Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer
Vanderbilt-Ingram Cancer Center
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.
Description
The primary objective of this study is to understand biologic dosing of panitumumab which would contribute to the field by establishing new methodology for dose selection with the aim of reducing toxicity in cancer patients. For the individual patient in this trial, panitumumab itself is unlikely to demonstrate anti-tumor efficacy. However, previous studies have shown some benefit when using panitumumab-IRDye800 (pan800) as an imaging agent intraoperatively. The investigators hope to improve patient outcomes by gathering clinical data to support pan800 as a tool for reducing positive surgical…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 resu…
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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee