Head/Neck,
Phase I
Phase I
Adults
Not Available
Not Available
Rosenthal, Eben
Local
Vanderbilt University
07-17-2023
Eligibility
Not Available
Not Available
Not Available
Inclusion Criteria:
Age 19 years.
Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
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 node-negative or node-positive disease.
Have acceptable hematologic status, kidney function, and liver function including the following clinical results: * Hemoglobin 9 gm/dL * White blood cell count > 3000/mm\^3 * Platelet count 100,000/mm\^3 * 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
History of allergies to iodine
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.
Age 19 years.
Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
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 node-negative or node-positive disease.
Have acceptable hematologic status, kidney function, and liver function including the following clinical results: * Hemoglobin 9 gm/dL * White blood cell count > 3000/mm\^3 * Platelet count 100,000/mm\^3 * 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
History of allergies to iodine
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.
