Phase I Panitumumab IRDye800 Optical Imaging Study

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of
conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma
(HNSCC) that undergo surgery with curative intent. Safety data from this trial will be
studied to assist in the selection of dose levels of panitumumab-IRDye800 for future
research. It is hoped that this study will also help in finding better methods for
identifying cancer intraoperatively for a more complete surgical resection.

Inclusion Criteria

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

- Patients diagnosed with any T stage, any subsite within the head and neck that are
scheduled to undergo surgical resection. Patients with recurrent disease or a new
primary will be allowed.

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

- Age ≥ 19 years

- Have life expectancy of more than 12 weeks

- 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

- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or
greater than 450 ms in females)

- Magnesium or potassium lower than the normal institutional values

- Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents.

- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

- TSH > 13 micro International Units/mL