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

• Status: Active, not recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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].

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal; Stanford University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria:

• 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 surgery with curative intent for squamous cell carcinoma.

• 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:

• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.

• Previous bilateral neck dissection.

• 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.

• Known hypersensitivity to deferoxamine or any of its components.