Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06819228

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

Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-05-08

18

Participants Needed

1

Research Sites

202 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing to review and sign written informed consent.
  • Male or female patients age > 18 years.
  • Tissue confirmation of head and neck squamous cell carcinoma.
  • Patients for whom a potentially curative resection is planned as standard of care.
  • ECOG performance status of 0 or 1.
  • Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation including magnesium, phosphorus, and serum pregnancy test within 30 days prior to treatment.
  • For women of childbearing potential: agreement to remain abstinent or use effective contraceptive methods during treatment and for 5 months after the final dose, with a negative pregnancy test within 14 days prior to treatment.
  • Men must agree to remain abstinent or use a condom during treatment and for 5 months after the final dose and refrain from sperm donation during this period.
Not Eligible

You will not qualify if you...

  • Patients not eligible for standard of care surgical resection.
  • History of infusion reactions or allergic reactions to panitumumab.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonitis on screening chest CT (radiation pneumonitis in radiation field permitted).
  • Active tuberculosis.
  • Significant cardiovascular disease, including NYHA Class II or greater disease, recent myocardial infarction or cerebrovascular accident within 3 months, unstable arrhythmia, or unstable angina.
  • History of severe allergic or anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
  • Current use of Class IA or Class III antiarrhythmic agents (quinidine, procainamide, dofetilide, amiodarone, sotalol) within 30 days.
  • Pregnancy, breastfeeding, or intention to become pregnant during treatment or within 5 months after the final dose.
  • Magnesium or phosphorus levels below normal institutional values that are symptomatic and cannot be corrected.
  • Evidence of QT prolongation on pretreatment ECG.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

N

Nicole Jones, Clinical Research Coordinator

CONTACT

C

Carleigh Burns

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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