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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorVanderbilt-Ingram Cancer Center

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Panitumumab

    Biological/Vaccine

    Given by IV

  • Indium In 111 Panitumumab

    Other intervention

    Given by IV

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

  • Computed Tomography

    Procedure/Surgery

    Undergo SPECT/CT

  • Surgical Procedure

    Procedure/Surgery

    Undergo standard of care surgery

  • Imaging agent

    Other intervention

    Receive local injection of optical dye

  • Intraoperative Imaging

    Procedure/Surgery

    Undergo Intraoperative Imaging

  • Near Infrared Imaging

    Procedure/Surgery

    Undergo Near Infrared Imaging

  • Electrocardiography

    Procedure/Surgery

    Undergo Electrocardiography

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Diagnostic (panitumumab, 111In-panitumumab, SPECT/CT, surgery)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 15 days after administration of study drug

Secondary outcomes

1

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.

Time frame
Up to five years
2

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.

Time frame
Up to five years

Other outcomes

Sponsors and contacts

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Vanderbilt-Ingram Cancer Center

Lead sponsor

American Cancer Society, Inc.

Collaborator