TheranosticTrials.org

Clinical Trial · NCT03733210

Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer

Overview

This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying cancer that has spread to the lymph nodes in patients with squamous cell head and neck cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans make detailed, computerized pictures of areas inside the body where the drug is used. Giving panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help doctors find metastatic lymph nodes better than current methods \[positron emission tomography (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations\].

Sponsor

Stanford University

Phase

Phase 1

Contacts

Andrei Iagaru, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03733210

Eligibility

Inclusion

  • Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.
  • White blood cell count \> 3000/mm³.
  • Planned standard of care surgery with curative intent for squamous cell carcinoma.
  • Platelet count ≥ 100,000/mm³.
  • Serum creatinine ≤ 1.5 times upper reference range.
  • 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.
  • Hemoglobin ≥ 9 gm/dL.

Exclusion

  • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
  • Magnesium or potassium lower than the normal institutional values.
  • Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
  • Previous bilateral neck dissection.
  • Severe renal disease or anuria.
  • History of infusion reactions to monoclonal antibody therapies.
  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
  • Pregnant or breastfeeding.
  • Known hypersensitivity to deferoxamine or any of its components.