RecruitingEarly Phase 1

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

United States18 participantsStarted 2025-04-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age). * For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below: • A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and/or both ovaries and/or both fallopian tubes). Post-menarchal is defined as either: * age \>55 years old * age \<55 years or less and * at least 12 months since last menstrual period, * at least 6 months since last menstrual period and FSH \> 40 IU * Women of childbearing potential must ha…

What they're measuring

Determine maximum tumor concentrating dose (MTC) of panitumumab in HNSCC.

Timeframe: Up to 21 days per patient

Trial details

NCT IDNCT06819228

SponsorVanderbilt-Ingram Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

Nicole Jones, Clinical Research Coordinator

615-936-2807 nicole.l.jones@vumc.org