RWF_IRX-2 2015A

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

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.

Inclusion Criteria:
• Pathologically confirmed (histology or cytology) Stage III or IVA squamous cell cancer of the oral cavity (excluding lip)
• Disease surgically resectable with curative intent
• Karnofsky performance status (KPS) >=70%

Exclusion Criteria:
• Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care of this oral cavity cancer.
• Any medical contraindications or previous therapy that would preclude treatment with either IRX 2 Regimen 1 or 2 or the surgery, reconstruction or adjuvant therapy required to treat the oral tumor appropriately
• Clinical status of either subject or tumor such that administration of 21 day neoadjuvant IRX-2 Regimen 1 or 2 before surgery would be medically inappropriate
• Tumor of the oropharynx
Phase II
Oral, Head and Neck
R Bryan Bell, M.D.
IRX Therapeutics, Inc.
George Morris
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Westside