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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04840472
• Other study ID #: IRB-58398
• Secondary ID: ENT0083
• Status: Suspended
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

The secondary objective is to 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 28
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.

• 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 a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging.

• Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:

• Hemoglobin = 9 gm/dL

• White blood cell count > 3000/mm3

• Platelet count = 100,000/mm3

• Serum creatinine = 1.5 times upper reference range

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.

• 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

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• 111I-n panitumumab
Imaging Agent

Procedure:
• Single photon emission computed tomography/computed tomography (SPECT/CT) scans
Day 1 to 5 (Day of Surgery inclusive)

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.	Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type.	15 days
Secondary	Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye	Sensitivity of systemic 111In panitumumab of identifying sentinel lymph nodes versus sensitivity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared	10 days after surgery
Secondary	Compare specificity of systemic 111In panitumumab versus conventional local optical dye	Specificity of systemic 111In panitumumab of identifying sentinel lymph nodes versus specificity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared	10 days after surgery