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

Trial ID or NCT#

NCT04840472

Status

not recruiting iconNOT RECRUITING

Purpose

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

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

Eligibility Criteria

Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Fred M Baik, MD
Fred M Baik, MD
Head and neck surgeon, Surgical oncologist, Cutaneous oncology specialist
Assistant Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Contact us to find out if this trial is right for you.

Contact

Alexander A Valencia
650-498-5185