Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer

Launched by VANDERBILT-INGRAM CANCER CENTER · Jun 4, 2023

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ClinConnect Summary

This clinical trial is investigating a new method to help doctors identify the first lymph nodes that cancer may have spread to in patients with head and neck cancer. The study uses a special radioactive substance combined with a medication called panitumumab, which targets certain cancer cells. By using this combination along with advanced imaging techniques, researchers hope to improve the accuracy of finding these important lymph nodes during surgery, which can be crucial for understanding the extent of the disease and planning treatment.

To participate in this trial, individuals must be at least 19 years old and have a confirmed diagnosis of squamous cell carcinoma of the head and neck. They should be scheduled for surgery, and their cancer should be either node-negative (no signs of spread) or have suspicious nodes. Participants can expect to receive the 111In-panitumumab before their surgery, followed by imaging tests to see how well the treatment works in locating the cancerous lymph nodes. It's important to note that there are specific health criteria that need to be met to ensure safety, and some individuals with certain medical conditions or allergies may not be eligible.

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 19 years.
• • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck, clinically-staged as node-negative (cN0) or as clinically-suspicious node(s).
• • Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed.
• • Planned standard of care elective neck dissection for node-negative or node-positive disease.
• * Have acceptable hematologic status, kidney function, and liver function including the following clinical results:
• • Hemoglobin ≥ 9 gm/dL
• • White blood cell count \> 3000/mm\^3
• • Platelet count ≥ 100,000/mm\^3
• • Serum creatinine ≤ 1.5 times upper reference range
• Exclusion Criteria:
• • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
• • History of infusion reactions to monoclonal antibody therapies
• • History of allergies to iodine
• • Pregnant or breastfeeding.
• • Magnesium or potassium lower than the normal institutional values.
• • Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• • Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• • Severe renal disease or anuria.