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.
This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
64
Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery
Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)
IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Stanford University, School of Medicine
Stanford, California, United States
Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events
Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.
Time frame: 30 days
Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio
Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue.
Time frame: 7 days
Optimal timing of the surgical procedure to maximize tumor to background ratio
Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts
Time frame: 7 days
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