What this study is
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.
What's being tested
- Panitumumab
Intervention · BIOLOGICAL
- Indium In 111 Panitumumab
Intervention · OTHER
- Single Photon Emission Computed Tomography
Intervention · PROCEDURE
- Computed Tomography
Intervention · PROCEDURE
- Surgical Procedure
Intervention · PROCEDURE
Undergo standard of care surgery
- Imaging agent
Intervention · OTHER
Receive local injection of optical dye
- Intraoperative Imaging
Intervention · PROCEDURE
Undergo Intraoperative Imaging
- Near Infrared Imaging
Intervention · PROCEDURE
Undergo Near Infrared Imaging
- Electrocardiography
Intervention · PROCEDURE
Undergo Electrocardiography
- Biospecimen Collection
Intervention · PROCEDURE
Undergo blood sample collection
Both Panitumumab and Indium In 111 Panitumumab
Given by IV
Both Single Photon Emission Computed Tomography and Computed Tomography
Undergo SPECT/CT
Study details
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Conditions
- Head and Neck Squamous Cell Carcinoma · Recurrent Head and Neck Squamous Cell Carcinoma
- Enrolling
- 30 people
- Starts
- 2023-08-22
- Est. completion
- 2029-11-30
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
- Vanderbilt-Ingram Service Services for Timely Access · Contact800-811-8480cip@vumc.org
- Eben Rosenthal, MD · Principal investigator
Recruiting
Study team
Sponsor
Vanderbilt-Ingram Cancer Center
Study ID VICC-EDHAN23201P
Principal investigator
Eben Rosenthal, MD
Vanderbilt University/Ingram Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.