A phase I clinical study of VB4-845: Weekly intratumoral administration of an anti-EpCAM recombinant fusion protein in patients with squamous cell carcinoma of the head and neck

Drug Design, Development and Therapy

Volumn , Issue 2, 2008, Pages 105-114

  MacDonald, Glen C ^a   Rasamoelisolo, Michèle ^a   Entwistle, Joycelyn ^a   Cizeau, Jeannick ^a   Bosc, Denis ^a   Cuthbert, Wendy ^b   Kowalski, Mark ^b   Spearman, Maureen ^a   Glover, Nick ^b  

^a Viventia Biotech Inc   (Canada)

^b Viventia Biotech Inc   (Canada)

Author keywords

EpCAM; Head and neck cancer; Immunotoxin; Phase I; VB4 845

Indexed keywords

ANTINEOPLASTIC AGENT; NEUTRALIZING ANTIBODY; UNCLASSIFIED DRUG; VB4 845;

ADULT; ADVANCED CANCER; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALBUMIN BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ANTIBODY RESPONSE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; CANCER PAIN; CANCER RECURRENCE; CLINICAL ARTICLE; CLINICAL EVALUATION; CLINICAL STUDY; CLINICAL TRIAL; COHORT ANALYSIS; CREATININE BLOOD LEVEL; DEHYDRATION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ERYTHEMA; FATIGUE; FEASIBILITY STUDY; FEMALE; FEVER; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GASTROINTESTINAL DISEASE; HEAD AND NECK CARCINOMA; HEADACHE; HEMATURIA; HUMAN; IMMUNOGENICITY; INFLUENZA; INJECTION SITE EDEMA; INJECTION SITE PAIN; INJECTION SITE REACTION; INJECTION SITE ULCER; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MOUTH ABSCESS; MULTICENTER STUDY; NAUSEA AND VOMITING; PAIN; PERFORMANCE; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; RIGOR; SIDE EFFECT; SKIN METASTASIS; SQUAMOUS CELL CARCINOMA; SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK; TONGUE EDEMA; TREATMENT RESPONSE; TUMOR BLEEDING;

EID: 67651159855     PISSN: None     EISSN: 11778881     Source Type: Journal    
DOI: None     Document Type: Article

References (41)

