Phase I single-dose study of intracavitary-administered Nimotuzumab labeled with 188Re in adult recurrent high-grade glioma

Cancer Biology and Therapy

Volumn 7, Issue 3, 2008, Pages 333-339

  Casacó Parada, Angel ^a   López, Gerardo ^b   García, Iván ^b   Rodríguez, José Arsenio ^c   Fernández, Ramsés ^b   Figueredo, Javier ^c   Torres, Leonel ^d   Perera, Alejandro ^d   Batista, Juan ^d   Leyva, René ^e   Peña, Yamilé ^d   Amador, Zaida ^e   González, Addys ^a   Estupiñan, Barbara ^b   Coca, Marcos ^d   Hernández, Abel ^d   Puig, Miguel ^b   Iglesias, Marbelia ^c   Hernández, Astrid ^f   Ramos, Mayra ^a   Rodríquez, Leyanis ^g   Suarez, Niurelkis ^h   more..

^a CENTER OF MOLECULAR IMMUNOLOGY   (Cuba)

^b CENTRO INTERNACIONAL DE RESTAURACIÓN NEUROLÓGICA CIREN   (Cuba)

^c Medical Surgical Research Center   (Cuba)

^d NATL CENTER FOR SCIENTIFIC RESEARCH   (Cuba)

^e Centro de Isotopos Cuba   (Cuba)

^f Centro Coordinador Nacional de Ensayos Clínicos CENCEC   (Cuba)

^g INSTITUTO DE FARMACIA Y ALIMENTOS   (Cuba)

^h INSTITUTO SUPERIOR DE CIENCIAS MÉDICAS DE LA HABANA   (Cuba)

Author keywords

Anti EGF R monoclonal antibody; Brain tumor; Gliomas; h R3; Nimotuzumab; Radioimmunotherapy; Rhenium

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR; NIMOTUZUMAB; RHENIUM 188;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; APHASIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BRAIN EDEMA; CLINICAL ARTICLE; CLINICAL TRIAL; CONFUSION; DEATH; DOSIMETRY; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLIOBLASTOMA; GLIOMA; HEADACHE; HUMAN; MALE; MAXIMUM TOLERATED DOSE; MUSCLE WEAKNESS; NUCLEAR MAGNETIC RESONANCE IMAGING; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; RADIATION NECROSIS; RADIOIMMUNOTHERAPY; RADIOISOTOPE DISTRIBUTION; SEIZURE; SIDE EFFECT; SINGLE DRUG DOSE;

EID: 45349101800     PISSN: 15384047     EISSN: 15558576     Source Type: Journal    
DOI: 10.4161/cbt.7.3.5414     Document Type: Article

References (43)

