Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying
 cancer that has spread to the lymph nodes in patients with squamous cell head and neck
 cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during
 surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount
 of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans
 make detailed, computerized pictures of areas inside the body where the drug is used. Giving
 panitumumab IRDye800 and 89Zr panitumumab to patients with head and neck cancer may help
 doctors find metastatic lymph nodes better than current methods [positron emission tomography
 (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].
Participants receive standard of care 18F-FDG-PET/CT and/or 18F-FDG-PET/MRI to assess their
 cancer for surgical excision. Participants than receive panitumumab-IRDye800 dye and
 89Zr-panitumumab, both by intravenous (IV) infusion, on Day 0. Participants will undergo
 89Zr-panitumumab PET/CT imaging on Day 1 to 2, and then undergo surgical resection of the
 tumor at 2 to 5 days after infusion. Participants with cancer-positive lymph nodes vs
 cancer-negative lymph nodes will be analyzed as separate cohorts. Research imaging will be
 performed intraoperatively using optical imaging devices and a high-energy gamma probe.
 Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive
 (89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. After surgery,
 patients are followed up at 15 and 30 days.

 PRIMARY OBJECTIVES:

 I. Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zr
 panitumumab) for the detection of tumor-involved regional lymph nodes.

 SECONDARY OBJECTIVES:

 I. Determine the number (proportion) of lymph nodes determined to be tumor positive by
 histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr
 panitumumab labeling.

 EXPLORATORY OBJECTIVES:

 I. Determine the sensitivity and specificity of panitumumab IRDye800 for the detection of
 tumor-involved regional lymph nodes.

 II. Determine the number (proportion) of lymph nodes determined to be tumor positive by
 histological and/or pathological evaluation that were NOT predicted tumor-positive by
 panitumumab-IRdye800 labeling.

 optical imaging devices listed in Appendix B intraoperative high-energy gamma probe.
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 surgery with curative intent for squamous cell carcinoma.

 -  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.

 -  Previous bilateral neck dissection.

 -  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.

 -  Known hypersensitivity to deferoxamine or any of its components.