RECRUITINGPhase 1INTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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: - blood count (hemoglobin) at least 9 gm/dL - White blood cell count \> 3000/mm\^3 - Platelet count ≥ 100,000/mm\^3 - Serum creatinine ≤ 1.5 times upper reference range Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

Panitumumab

Given by IV

OTHER

Indium In 111 Panitumumab

Given by IV

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT/CT

PROCEDURE

Computed Tomography

Undergo SPECT/CT

PROCEDURE

Surgical Procedure

Undergo standard of care surgery

OTHER

Imaging agent

Receive local injection of optical dye

PROCEDURE

Intraoperative Imaging

Undergo Intraoperative Imaging

PROCEDURE

Near Infrared Imaging

Undergo Near Infrared Imaging

PROCEDURE

Electrocardiography

Undergo Electrocardiography

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States