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

Stanford University

Status and phase: Suspended; Phase 1

Conditions: Head and Neck Cancer

Treatments: Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans; Drug: 111I-n panitumumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04840472

IRB-58398

ENT0083 (Other Identifier)

NCI-2021-05694 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 1 patient group

111-In panitumumab

Experimental group

Description:

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.

Treatment:

Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans

Drug: 111I-n panitumumab