Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular
 imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

 The secondary objective is to compare sensitivity and specificity of identifying sentinel
 lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus
 conventional local injection with an optical dye at the time of surgery.
Inclusion Criteria:

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

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

 -  Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical
 N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or
 less in greatest dimension by clinical exam, cross sectional imaging or metabolic
 imaging.

 -  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:

 -  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 to monoclonal antibody therapies.

 -  Pregnant or breastfeeding.

 -  Magnesium or potassium lower than the normal institutional values.

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

 -  Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.

 -  Severe renal disease or anuria.