Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Drug: 111I-n panitumumab
* Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 111-In panitumumab<br>The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab. | Drug: 111I-n panitumumab<br>* Imaging Agent<br>Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans<br>* Day 1 to 5 (Day of Surgery inclusive)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC. | Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye | Sensitivity of systemic 111In panitumumab of identifying sentinel lymph nodes versus sensitivity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared | 10 days after surgery | 
| Compare specificity of systemic 111In panitumumab versus conventional local optical dye | Specificity of systemic 111In panitumumab of identifying sentinel lymph nodes versus specificity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared | 10 days after surgery |