Using a fluorescently labeled drug to improve surgery for head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of Panitumumab-IRDye800, a fluorescently labeled version of the anti-cancer drug panitumumab, in patients with head and neck squamous cell carcinoma (HNSCC). The primary goal is to determine the optimal biologic dose of panitumumab while utilizing the fluorescent properties of the dye to enhance surgical visibility of cancerous tissues. Participants will receive the drug prior to surgery, where its effectiveness as an imaging agent will be evaluated to potentially reduce surgical margins and improve outcomes. The study aims to establish a new methodology for dose selection that minimizes toxicity in patients undergoing treatment.

Why it matters

Who can join: the full rules

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 have a negative pregnancy test result within 14 days prior to initiation of study treatment.
  * Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.
  * Men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab/pan800 to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period.

Exclusion Criteria:

* 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.

  • History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial.
* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.
* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
* Magnesium or phosphorus lower than normal institutional values, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.
* Evidence of QTcF prolongation on pretreatment ECG.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Eben L Rosenthal, MD — Vanderbilt University/Ingram Cancer Center
• Study coordinator: Makenna Brown, Clinical Research Coordinator
• Email: makenna.l.brown@vumc.org
• Phone: 615-421-4370

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.