Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Inclusion Criteria:

• Participants must meet all of the following criteria on screening examination to beeligible to participate in the study:

• Patients with type I hypersensitivity reactions to chemotherapy agents including, butnot exclusive to, platins, taxanes, or monoclonal agents as evidenced by typicalIgE-mediated symptoms (ie. flushing, hives, dyspnea, wheezing, nausea, itchy eyes,nasal congestion, hypotension, angioedema)

• For various reasons, some, but not all, patients enrolled in the desensitizationprogram may have positive skin test data to confirm an IgE-mediated reaction.

--These reasons include

• 1. cutaneous toxicity of the drug precludes testing
• 2. limited sensitivity of skin testing depending on the drug being tested with
• 3. lack of adequate testing reagent and controls.

• Patients with breakthrough reactions requiring multiple desensitization interventionsincluding 16 step protocols and intervention with additional antihistamine (requiring >50mg IV diphenhydramine or po hydroxyzine; OR >10mg cetirizine or loratadine)

• All cancer patients receiving chemotherapy agents, ages 18 and over.

• A positive skin test to the allergy-inducing agent or elevated tryptase level in thesetting of infusion reaction.

• Clinical indication for additional doses of the chemotherapy as determined by thepatient's oncologist.

• Patients stable enough to undergo chemotherapy as determined by the patient'soncologist.

• Ability to understand and the willingness to sign a written informed consentdocument.- We expect the majority of study patients to be women with ovarian cancer asthis patient population frequently receives platin therapy with paclitaxel as firstline therapy. This patient population also is at highest risk of developinghypersensitivity reactions to platin-based agents since these patients often receivemultiple rounds of chemotherapy.

Exclusion Criteria:

• Participants who exhibit any of the following conditions at screening will not beeligible for admission into the study.

• 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 birthcontrol while on the study. Should a woman become pregnant or suspect she is pregnantwhile participating in the study, she should inform her treating physicianimmediately.

• Uncontrolled illness including, but not limited to ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, orpsychiatric illness/social situations that would limit compliance with studyrequirements.

• Patients with underlying primary mast cell disease (ie. mastocytosis)

• Pregnant women are excluded from this study because carboplatin, cisplatin, andoxaliplatin are chemotherapeutic agent with the potential for teratogenic orabortifacient effects. Because there is an unknown but potential risk of adverseevents in nursing infants secondary to treatment of the mother with platin-basedagents, breastfeeding should be discontinued. These potential risks may also apply toother agents used in this study.