NCT01987375

Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Cetuximab-IRDye800 as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Eben Rosenthal · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is an open label, single institution, Phase 1 dose-escalation study to determine the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery that attaches to cancer cells and appears to make them visible to the doctor when he uses a special camera during the operation. The investigators are evaluating whether or not the use of the study drug along with the special camera will better identify the cancer while patients are in the operating room.

Detailed description

This study will be a conventional 3+3 phase I study evaluating three escalating dose levels of intravenous infusion of cetuximab-IRDye800 for patients who tolerate a 100 mg test/loading dose of unlabeled cetuximab as part of the screening process. Two cohorts will be added that do not include a 100 mg unlabeled test/loading dose of cetuximab, but will include a 10 mg test dose prior to enrollment. One cohort of 6 patients will be added that includes a 100 mg unlabeled test/loading dose of cetuximab and a fixed 50 mg dose of cetuximab-IRDye800.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab-IRDye800	a single dose of the study drug following a single loading dose of unlabeled cetuximab

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-04-19
• Completion: 2017-04-19
• First posted: 2013-11-19
• Last updated: 2019-06-24

Locations

1 site across 1 country: United States