Omalizumab in Reducing Refractory Type I Hypersensitivity Reactions in Patients with Cancer Receiving Chemotherapy

Inclusion Criteria

• Patients with type I hypersensitivity reactions to chemotherapy agents including, but not exclusive to, platins, taxanes, or monoclonal agents as evidenced by typical immunoglobulin (Ig)E-mediated symptoms (ie. flushing, hives, dyspnea, wheezing, nausea, itchy eyes, nasal congestion, hypotension, angioedema) or tryptase level elevated above baseline during an infusion reaction * For various reasons, some, but not all, patients enrolled in the desensitization program may not have positive skin test data to confirm an IgE-mediated reaction; these reasons include 1) cutaneous toxicity of the drug precluding testing, 2) limited sensitivity of skin testing for the drug being tested, 3) lack of adequate testing reagent and controls
• Patients with breakthrough reactions requiring multiple desensitization interventions including failed 16-step protocols or intervention with additional antihistamine (requiring > 50 mg of short-acting 1st-generation antihistamine – i.e. diphenhydramine or hydroxyzine -or > 10 mg of long-acting 2nd generation antihistamine – i.e. cetirizine or loratadine)
• All cancer patients receiving chemotherapy agents
• Clinical indication for additional doses of the chemotherapy as determined by the patient’s oncologist
• Patients stable enough to undergo chemotherapy as determined by the patient’s oncologist
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Medically unable to undergo desensitization
• Unable to provide informed consent
• Known sensitivity to omalizumab
• Participants may not be receiving any other study agents
• Chemotherapy treatment schedule < 12 weeks
• Pregnant women; women of child-bearing potential should be using two forms of birth control while on the study; should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately
• Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with known diagnosis of a primary mast cell disease (ie. mastocytosis)