Phase II Study of Panitumumab-IRDye800 for Head and Neck Cancer

Sponsor: University of Alabama at Birmingham

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04511078

Provider View

This clinical trial is testing a new drug, panitumumab-IRDye800, to see if it can help doctors better identify cancerous tissue during surgery for head and neck cancer. The study also aims to understand the safety of this drug.

Patient Parameters

Program Overview

The study aims to find out if panitumumab-IRDye800 can help surgeons see cancer more clearly compared to normal tissue during surgery for head and neck cancer. This could potentially improve the accuracy of tumor removal and lead to better outcomes for patients. The study will also look at the safety of using this drug.

Description

Head and neck cancers can be hard to see during surgery, making it difficult for doctors to remove all the cancerous tissue. Currently, doctors use touch, sight, and quick lab tests during surgery to find the edges of the tumor, but this isn't always accurate. This can lead to cancer being left behind, which affects patient outcomes.

Panitumumab-IRDye800 is a new drug that helps highlight cancer cells, making them easier to see during surgery. This study is testing how well this drug works in helping surgeons identify cancerous tissue. The drug has shown promise in early tests, with few mild side effects and no serious reactions. In some cases, it has helped surgeons remove cancer that might have been missed otherwise.

The study is part of ongoing research to improve surgical outcomes for patients with head and neck cancer. By using this drug, doctors hope to improve the accuracy of tumor removal, which is crucial for patient survival and recovery.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of squamous cell carcinoma of the head and neck.
  • Scheduled for surgery to remove the cancer, including those with recurrent or new cancer.
  • Surgery planned with the goal of curing the cancer.
  • Male or female, aged 18 years or older.
  • Expected to live for more than 12 weeks.
  • Good overall health, able to carry out normal activities with some effort.
  • Acceptable blood, kidney, and liver function, including:
    • Hemoglobin level of at least 9 gm/dL.
    • Neutrophil count of at least 1500.
    • White blood cell count over 3000/mm3.
    • Platelet count of at least 100,000/mm3.
    • Serum creatinine no more than 1.5 times the normal range.

Exclusion Criteria

  • Taken an experimental drug within 30 days before starting the study drug.
  • Had a heart attack, stroke, or uncontrolled heart failure in the past 6 months.
  • History of allergic reactions to similar drugs.
  • Pregnant or breastfeeding women.
  • Abnormal heart rhythm on an ECG test.
  • Low magnesium or potassium levels.
  • Taking certain heart medications.
  • History of lung diseases like pneumonitis or fibrosis.
  • High thyroid-stimulating hormone (TSH) levels.

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