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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05901545
• Other study ID #: VICC-EDHAN23201P
• Secondary ID: NCI-2023-03821
• Status: Recruiting
• Phase: Phase 1
• Start date: August 22, 2023
• Est. completion date: November 30, 2029

Study information

• Verified date: April 2024
• Source: Vanderbilt-Ingram Cancer Center
• Contact: Vanderbilt-Ingram Services for Timely Access
• Phone: 800-811-8480
• Email: cip[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE:

I. Assess the safety of indium In 111 panitumumab (111In-panitumumab) as a molecular imaging agent in patients with HNSCC.

SECONDARY OBJECTIVE:

I. Compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to day of surgery versus conventional local injection with an optical dye at the time of surgery.

EXPLORATORY OBJECTIVES:

I. Determine if systemic injection of 111In-panitumumab can identify tumor-positive lymph nodes on preoperative SPECT/CT.

II. When preoperative imaging information (eg, fludeoxyglucose F 18 [18F-FDG] positron emission tomography [PET]/CT and/or magnetic resonance imaging [MRI]) data is available:

IIa. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative MRI in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).

IIb. Evaluate the sensitivity, specificity, and negative predictive value of 111In-panitumumab SPECT/CT findings to the sensitivity, specificity, and negative predictive value of preoperative 18F-FDG PET/CT in identifying metastatic lymph nodes (histopathological results will serve as the gold standard).

OUTLINE:

Patients receive loading dose of panitumumab intravenously (IV) over 15 minutes followed by 111In-panitumumab IV bolus on day 0. Patients then undergo SPECT/CT scan between day 1 and day of standard of care surgery (up to day 5). During standard of care surgery, patients receive local injection of optical dye per surgeon's preference and undergo intraoperative and near infrared (NIR) imaging. Patients additionally undergo blood sample collection during screening and electrocardiography (ECG) during screening, on day 0, and on day 15 if indicated.

Patients are followed for up to 15 days after last dose of study medication.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2029
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

• Estimated Glomerular Filtration Rate (eGFR) = 60 mL/min/1.73 m^2

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Panitumumab
Given by IV

Other:
• Indium In 111 Panitumumab
Given by IV

Procedure:
• Single Photon Emission Computed Tomography
Undergo SPECT/CT
• Computed Tomography
Undergo SPECT/CT
• Surgical Procedure
Undergo standard of care surgery

Other:
• Imaging agent
Receive local injection of optical dye

Procedure:
• Intraoperative Imaging
Undergo Intraoperative Imaging
• Near Infrared Imaging
Undergo Near Infrared Imaging
• Electrocardiography
Undergo Electrocardiography
• Biospecimen Collection
Undergo blood sample collection

Locations

Country	Name	City	State
United States	Vanderbilt University/Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 15 days after administration of study drug
Secondary	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.	Up to five years
Secondary	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.	Up to five years