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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 60 → 70 participants Secondary endpoint revised · Site contact updatedv8 Show 2 more changesShow less
    • Secondary endpoint revised
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Phase changed: Early Phase 1 → Phase 1 Enrollment increased: 18 → 60 participants · Eligibility criteria revisedv7 Show 2 more changesShow less
    • Enrollment increased: 18 → 60 participants
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv6
  4. Eligibility criteria shortened, about 89 wordsv5 See this version in full on ClinicalTrials.gov ↗
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to Apr 17, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Apr 2025 to Apr 17, 2025
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 24 to 18v3
  2. Start date: Feb 2025 to Apr 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06819228
Lead Sponsor Vanderbilt-Ingram Cancer Center
Conditions HNSCC, HNSCC,Larynx, Pharynx and Oral Cavity, SCC - Squamous Cell Carcinoma
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov