This pilot phase I trial studies the side effects and how well omalizumab works in preventing repeat allergic reactions to oxaliplatin-based therapy in patients with stage IV gastrointestinal cancer. Monoclonal antibodies, such as omalizumab, block antibodies that play a role in the body’s allergic response and may prevent allergic reactions to oxaliplatin-based therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02266355.
PRIMARY OBJECTIVES:
I. To evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients.
II. To evaluate the safety of omalizumab (Xolair) when administered in this setting.
OUTLINE:
Patients receive omalizumab subcutaneously (SC) every 2 weeks during chemotherapy treatment. The first injection will be given at least 7 days after the development of an allergic reaction and at least 7 days before the next oxaliplatin dose. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
Lead OrganizationYale University
Principal InvestigatorStacey M Stein
