RecruitingEarly Phase 1NCT06819228

Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer


Sponsor

Vanderbilt-Ingram Cancer Center

Enrollment

18 participants

Start Date

Apr 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer. It works by attaching to the cancer cell in a unique way that allows the drug to get into the cancer tissue. In addition to the Panitumumab, participants will also receive a Panitumumab-IRDye800 (Pan800) or a fluorescently labeled Panitumumab infusion. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. The goal of this study is to use a novel and possibly safer approach to identify an optimal dose for panitumumab to treat cancer patients by using a new light-based therapy. In this study, different drug levels will be analyzed using this approach to understand how much drug reaches the tumor at different administered doses, which may help us provide safer and/or more effective therapies in the future. The goal is to identify the correct amount or dose of a drug that is needed for effective cancer therapies. Often, clinical studies look at how much of the drug can be tolerated before patients become sick, rather than how much of the drug is required to be effective. IRDye800 is an investigational dye that, when tested in the lab, helps various characteristics of human tissue show up better when using a special camera during surgery. Panitumumab-IRDye800 is a combination of the drug and the dye that attaches to cancer cells and appears to make them visible to the doctor when he or she uses the special camera during surgery. This will help the surgeon with clinical margins during surgery and will may have a clearer way to differentiate between cancer and healthy tissue.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specially labeled antibody (panitumumab-IRDye800) that glows under a special camera, helping surgeons see and remove head and neck cancer more precisely during surgery. It is a short 'window' study done just before the planned operation. **You may be eligible if...** - You are 18 or older - You have confirmed squamous cell carcinoma of the head and neck - You are scheduled to have surgery to remove the cancer as standard treatment - You are in good overall health (ECOG 0-1) with adequate blood and organ function **You may NOT be eligible if...** - You have had a prior severe allergic reaction to panitumumab or similar drugs - Your cancer has already spread to distant organs - You are pregnant or breastfeeding - Laboratory values are not acceptable for elective surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPanitumumab IRDye 800

Study participation would last approximately 60 days from screening to follow-up visits. Participants dose of Panitumumab would be based on weight and Panitumumab IRDye800 is dosed the same for all participants.


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06819228


Related Trials