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

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04840472

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: 111I-n panitumumab Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 30, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 111-In 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.	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)

Arm

Intervention/Treatment

Experimental: 111-In 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.

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)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Fred Baik, MD, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04840472

Other Study ID Numbers:

IRB-58398
ENT0083

First Posted:

Apr 12, 2021

Last Update Posted:

Mar 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Panitumumab

Study Results

No Results Posted as of Mar 15, 2022