1. Azemar M, Djahansouzi S, Jäger E, et al. 2003. Regression of cutaneous tumor lesions in patients intratumorally injected with a recombinant single-chain antibody-toxin targeted to Erb2/HER2. Breast Can Res Treat, 82:155-164 (Pubitemid 37521971)
2. Balzar M, Winter MJ, de Boer CJ, et al. 1999. The biology of the 17-1A antigen (Ep-CAM). J Mol Med, 77:699-712.
3. Baselga J, Trigo JM, Bourhis J, et al. 2005. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum- refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol, 23:5568-5577 (Pubitemid 46300151)
4. Blick SK, Scott LJ. 2007. Cetuximab, a review of its use in squamous cell carcinoma of the head and neck and metastatic colorectal cancer. Drugs, 67:2585-2607 (Pubitemid 350159168)
5. Bonner JA, Harari PM, Giralt J, et al. 2006. Radiotherapy plus cetuximab for squamous-cell carinoma of the head and neck. N Engl J Med, 354:567-578 (Pubitemid 43209104)
6. Bossi P, Locati L, Licitra L. 2007. Biological agents in head and neck cancer. Expert Rev Anticancer Ther, 7:1643-1650 (Pubitemid 350303018)
7. Brown J, Cizeau J, Bosc D, et al. 2005. A preclinical profile of VB4-845™, a recombinant immunotoxin for targeting head and neck cancer. 96th Annual Meeting of the American Association of Cancer Research.
8. Cole RD, McGuirt F. 1995. Prognostic significance of skin involvement from mucosal tumors of the head and neck. Arch Otolaryngol Head Neck Surg, 121:1246-1248
9. De Boer CJ, Van Krieken JHJM, Janssen-van Rhijn CM, et al. 1999. Expression of Ep-CAM in normal, regenerating, metaplastic, and neoplastic liver. J Pathology, 188:201-206
10. Dequanter D, Mboti FB, Lothaire P, et al. 2005. Skin metastases from a head and neck carcinoma: a prognostic factor? B-Ent, 1:113-115 (Pubitemid 43779979)
11. Di Paolo C, Willuda J, Kubetzko S, et al. 2003. A recombinant immunotoxin derived from a humanized epithelial cell adhesion molecule-specific single-chain antibody fragment has potent and selective antitumor activity. Clin Cancer Res, 9:2837-2848 (Pubitemid 36842130)
12. Fitzgerald D, Pastan I. 1989. Targeted toxin therapy for the treatment of cancer. J Natl Cancer Inst, 81:1455-1463 (Pubitemid 19252396)
13. Gebbia V, Giuliani G, Valori VM, et al. 2007. Cetuximab in squamous cell head and neck carcinomas. Ann Oncol, 18(supp6):vi5-vi7.
14. Haddad R, Allen A, Wirth L, et al. 2006. Integrating novel agents into the curative treatment of head and neck cancer. Expert Rev Anticancer Ther, 6:157-159 (Pubitemid 44192927)
15. Herbst RS, Arquette M, Shin DM, et al. 2005. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol, 23:5578-5587 (Pubitemid 46300152)
16. Jerjes W, Upile T, Betz CS, et al. 2007. The application of photodynamic therapy in the head and neck. Dent Update, 34:478-486
17. Laimer K, Fong D, Gastl G, et al. 2008. EpCAM expression in squamous cell carcinoma of the oral cavity: frequency and relationship to clinicopathologic features. Oral Oncol, 44:72-77 (Pubitemid 350251282)
18. Le Tourneau C, Faivre S, Siu LL. 2007. Molecular targeted therapy of head and neck cancer: review and clinical development challenges. Eur J Cancer, 43:2457-2466 (Pubitemid 350086931)
19. León X, Hitt R, Constenla M, et al. 2005. A retrospective analysis of the outcome of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck refractory to a platinum-based chemotherapy. Clin Oncol (R Coll Radiol), 17:418-424 (Pubitemid 41136136)
20. Litvinov SV, Velders MP, Bakker HA, et al. 1994. Ep-CAM: a human epithelial antigen is a homophilic cell-cell adhesion molecule. J Cell Biol, 125:437-446
21. Litvinov SV, Balzar M, Winter MJ, et al. 1997. Epithelial cell adhesion molecule (Ep-CAM) modulates cell-cell interactions mediated by classic cadherins. J Cell Biol, 139:1337-1348 (Pubitemid 27523219)
22. MacDonald GC, Glover N. 2005. Effective tumor targeting: strategies for the delivery of armed antibodies. Curr Opin Drug Discov Devel, 8:177-183 (Pubitemid 40348970)
23. Pastan I, Hassan R, Fitzgerald DJ, et al. 2006. Immunotoxin therapy of cancer. Nat Rev Cancer, 6:559-565
24. Pastan I, Hassan R, Fitzgerald DJ, et al. 2007. Immunotoxin treatment of cancer. Ann Rev Med, 58:221-237
25. Perentesis JP, Miller SP, Bodley JW. 1992. Protein toxin inhibitors of protein synthesis. Biofactors, 3:173-184
26. Pitman KT, Johnson JT. 1999. Skin metastases from head and neck squamous cell carcinoma: incidence and impact. Head Neck, 21:560-565 (Pubitemid 29415162)
27. Posner M. 2007. Evolving strategies for combined-modality therapy for locally advanced head and neck cancer. Oncologist, 12:967-974 (Pubitemid 47359139)
28. Posner MR, Wirth LJ. 2006. Cetuximab and radiotherapy for head and neck cancer. N Engl J Med, 354:634-636 (Pubitemid 43209112)
29. Rand RW, Kreitman RJ, Patronas N, et al. 2000. Intratumoral administration of recombinant circularly permuted interleukin-4-Pseudomonas exotoxin in patients with high grade glioma. Clin Can Res, 6:2157-2165
30. Robert F, Ezekiel MP, Spencer SA, et al. 2001. Phase 1 study of anti-epidermal growth factor receptor antibody cetuximab in combination with radiation therapy in patients with advanced head and neck cancer. J Clin Oncol, 19:3234-3243
31. Schmelzer F, Reid LM. 2008. EpCAM expression in normal, non-pathological tissues. Front Biosci, 13:3096-3100
32. Siegall CB, Liggitt D, Chace D, et al. 1997. Characterization of vascular leak syndrome induced by the toxin component of Pseudomonas exotoxin- based immunotoxins and its potential inhibition with nonsteroidal anti-inflammatory drugs. Clin Cancer Res, 3:339-345
33. Sittel C, Gossmann A, Jungehulsing M, et al. 2001. Superselective embolization as palliative treatment of recurrent hemorrhage in advanced carcinoma of the head and neck. Ann Otol Rhinol Laryngol, 110:1126-1128
34. Stoecklein NH, Siegmund A, Scheunemann P, et al. 2006. EpCAM expression in squamous cell carinoma of the esophagus: a potential therapeutic target and prognostic marker. BMC Cancer, 6:165-173
35. van Herpen CM, Huijbens R, Looman M, et al. 2003. Pharmacokinetics and immunological aspects of a phase Ib study with intratumoral administration of recombinant human interleukin-12 in patients with head and neck squamous cell carcinoma: a decrease of T-bet in peripheral blood mononuclear cells. Clin Can Res, 9:2950-2956
36. van Herpen CM, Looman M, Zonneveld M, et al. 2004. Intratumoral administration of recombinant interleukin 12 in head and neck squamous cell carcinoma patients elicits a T-helper 1 profile in the locoregional lymph nodes. Clin Can Res, 10:2626-2635
37. von Mehren M, Adams GP, Weiner LM. 2003. Monoclonal antibody therapy in cancer. Ann Rev Med, 54:343-369
38. Went PT, Lugli A, Meier S, et al. 2004. Frequent EpCam protein expression in human carcinomas. Hum Pathol, 35:122-128
39. Winter MJ, Nagtegaal ID, van Krieken JH, et al. 2003. The epithelial cell adhesion molecule (Ep-CAM) as a morphoregulatory molecule is a tool in surgical pathology. Am J Pathol, 163:2139-2148
40. Yanamoto S, Kawasaki G, Yoshitomi I, et al. 2007. Clinicopathologic significance of EpCAM expression in squamous cell carcinoma of the tongue and its possibility as a potential target for tongue cancer gene therapy. Oral Oncol, 43:869-877
41. Yoskovitch A, Hier MP, Okrainec A, et al. 2001. Skin metastases in squamous cell carcinoma of the head and neck. Otolaryngol Head Neck Surg, 124:248-252