©2022 Stanford Medicine
Panitumumab IRDye800 Optical Imaging Study
Not Recruiting
Trial ID: NCT02415881
Purpose
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.
Official Title
Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
Stanford Investigator(s)
Vasu Divi, MD
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)
Davud Sirjani, MD
Clinical Professor, Otolaryngology (Head and Neck Surgery)
John B. Sunwoo, MD
Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology
Eligibility
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
Intervention(s):
drug: Panitumumab IRDye 800
device: da Vinci Firefly
device: IMAGE1 + ICG Hopkins telescope and/or VITOM
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Grace Yi
650-242-2666