Trial Title:
Evaluating 111In Panitumumab for Nodal Staging in Head and Neck Cancer
NCT ID:
NCT05901545
Condition:
Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Panitumumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Panitumumab
Description:
Given by IV
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Other
Intervention name:
Indium In 111 Panitumumab
Description:
Given by IV
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Single Photon Emission Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo SPECT/CT
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Surgical Procedure
Description:
Undergo standard of care surgery
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Other
Intervention name:
Imaging agent
Description:
Receive local injection of optical dye
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Intraoperative Imaging
Description:
Undergo Intraoperative Imaging
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Near Infrared Imaging
Description:
Undergo Near Infrared Imaging
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Electrocardiography
Description:
Undergo Electrocardiography
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)
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.
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:
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.
Criteria for 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
- 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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Service Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Eben Rosenthal, MD
Email:
Principal Investigator
Start date:
August 22, 2023
Completion date:
November 30, 2029
Lead sponsor:
Agency:
Vanderbilt-Ingram Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05901545
