Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Trial ID or NCT#
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.
Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
- - 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
- - 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.
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Alexander A Valencia