A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer
IRX-2 is designed to activate your own body's immune system so that it can better fight the
invasion of head and neck cancer. In pre-clinical studies, IRX-2 has been shown to activate
a number of different cells of the immune system.
IRX-2 was previously tested in a study of 13 patients with advanced head and neck cancer who
had been previously treated and failed chemotherapy and/or radiation therapy. The trials
were specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not
appear to have major side effects. Also, the researchers believed that further study in less
advanced head and neck cancer patients could be useful in obtaining more data on the safety
of IRX-2 as well as data on possible effects on tumors and on patient survival.
IRX-2 Regimen in Patients With Newly Diagnosed Stage III or IVA Squamous Cell Carcinoma of the Oral Cavity
The purpose of this study is to determine whether a pre-operative regimen of the study drug,
IRX-2, a human cell-derived biologic with multiple active cytokine components, plus a single
dose of cyclophosphamide, followed by 21 days of indomethacin, zinc-containing
multivitamins, and omeprazole is active in treatment of oral cavity cancer. The regimen is
intended to stimulate an immune response against the cancer.
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