Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection

NCT03485638 | Unknown DMC

• 1 other identifier: 4-2016-0811
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Tumor Disease Including Colorectal Cancer; Head & Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cetuximab specific IgE

  within 4 weeks after first administration

Study Arms (1)

Cetuximab administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for Cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University

Seoul, 03722, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 20464886 BACKGROUND

• 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.

  PMID: 20147576 BACKGROUND

• 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.

  PMID: 18337601 BACKGROUND

• 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.

  PMID: 22162592 BACKGROUND

• 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.

  PMID: 21654207 BACKGROUND

• 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.

  PMID: 25296628 BACKGROUND

• 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.

  PMID: 19022494 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Jungwon Park, MD

CONTACT

+82 10 7389 3033; PARKJW@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: November 4, 2016
• Primary Completion: November 3, 2020
• Study Completion: November 3, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)