Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer

INCLUSION CRITERIA:

   - Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck

   - Patients with recurrent disease or a new primary will be allowed

   - Planned standard of care surgery with curative intent for squamous cell carcinoma

      - Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that
      is amenable to local sentinel node tracer injection, and scheduled to undergo
      surgical resection of the tumor, including a sentinel node biopsy

      - Cohort 2 (neck dissection only): Diagnosis with any T-stage, any subsite within
      the head and neck that are scheduled to undergo surgical resection, including a
      (modified) neck dissection

   - Age ≥ 19 years

   - Karnofsky performance status of at least 70% or ECOG/Zubrod level 1

   - Have acceptable hematologic status, coagulation status, kidney function, and liver
   function including the following clinical results:

   - Hemoglobin ≥ 9 gm/dL

   - White blood cell count > 3000/mm³

   - Platelet count ≥ 100,000/mm³

   - Serum creatinine ≤ 1.5 times upper reference range

EXCLUSION CRITERIA:

   - Received an investigational drug within 30 days prior to first dose of
   panitumumab-IRDye800

   - Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
   heart failure (CHF); significant liver disease; or unstable angina within 6 months
   prior to enrollment

   - History of infusion reactions monoclonal antibody therapies

   - Pregnant or breastfeeding

   - Magnesium or potassium lower than the normal institutional values

   - Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone,
   sotalol) antiarrhythmic agents

   - History or evidence of interstitial pneumonitis or pulmonary fibrosis

   - Hypersensitivity to dextran and/or modified forms