Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also evaluate the safety of omalizumab (Xolair) when administered in this setting.
This is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (HSR) for patients with stage IV GI cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
9
Omalizumab 300 mg SQ every 2 weeks
Yale University
New Haven, Connecticut, United States
Incidence of Recurrent HSR
Recurrent Oxaliplatin HSR in subjects treated with omalizumab
Time frame: up to 12 months
Safety of Omalizumab
Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4
Time frame: up to 12 months
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