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

Phase 1

Suspended

• Conditions: Head and Neck Cancer
• Interventions: Drug: 111I-n panitumumab; Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans

• Registration Number: NCT04840472
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-30
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 28

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
111-In panitumumab	111I-n panitumumab	The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.
111-In panitumumab	Single photon emission computed tomography/computed tomography (SPECT/CT) scans	The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.

Primary Outcome Measures

Name	Time	Method
Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.	15 days	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.

Secondary Outcome Measures

Name	Time	Method
Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye	10 days after surgery	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
Compare specificity of systemic 111In panitumumab versus conventional local optical dye	10 days after surgery	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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States