This phase I trial studies the side effects and best dose of cetuximab-IRDye 800CW in detecting cancer in patients with head and neck cancer undergoing surgery. Cetuximab-IRDye 800CW is a drug that attaches to cancer cells and makes them visible to doctors through a special camera that can be used during surgery. Cetuximab is a chemotherapy drug that targets cancer cells, and IRDye800CW is a dye that helps tissue in the body show up better when using the special camera. Cetuximab carries the dye into the cancer tissue, which allows doctors to see where the cancer is using a camera. Cetuximab-IRDye 800CW may be a more accurate way to image tumors than previous treatments, which may allow doctors to see tumors more accurately and remove them more successfully during surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT01987375.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To determine the safety profile of cetuximab conjugated to the optical dye, IRDye800CW (cetuximab-IRDye800).
SECONDARY OBJECTIVES:
I. To determine the efficacy of cetuximab-IRDye800 to identify cancer compared to surrounding normal tissue.
II. To determine if fluorescence requires a 100 mg loading dose.
OUTLINE: This is a dose-escalation study of cetuximab-IRDye 800CW.
Patients receive a pretreatment test dose of unlabeled cetuximab intravenously (IV) over 30 minutes. After 30 minutes of observation, patients receive cetuximab-IRDye 800CW IV over 1 hour. Patients then undergo surgical resection 3-10 days after cetuximab-IRDye 800CW administration. Patients also undergo imaging using the SPY/LUNA fluorescence imaging system after cetuximab-IRDye 800CW administration, at each clinic visit, and intraoperatively before resection and after the tumor has been removed.
After completion of study, patients are followed up at days 15 and 30.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorEben Lloyd Rosenthal
