Clinical trial NCT03485638: Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
Official title: Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumor Disease Including Colorectal Cancer
Head & Neck Squamous Cell Carcinoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for Cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

Brief summary: 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.

Detailed description: * Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.
* Observation and evaluation values

  ① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab

  ② Cetuximab Skin test using before cetuximab administration

  ③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction)

  ④ Check patient's underlying disease and allergy history
* Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used

Eligibility criteria: 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

Primary outcomes:
measure: Hypersensitivity reaction after cetuximab administration
timeFrame: Within 4 weeks after first administration
Secondary outcomes:
measure: Cetuximab specific IgE
timeFrame: within 4 weeks after first administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University
Study officials:
References:
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.
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.
citation: 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.
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. No abstract available.
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. doi: 10.4161/mabs.3.4.16293. Epub 2011 Jul 1.
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.
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. No abstract available.