Panitumumab IRDye800 Optical Imaging Study

NCT ID: NCT02415881

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2021-09-21

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.

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.

Conditions

Head and Neck Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Panitumumab IRDye 800

Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Group Type: EXPERIMENTAL

Panitumumab IRDye 800

Intervention Type: DRUG

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

da Vinci Firefly

Intervention Type: DEVICE

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

IMAGE1 + ICG Hopkins telescope and/or VITOM

Intervention Type: DEVICE

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

Interventions

Panitumumab IRDye 800

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

Intervention Type: DRUG

da Vinci Firefly

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Optical Imaging prior to surgery

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eben Rosenthal

OTHER

Sponsor Role: lead

Responsible Party

Eben Rosenthal

Professor of Otolaryngology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eben L Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Stanford University, School of Medicine

Stanford, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33168818 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33078373 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31421471 (View on PubMed)

Other Identifiers

ENT0050

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-35064

Identifier Type: -

Identifier Source: org_study_id