Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
Trial ID or NCT#
The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).
Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma
- - Age ≥ 19 years. - 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. Subjects with recurrent disease or a new primary will be allowed. - Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions. - Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results: - Hemoglobin ≥ 9gm/dL - White blood cell count > 3000/mm3 - Platelet count ≥ 100,000/mm3 - Serum creatinine ≤ 1.5 times upper reference range - PTT = 11.5 - 14.4 seconds - INR = 0.9 - 1.2
- - 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 other 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
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Roan C Raymundo, BS
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