Panitumumab IRDye800 Optical Imaging Study

NCT02415881 | Completed Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: IRB-35064ENT0050
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Panitumumab; Optical Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio

  7 days

• Optimal timing of the surgical procedure to maximize tumor to background ratio

  7 days

Study Arms (1)

Panitumumab IRDye 800

EXPERIMENTAL

Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Drug: Panitumumab IRDye 800; Device: da Vinci Firefly; Device: IMAGE1 + ICG Hopkins telescope and/or VITOM

Interventions

Panitumumab IRDye 800 DRUG

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

Also known as: Optical Imaging prior to surgery

Panitumumab IRDye 800

da Vinci Firefly DEVICE

Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)

Panitumumab IRDye 800

IMAGE1 + ICG Hopkins telescope and/or VITOM DEVICE

IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.

Panitumumab IRDye 800

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eben Rosenthal: lead

Study Sites (2)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35294, United States

Location

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 33168818 DERIVED

• 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.

  PMID: 33078373 DERIVED

• 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.

  PMID: 31421471 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Eben L Rosenthal, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology

Study Record Dates

• First Submitted: March 26, 2015
• First Posted: April 14, 2015
• Study Start: August 1, 2016
• Primary Completion: November 23, 2019
• Study Completion: September 21, 2021
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)