Panitumumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Eben L Rosenthal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Vanderbilt-Ingram Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eben L Rosenthal, MD

Principal Investigator

Vanderbilt University/Ingram Cancer Center

Eligibility Criteria

This trial is for adults over 18 with head and neck squamous cell carcinoma planning to undergo surgery. Participants must have normal organ function, agree to use contraception if of childbearing potential, and not be pregnant or breastfeeding. Exclusions include severe allergies to certain antibodies, specific heart conditions, electrolyte imbalances that can't be corrected, active tuberculosis, lung fibrosis except certain types from radiation therapy.

Inclusion Criteria

I am scheduled for surgery to remove my cancer.

Willing to review and sign written informed consent

I am over 18 years old.

Exclusion Criteria

History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

I am not taking specific heart rhythm medications that could interact with the trial drug.

Patients with a history of infusion reactions or allergic reactions to panitumumab

Treatment Details

Interventions

• Panitumumab IRDye 800 (Monoclonal Antibodies)

Trial Overview The study tests Panitumumab-IRDye800 in patients with head and neck cancer during surgery. It combines the approved drug Panitumumab (Vectibix) with a fluorescent dye IRDye800 to make cancer cells visible using a special camera. The aim is to find the optimal dose that's effective for treating cancer without causing sickness.

Participant Groups

Group I: Cohort 2a - Cohort 2c Experimental Treatment 1 Intervention

These cohorts will receive one dose of Pan800 and and two doses of Panitumumab at a range of doses (varying of specific cohort).

Group II: Cohort 1a - Cohort 1c Experimental Treatment 1 Intervention

These cohorts will receive one dose each of Pan800 (50 mg) and Panitumumab at a range of doses (varying of specific cohort).

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Dr. Rick Wright

Vanderbilt-Ingram Cancer Center

Chief Medical Officer since 2023

MD

Dr. Ben Ho Park

Vanderbilt-Ingram Cancer Center

Chief Executive Officer since 2020

MD, PhD