1. Davis FG, Freels S, Grutsch J, Barlas S, Brem S. Survival rates in patients with primary malignant brain tumors stratified by patient age and tumor histological type: an analysis based on surveillance, epidemiology, and end results (SEER) data, 1973-1991. J Neurosurg 1998; 88:1-10.
2. De Angelis LM. Brain tumors. N Engl J Med 2001; 344:114-23.
3. Harbaugh KS, Black PM. Strategies in the surgical management of malignant gliomas. Semin Surg Oncol 1998; 14:26-33.
4. Devaux BC, OíFallon JR, Kelly PJ. Resection, biopsy, and survival in malignant glial neoplasms. A retrospective study of clinical parameters, therapy, and outcome. J Neurosurg 1993; 78:767-75.
5. Halatsch ME, Schmidt U, Behnke-Mursch J, et al. Epidermal growth factor receptor inhibition for the treatment of glioblastoma multiforme and other malignant brain tumours. Cancer Treat Rev 2006; 32:74-89.
6. Goetz C, Riva P, Poepperl G, Gildehaus FJ, Hischa A, Tatsch K, Reulen HJ. Locoregional radioimmunotherapy in selected patients with malignant glioma: experiences, side effects and survival times. J Neurooncol 2003; 62:321-8.
7. Popperl G, Gotz C, Gildehaus FJ, Yousry TA, Reulen HJ, Hahn K, Tatsch K. Initial experiences with adjuvant locoregional radioimmunotherapy using 131I-labeled monoclonal antibodies against tenascin (BC-4) for treatment of glioma (WHO III and IV). Nuklearmedizin 2002; 41:120-8.
8. Riva P, Franceschi G, Riva N, Casi M, Santimaria M, Adamo M. Role of nuclear medicine in the treatment of malignant gliomas: the locoregional radioimmunotherapy approach. Eur J Nucl Med 2000; 27:601-9.
9. Riva P, Franceschi G, Arista A, Frattarelli M, Riva N, Cremonini AM, Giuliani G, Casi M. Local application of radiolabeled monoclonal antibodies in the treatment of high grade malignant gliomas: a six-year clinical experience. Cancer 1997; 80:2733-42.
10. Zalutsky MR. Targeted radiotherapy of brain tumours. Br J Cancer. 2004; 90:1469-73.
11. Nishikawa R, Sugiyama T, Narita Y, Furnari F, Cavenee WK, Matsutani M. Immunohistochemical analysis of the mutant epidermal growth factor, deltaEGFR, in glioblastoma. Brain Tumor Pathol 2004; 21:53-6.
12. Arteaga CL. The epidermal growth factor receptor: from mutant oncogene in nonhuman cancers to therapeutic target in human neoplasia. Semin Oncol. 2002; 29:3-9.
13. Mateo C, Moreno E, Amour K, Lombardero J, Harris W, Perez R. Humanization of a mouse monoclonal antibody that blocks the epidermal growth factor receptor: recovery of antagonistic activity. Immunotechnology 1997; 3:71-81.
14. Crombet T, Torres O, Rodriguez V, Menendez A, Stevenson A, Ramos M, Torres F, Figueredo R, Veitia I, Iznaga N, Perez R, Lage A. Phase I clinical evaluation of a neutralizing monoclonal antibody against epidermal growth factor receptor in advanced brain tumor patients: preliminary study. Hybridoma 2001; 20:131-6.
15. Crombet T, Torres L, Neninger E, Catala M, Solano ME, Perera A, Torres O, Iznaga N, Torres F, Perez R, Lage A. Pharmacological evaluation of humanized anti-epidermal growth factor receptor, monoclonal antibody h-R3, in patients with advanced epithelial-derived cancer. J Immunother 2003; 26:139-48.
16. Crombet T, Osorio M, Cruz T, Roca C, del Castillo R, Mon R, Iznaga-Escobar N, Figueredo R, Koropatnick J, Renginfo E, Fernandez E, Alvarez D, Torres O, Ramos M, Leonard I, Perez R, Lage A. Use of the humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 in combination with radiotherapy in the treatment of locally advanced head and neck cancer patients. J Clin Oncol 2004; 22:1646-54.
17. Ramos TC, Figueredo J, Catala M, Gonzalez S, Selva JC, Cruz TM, Toledo C, Silva S, Pestano Y, Ramos M, Leonard I, Torres O, Marinello P, Perez R, Lage A. Treatment of high-grade glioma patients with the humanized anti Epidermal Growth Factor Receptor (EGFR) antibody h-R3: Report from a Phase I/II trial. Cancer Biol Ther 2006; 5:375-9.
18. Maceira M, Rengifo E, Cedeno M, Merino N, Casaco Parada A. Immunohistochemical recognition of the epidermal growth factor receptor by the h-R3 antibody in the skin of experimental animals. App Immunohistochem Mol Morphol 2004; 12:360-3.
19. Arteaga-Perez ME, Maceira M, Casaco A, Hernandez-Sosa O, Bada-Barro AM, Leon-Goni A, Orphee-Suarez R, Cuevas-Fiallo A, Moreno-Diaz D, Padro-Gutierrez P, Baro-Gonzalez F, Rodriguez-Rodriguez V, Charoo-Ruiz L, Vazquez-Castro F, Ballester-Labrada A, Cedeno M. Multiple dose toxicity study of the humanized anti-epidermal growth factor receptor monoclonal antibody h-R3 intravenously administered to Cercopithecus aethiops sabaeus monkeys. Hum Exp Toxicol 2004; 23:219-27.
20. 188Re administered intracerebrally in rats. Hum Exp Toxicol 2000; 19:684-92.
21. 188osmiun after the intracerebral administration in rats. Exp. Toxicol Pathol 2005; 56:313-9.
22. Arteaga ME, Ledon N, Casaco A, Pardo B, García M, Boleda M, Viña L, Orphee R, Hernandez O, Gonzalez C, Fuentes D, Rodriguez V, Charro L, Baro F, Macias A, Perez A, Morales Y, Subiros N, Gonzalez B, Ramos M, Rodriquez L, Ballester-Labrada A, Crombet T. Systemic and Skin Toxicity in Cercopithecus aethiops sabaeus monkeys treated during 26 weeks with a high intravenous dose of the anti-epidermal growth factor receptor monoclonal antibody nimotuzumab. Cancer Biol Ther 2007, 9:(in press).
23. 188Re-direct labelling of monoclonal antibodies for radioimmunotherapy of solid tumors: Biodistribution, normal organ dosimetry, and toxicology. Nucl Med Biol 1998; 25:441-7.
24. 188re-labeled radiopharmaceuticals. An overview of promising results from initial clinical trials. Cancer Biother Radiopharm 2003; 18:707-17.
25. 188Re-labelled radiopharmaceuticals for radionuclide therapy. Nucl Med Commun 2006; 27:223-9.
26. Popperl G, Gotz C, Rachinger W, Schnell O, Gildehaus FJ, Tonn JC, Tatsch K. Serial O-(2-[(18)F]fluoroethyl)-L: -tyrosine PET for monitoring the effects of intracavitary radioimmunotherapy in patients with malignant glioma. Eur J Nucl Med Mol Imaging 2006; 33:792-800.
27. 188Re labelled humanized monoclonal antibody anti-Epidemal Growth Factor receptor Nimotuzumab in the locoregional treatment of malignant gliomas. Nucl Med Commun 2008; 29:66-75.
28. Macdonald DR, Cascino TL, Schold SC Jr, Cairncross JG. Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 1990; 8:1277-80.
29. Siegel JA, Thomas SR, Stubbs JB, Stabin MG, Hays MT, Koral KF, Robertson JS, Howell RW, Wessels BW, Fisher DR, Weber DA, Brill AB. MIRD pamphlet no. 16: techniques for quantitative radiopharmaceutical biodistribution data acquisition and analysis for use in human radiation dose estimates. J Nucl Med 1999; 40:37-61.
30. Cremonesi M, Ferrari M, Chinol M, Stabin MG, Grana C, Prisco G, Robertson C, Tosi G, Paganelli G. Three-step radioimmunotherapy with 90Y-biotin: dosimetry and pharmacokinetics in cancer patients. Eur J Nucl Med 1999; 26:110-20.
31. Stabin MG. MIRDOSE-the personal computer software for internal dose assessment in nuclear medicine. J Nucl Med 1996; 37:538-46.
32. 188Re labelled h-R3 locoregional RIT. Procedings of IAEA International Conference on Quality Assurance and new techniques in radiation medicine 2006; 146:92-94.
33. 188Re en una geometría voxel. Revista de Física Médica 2006; 7:101-6.
34. Thrall JH, Freitas JE, Swanson D, Rogers WL, Clare JM, Brown ML, Pitt B. Clinical comparison of cardiac blood pool visualization with technetium-99m red blood cells labeled in vivo and with technetium-99m human serum albumin. J Nucl Med 1978; 19:796-803.
35. Akabani G, Cokgor I, Coleman RE, Gonzalez Trotter D, Wong TZ, Friedman HS, Friedman AH, Garcia-Turner A, Herndon JE, DeLong D, McLendon RE, Zhao XG, Pegram CN, Provenzale JM, Bigner DD, Zalutsky MR. Dosimetry and dose-response relationships in newly diagnosed patients treated with 131I-labelled anti-tenascin monoclonal antibody therapy. Int J Rad Oncol Biol Phys 2000; 46:947-58.
36. Dixon KL. The radiation biology of radioimmunotherapy. Nucl Med Commun 2003; 24:951-7.
37. Libermann TA, Nusbaum HR, Razon N, Kris R, Lax I, Soreq H, Whittle N, Waterfield MD, Ullrich A, Schlessinger J. Amplification and overexpression of EGF receptor gene in primary human glioblastomas. J Cell Sci Suppl 1985; 3:161-72.
38. Crombet-Ramos T, Rak J, Pérez R, Viloria-Petit A. Antiproliferative, antiangiogenic and proapoptotic activity of h-R3: A humanized anti-EGFR antibody. Int J Cancer 2002; 101:567-75.
39. Carlsson J, Ren ZP, Wester K, Sundberg AL, Heldin NE, Hesselager G, Persson M, Gedda L, Tolmachev V, Lundqvist H, Blomquist E, Nister M. Planning for intracavitary anti-EGFR radionuclide therapy of gliomas. Literature review and data on EGFR expresión. J Neuooncol 2006; 77:33-45.
40. Paganelli G, Grana C, Chinol M, Cremonesi M, De Cicco C, De Braud F, Robertson C, Zurrida S, Casadio C, Zoboli S, Siccardi AG, Veronesi U. Antibody-guided three-step therapy for high grade glioma with yttrium-90 biotin. Eur J Nucl Med 1999; 26:348-57
41. Wersall P, Ohlsson I, Biberfeld P, Collins VP, von Krusenstjerna S, Larsson S, Mellstedt H, Boethius J. Intratumoral infusion of the monoclonal antibody, mAb 425, against the epidermal-growth-factor receptor in patients with advanced malignant glioma. Cancer Immunol Immunother 1997; 44:157-64.
42. Masucci G, Ragnhammar P, Wersall P, Mellstedt H. Granulocyte-monocyte colony-stimulating-factor augments the inter-leukin-2 induced cytotoxic activity of human lymphocytes in the absence and presence of mouse or chimeric monoclonal antibodies (mAb17-1A). Cancer Immunol Immunother 1990; 31:231-5.
43. Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol 2005; 23:1803-10.