL NEOPLASMS; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; LIVER NEOPLASMS; MALE; NEOPLASMS; PHENYLALANINE; PROSPECTIVE STUDIES; RADIATION-SENSITIZING AGENTS; SULFHYDRYL COMPOUNDS; THYROID NEOPLASMS; TISSUE DISTRIBUTION;

EID: 67649398843     PISSN: 09698043     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.apradiso.2009.03.012     Document Type: Article

References (16)

1. Aihara T., Hiratsuka J., Morita N., Uno M., Sakurai Y., Maruhashi A., Ono K., and Harada T. First clinical case of boron neutron capture therapy for head and neck malignancies using 18F-BPA PET. Head Neck 28 (2006) 850-855
2. Busse P.M., Harling O.K., Palmer M.R., Kiger W.S., Kaplan J., Kaplan I., Chuang C.F., Goorley J.T., Riley K.J., et al. A critical examination of the results from the Harvard-MIT NCT program phase I clinical trial of neutron capture therapy for intracranial disease. J. Neurooncol. 62 (2003) 111-121
3. Dagrosa M.A., Viaggi M., Rebagliati R.J., Castillo V.A., Batistoni D., Cabrini R.L., Castiglia S., Juvenal G.J., and Pisarev M.A. Biodistribution of p-boronophenylalanine (BPA) in dogs with spontaneous undifferentiated thyroid carcinoma (UTC). Appl. Radiat. Isot. 61 (2004) 911-915
4. Dagrosa M.A., Thomasz L., Longhino J., Perona M., Calzetta O., Blaumann H., Rebagliati R.J., Cabrini R., Kahl S., et al. Optimization of boron neutron capture therapy for the treatment of undifferentiated thyroid cancer. Int. J. Radiat. Oncol. Biol. Phys. 69 (2007) 1059-1066
5. European Commission. The Rules Governing Medicinal Products in the European Union 〈http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm〉.
6. Heber E., Trivillin V.A., Nigg D., Kreimann E.L., Itoiz M.E., Rebagliati R.J., Batistoni D., and Schwint A.E. Biodistribution of GB-10 Na(2)(10)B10H10 compound for boron neutron capture therapy (BNCT) in an experimental model of oral cancer in the hamster cheek pouch. Arch. Oral. Biol. 49 (2004) 313-324
7. Hideghéty K., Sauerwein W., Wittig A., Götz C., Paquis P., Grochulla F., Haselsberger K., Wolbers J., Moss R., et al. Tissue uptake of BSH in patients with glioblastoma in the EORTC 11961 phase I BNCT trial. J. Neurooncol. 62 (2003) 145-156
8. ICH. 〈http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/eudralex_en.htm〉.
9. Kankaanranta L., Seppala T., Koivunoro H., Saarilahti K., Atula T., Collan J., Salli E., Kortesniemi M., Uusi-Simola J., et al. Boron neutron capture therapy in the treatment of locally recurred head and neck cancer. Int. J. Radiat. Oncol. Biol. Phys. 69 (2007) 475-482
10. Nano R., Barni S., Chiari P., Pinelli T., Fossati F., Altieri S., Zonta C., Prati U., Roveda L., and Zonta A. Efficacy of boron neutron capture therapy on liver metastases of colon adenocarcinoma: optical and ultrastructural study in the rat. Oncol. Rep. 11 (2004) 149-153
11. Sauerwein W., and Zurlo A. The EORTC Boron Neutron Capture Therapy (BNCT) Group: achievements and future projects. Eur. J. Cancer 38 (2002) S31-S34
12. US Food and Drug Administration, Regulatory Guidance. 〈http://www.fda.gov/cder/index.html〉.
13. Wittig A., Malago M., Collette L., Huiskamp R., Bührmann S., Nievaart V., Kaiser G.M., Jockel K.H., Schmid K.W., et al. Uptake of two 10B-compounds in liver metastases of colorectal adenocarcinoma for extracorporeal irradiation with boron neutron capture therapy (EORTC Trial 11001). Int. J. Cancer. 122 (2008) 1164-1171
14. Wittig, A., Sheu, S., Kaiser, G., Lang, S., Jöckel, K., Moss, R., Stecher-Rasmussen, F., Rassow, J., Collette, L., Sauerwein, W., 2008b. New indications for BNCT? Results from the EORTC trial 11001. In: Zonta, A., Altieri, S., Roveda, L., Barth, R. (Eds.), 13th International Congress on Neutron Capture Therapy "A new option against cancer", ENEA, Italian National Agency for New Technologies, Energy and the Environment, Florence, pp. 39-42.
15. Wittig A., Michel J., Moss R.L., Stecher-Rasmussen F., Arlinghaus H.F., Bendel P., Mauri P.L., Altieri S., Hilger R., et al. Boron analysis and boron imaging in biological materials for boron neutron capture therapy (BNCT). Crit. Rev. Oncol. Hematol. 68 (2008) 66-90
16. Wittig A., Arlinghaus H.F., Kriegeskotte C., Moss R., Appelman K., Schmid K.W., and Sauerwein W.A.G. Laser-SNMS in tissue: a powerful tool for elemental and molecular imaging in the development of targeted drugs. Mol. Cancer Ther. 7 (2008) 1763-1771