Panitumumab IRDye800 Optical Imaging Study

Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Panitumumab IRDye 800; Device: da Vinci Firefly; Device: IMAGE1 + ICG Hopkins telescope and/or VITOM

Detailed Description

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham Cancer Center
  • California
    • Stanford, California, United States, 94305
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
• Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
• Planned standard of care surgery with curative intent for squamous cell carcinoma
• Age ≥ 19 years
• Have life expectancy of more than 12 weeks
• Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
• 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

• Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800
• 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 monoclonal antibody therapies
• Pregnant or breastfeeding
• Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
• Magnesium or potassium lower than the normal institutional values
• Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
• TSH > 13 micro International Units/mL

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Panitumumab IRDye 800; Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Drug: Panitumumab IRDye 800; Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery; Other Names: Optical Imaging prior to surgery; Device: da Vinci Firefly; Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology); Device: IMAGE1 + ICG Hopkins telescope and/or VITOM; IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events	Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio	Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue.	7 days
Optimal timing of the surgical procedure to maximize tumor to background ratio	Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts	7 days

Collaborators and Investigators

• Sponsor: Eben Rosenthal
• Investigators: Principal Investigator: Eben L Rosenthal, MD, Stanford University

Publications and helpful links

General Publications

• Lu G, Nishio N, van den Berg NS, Martin BA, Fakurnejad S, van Keulen S, Colevas AD, Thurber GM, Rosenthal EL. Co-administered antibody improves penetration of antibody-dye conjugate into human cancers with implications for antibody-drug conjugates. Nat Commun. 2020 Nov 9;11(1):5667. doi: 10.1038/s41467-020-19498-y.
• Kapoor S, Lu G, van den Berg NS, Krishnan G, Pei J, Zhou Q, Martin BA, Baik FM, Rosenthal EL, Nishio N. Effect of Formalin Fixation for Near-Infrared Fluorescence Imaging with an Antibody-Dye Conjugate in Head and Neck Cancer Patients. Mol Imaging Biol. 2021 Apr;23(2):270-276. doi: 10.1007/s11307-020-01553-1. Epub 2020 Oct 19.
• Fakurnejad S, van Keulen S, Nishio N, Engelen M, van den Berg NS, Lu G, Birkeland A, Baik F, Colevas AD, Rosenthal EL, Martin BA. Fluorescence molecular imaging for identification of high-grade dysplasia in patients with head and neck cancer. Oral Oncol. 2019 Oct;97:50-55. doi: 10.1016/j.oraloncology.2019.08.008. Epub 2019 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): November 23, 2019
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: March 26, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Optical Imaging; Panitumumab
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: IRB-35064; ENT0050 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes