Panitumumab IRDye800 Optical Imaging Study

• Status: Completed
• Trial end date: 2021-09-21
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

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

Details

• Lead Sponsor: Eben Rosenthal
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria

• Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck

• Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.

• Planned standard of care surgery with curative intent for squamous cell carcinoma

• Age ≥ 19 years

• Have life expectancy of more than 12 weeks

• Karnofsky performance status of at least 70% or ECOG/Zubrod level 1

• 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

• Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800

• 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 monoclonal antibody therapies

• Pregnant or breastfeeding

• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)

• Magnesium or potassium lower than the normal institutional values

• Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.

• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

• TSH > 13 micro International Units/mL