Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
This study tests a new imaging agent called 111In-panitumumab that helps doctors identify which lymph nodes contain cancer that has spread from head and neck tumors. The agent is designed to light up cancer cells, making them easier for surgeons to find and remove during surgery. This is a Phase 1 trial focused on evaluating how safe this new approach is.
Key Objective:This trial tests whether 111In-panitumumab can help surgeons more accurately locate and remove sentinel lymph nodes containing cancer spread in head and neck squamous cell carcinoma patients.
Who to Consider:Patients with head and neck squamous cell carcinoma who are planning to undergo surgery and want to help advance improved methods for identifying cancer spread to lymph nodes should consider this trial.
Trial Parameters
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Brief Summary
This phase I trial tests the safety and effectiveness of indium In 111 panitumumab (111In-panitumumab) for identifying the first lymph nodes to which cancer has spread from the primary tumor (sentinel lymph nodes) in patients with head and neck squamous cell carcinoma (HNSCC) undergoing surgery. The most important factor for survival for many cancer types is the presence of cancer that has spread to the lymph nodes (metastasis). Lymph node metastases in patients with head and neck cancer reduce the 5-year survival by half. Sometimes, the disease is too small to be found on clinical and imaging exams before surgery. 111In-panitumumab is in a class of medications called radioimmunoconjugates. It is composed of a radioactive substance (indium In 111) linked to a monoclonal antibody (panitumumab). Panitumumab binds to EGFR receptors, a receptor that is over-expressed on the surface of many tumor cells and plays a role in tumor cell growth. Once 111In-panitumumab binds to tumor cells, it is able to be seen using an imaging technique called single photon emission computed tomography/computed tomography (SPECT/CT). SPECT/CT can be used to make detailed pictures of the inside of the body and to visualize areas where the radioactive drug has been taken up by the cells. Using 111In-panitumumab with SPECT/CT imaging may improve identification of sentinel lymph nodes in patients with head and neck squamous cell cancer undergoing surgery.
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 monoclona