Panitumumab IRDye800 Optical Imaging Study

Conditions

Head and Neck Cancer

Keywords

Panitumumab, Optical Imaging

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.

Jasper Vonk, Jaron G. de Wit, Floris J. Voskuil, Yang Tang, Wouter TR Hooghiemstra et al. (13 authors)

Journal of Nuclear Medicine2021-09-1620 citations

10.2967/jnumed.121.262530

Co-administered antibody improves penetration of antibody–dye conjugate into human cancers with implications for antibody–drug conjugates

Guolan Lu, Naoki Nishio, Nynke S. van den Berg, Brock A. Martin, Shayan Fakurnejad et al. (9 authors)

Nature Communications2020-11-0999 citations

10.1038/s41467-020-19498-y

Effect of Formalin Fixation for Near-Infrared Fluorescence Imaging with an Antibody-Dye Conjugate in Head and Neck Cancer Patients.

Kapoor S, Lu G, van den Berg NS, Krishnan G, Pei J, Zhou Q, Martin BA, Baik FM, Rosenthal EL, Nishio N.

2020-10-196 citations

10.1007/s11307-020-01553-1

Fluorescence molecular imaging for identification of high-grade dysplasia in patients with head and neck cancer.

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.

2019-08-1214 citations

10.1016/j.oraloncology.2019.08.008

The Clinical Application of Fluorescence-Guided Surgery in Head and Neck Cancer

Stan van Keulen, Naoki Nishio, Shayan Fakurnejad, Andrew C. Birkeland, Brock A. Martin et al. (12 authors)

Journal of Nuclear Medicine2019-02-07108 citations

10.2967/jnumed.118.222810

Interventions

DRUGPanitumumab IRDye 800

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

DEVICEda Vinci Firefly

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

DEVICEIMAGE1 + 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.

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events	30 days	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.

Secondary

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

Countries

United States

Outcome results

None listed