At a glance
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A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
In Brief
A Phase 2 clinical trial evaluating IRX-2, Cyclophosphamide, and 3 other interventions for Squamous Cell Carcinoma of the Oral Cavity. Completed, enrolled 105 participants across 22 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
Method of Administration: Cyclophosphamide is administered once by IV
Method of Administration: Indomethacin is administered orally for 21 days.
Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
Method of Administration: Omeprazole is administered orally for 21 days