Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients not eligible for standard of care surgical resection
Patients with a history of infusion reactions or allergic reactions to panitumumab.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.
Trial design
Design model
Sequential
Treatments tested in this trial
Panitumumab IRDye 800
DrugStudy 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Cohort 1a - Cohort 1fExperimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Determine maximum tumor concentrating dose (MTC) of panitumumab in HNSCC.
Drug concentration in the tumor will be measured (drug ng/tissue mg) utilizing special imaging devices (such as the Tecan Spark, LI-COR Pearl Trilogy, LI-COR Elvis, and LI-COR Odyssey). These devices will only be used once the tissue is removed per Standard of Care during surgery and then comparing cancerous tissue to healthy tissue. The maximum tumor concentrating dose will be defined as the lower dose of drug after two consecutive doses demonstrate the same maximum concentration of intra-tumoral drug. The investigators will further evaluate if multiple doses are required to fully concentrate HNSCC in Cohort 2. The MTC dose with 1 vs 2 infusions preoperatively will be compared.
Time frame
Up to 21 days per patientSecondary outcomes
1
Determine the maximal pharmacodynamic dose (MPD) of pmab and its correlation to MTCD.
Panitumumab-IRDye800 fluorescence and tissue analyses will be used to investigate whether the dose that achieves maximal tumor drug concentration also results in maximal suppression of the EGFR signaling pathway. Following surgical resection, tumor specimens will undergo spatial transcriptomic, proteomic, and immunohistochemical analyses to evaluate EGFR pathway inhibition and tumor cell growth arrest at different dose levels. Investigators have extensive experience using panitumumab-IRDye800 in clinical studies, and these tissue-based assessments are not expected to add additional risk to participants beyond standard specimen collection. Results will be used to correlate tissue drug concentration with molecular suppression of EGFR signaling, helping to identify the optimal biologic dose that achieves target saturation and therapeutic effect without requiring higher drug exposures.
Time frame
Up to 30 days per patientSponsors and contacts
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Source ClinicalTrials.gov