This pilot phase I trial studies the side effects and best dose of panitumumab-IRDye800 in detecting cancer in patients with head and neck cancer undergoing surgery. Panitumumab-IRDye800 is a drug that attaches to cancer cells and makes them visible to doctors through a special camera that can be used during surgery. Panitumumab works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. IRDye800 is a dye that helps human tissue show up better when using the special camera. Panitumumab carries the dye into the cancer tissue, which allows doctors to see where the cancer is using a camera. Panitumumab-IRDye800 may allow doctors to see tumors more accurately and remove them successfully during surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02415881.
PRIMARY OBJECTIVE:
I. To determine the safety profile of panitumumab conjugated to the optical dye, IRDye800CW (panitumumab-IRDye800).
SECONDARY OBJECTIVES:
I. To determine the efficacy of panitumumab-IRDye800 to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) at various doses.
II. To determine the optimal timing of the surgical procedure to maximize the tumor to background ratio.
OUTLINE: This is a dose-escalation study of panitumumab-IRDye800. Patients are assigned to 1 of 4 groups.
GROUP 1: Patients receive lowest-dose panitumumab-IRDye800 intravenously (IV) over 15 minutes on day 0. Patients then undergo surgical resection 1-3 days after panitumumab-IRDye800 administration.
GROUP 2 A/B: Patients receive panitumumab IV over 60 minutes on day 0. After 15 minutes of observation, patients receive next higher-dose panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection 2-6 days after panitumumab-IRDye800 administration.
GROUP 2 C/3: Patients receive highest-dose panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection 1-5 days after panitumumab-IRDye800 administration.
GROUP 2D: Patients receive half of the highest-dose panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection as in Group 2C.
In all 4 groups, patients also undergo imaging using the Novadaq SPY/LUNA optical imaging system, Novadaq IR9000 open field fluorescence imaging system, or the SurgVision Explorer Air intra-operative multi spectral fluorescence reflectance system after panitumumab-IRDye800 administration, at each clinic visit, and intraoperatively before resection and after the tumor has been removed.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorEben Lloyd Rosenthal
