Education and Training
Panitumumab IRDye800 Optical Imaging Study
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Panitumumab IRDye 800
- device: da Vinci Firefly
- device: IMAGE1 + ICG Hopkins telescope and/or VITOM
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
Ages Eligible for Study
19 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Grace Yi
650-242-2666
Not Recruiting