About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Panitumumab
Biological/VaccineGiven by IV
Indium In 111 Panitumumab
Other interventionGiven by IV
Single Photon Emission Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Computed Tomography
Procedure/SurgeryUndergo SPECT/CT
Surgical Procedure
Procedure/SurgeryUndergo standard of care surgery
Imaging agent
Other interventionReceive local injection of optical dye
Intraoperative Imaging
Procedure/SurgeryUndergo Intraoperative Imaging
Near Infrared Imaging
Procedure/SurgeryUndergo Near Infrared Imaging
Electrocardiography
Procedure/SurgeryUndergo Electrocardiography
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Treatment groups
Trial outcomes
Primary outcomes
Incidence of adverse events grade 2 or higher
Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type
Secondary outcomes
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes
Will compare the sensitivity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes
Will compare the specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes to the sensitivity of conventional local injection with an optical dye at the time of surgery. Means and standard deviations for continuous characteristics will be presented. Frequency statistics will be presented for categorical variables. Graphical tools may be used to assess distributional properties of continuous variables.
Sponsors and contacts
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Vanderbilt-Ingram Cancer Center
Lead sponsor
American Cancer Society, Inc.
Collaborator