Head & Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody
to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment
for colorectal cancer and head and neck cancer. It is known that allergic reactions can
occur in more than 5% of the patients, although the side effects are relatively low
compared with other chemotherapeutic agents. It is known that cetuximab can induce
hypersensitivity even at the first administration, unlike other anticancer drugs. In
this study, we aimed to establish a model to predict patients with hypersensitivity
reaction before administration of cetuximab and to provide safe chemotherapy.
2. Recruitment method and consent procedure The study is designed for analysis patients
scheduled for administration of cetuximab for the first time. Patients matching the
selection and exclusion criteria with voluntary agreement to the study will be enrolled.
Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab
administration.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | November 3, 2020 |
| Est. primary completion date | November 3, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult men and women over 18 years of age - Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease. Exclusion Criteria: - Patients who did not consent to the study voluntarily after IRB approval - Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.) - Those who can not read and understand the agreement |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, Murphy BA, Satinover SM, Hosen J, Mauro D, Slebos RJ, Zhou Q, Gold D, Hatley T, Hicklin DJ, Platts-Mills TA. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008 Mar 13;358(11):1109-17. doi: 10.1056/NEJMoa074943. — View Citation
George TJ Jr, Laplant KD, Walden EO, Davis AB, Riggs CE, Close JL, George SN, Lynch JW. Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment. J Support Oncol. 2010 Mar-Apr;8(2):72-7. — View Citation
Hansen NL, Chandiramani DV, Morse MA, Wei D, Hedrick NE, Hansen RA. Incidence and predictors of cetuximab hypersensitivity reactions in a North Carolina academic medical center. J Oncol Pharm Pract. 2011 Jun;17(2):125-30. doi: 10.1177/1078155209360853. Epub 2010 Feb 10. — View Citation
Jerath MR, Kwan M, Kannarkat M, Mirakhur B, Carey L, Valgus J, Platts-Mills TA, Tarrant TK. A desensitization protocol for the mAb cetuximab. J Allergy Clin Immunol. 2009 Jan;123(1):260-2. doi: 10.1016/j.jaci.2008.09.046. Epub 2008 Nov 20. — View Citation
Maier S, Chung CH, Morse M, Platts-Mills T, Townes L, Mukhopadhyay P, Bhagavatheeswaran P, Racenberg J, Trifan OC. A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions. Cancer Med. 2015 Jan;4(1):36-42. doi: 10.1002/cam4.333. Epub 2014 Oct 9. — View Citation
Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, Comby E, Bouhier-Leporrier K, Reimund JM, Le Mauff B. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs. 2011 Jul-Aug;3(4):396-401. Epub 2011 Jul 1. — View Citation
Pointreau Y, Commins SP, Calais G, Watier H, Platts-Mills TA. Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis. J Clin Oncol. 2012 Jan 20;30(3):334; author reply 335. doi: 10.1200/JCO.2011.38.4701. Epub 2011 Dec 12. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Hypersensitivity reaction after cetuximab administration | Adverse drug reaction after Cetuximab administration includes severe systemic allergic reaction such as anaphylaxis, urticaria, skin rash, dyspnea, shock and mental change. | Within 4 weeks after first administration | |
| Secondary | Cetuximab specific IgE | Cetuximab specific IgE measured by ImmunoCAP assay, ELISA | within 4 weeks after first administration |