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

• Pathologically confirmed Stage II, III, or IVA SCC of oral cavity (excluding lip)
• Disease surgically resectable with curative intent
• Karnofsky PS > or = 70%
• No prior surgery, XRT, or chemo for this disease other than emergency procedure required for supportive care
• No oropharynx tumor
• Heme labs wnl
• PT/PTT <1.4 uln
• Creatinine clearance >50mL/min
• No T4b disease as follows:
  • No involvement of pterygopalatine fossa, maxillary sinus, or facial skin
  • No gross extension of tumor to skull base, no pterygoid plate erosion
  • No sphenoid bone or foramen ovale involvement
  • No direct extension to prevertebral fascia
  • No extension to superior nasopharynx or Eustachian tube
  • No direct extension into neck with deep neck musculature involvement
  • No suspected invasion or encasement of carotid arteries
  • No direct extension of neck disease to involve skin
  • No direct extension to mediastinal structures
  • No regional metastases to supraclavicular neck
• No need for daily immunosuppression (eg. steroids)
• No need for continued systemic anticoagulation
• No symptomatic cardiopulmonary disease
• No prior diagnosis of cancer that has required treatment in last 5 years
• No prior axillary dissection

Primary- change in event-free survival; Secondary- OS, Safety, change in tumor size by time of surgery, TIL levels