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

Phase 1

Recruiting

• Conditions: Recurrent Head and Neck Squamous Cell Carcinoma; Head and Neck Squamous Cell Carcinoma
• Interventions: Biological: Panitumumab; Other: Indium In 111 Panitumumab; Procedure: Single Photon Emission Computed Tomography; Procedure: Computed Tomography; Procedure: Surgical Procedure; Other: Imaging agent; Procedure: Intraoperative Imaging; Procedure: Near Infrared Imaging; Procedure: Electrocardiography; Procedure: Biospecimen Collection

• Registration Number: NCT05901545
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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...

Detailed 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:
...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-04
• Study First Posted: 2023-06-13
• Study Start: 2023-08-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2028-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Panitumumab	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Indium In 111 Panitumumab	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Imaging agent	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Single Photon Emission Computed Tomography	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Computed Tomography	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Surgical Procedure	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Intraoperative Imaging	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Near Infrared Imaging	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Electrocardiography	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)	Biospecimen Collection	Patients receive loading dose of panitumumab 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 NIR imaging. Patients additionally undergo blood sample collection during screening and ECG during screening, on day 0, and on day 15 if indicated.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events grade 2 or higher	Up to 15 days after administration of study drug	Toxicity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Summarized by grade, severity and type

Secondary Outcome Measures

Name	Time	Method
Specificity of systemic injection of 111In-panitumumab for identifying sentinel lymph nodes	Up to five years	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 ...
Sensitivity of systemic injection of indium In 111 panitumumab (111In-panitumumab) for identifying sentinel lymph nodes	Up to five years	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 ...

Trial Locations

Locations (1)

Vanderbilt University/Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States