Panitumumab IRDye800 Optical Imaging Study

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415881
• Other study ID #: IRB-35064
• Secondary ID: ENT0050
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: September 21, 2021

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 21, 2021
• Est. primary completion date: November 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• Panitumumab IRDye 800
Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

Device:
• da Vinci Firefly
Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Eben Rosenthal

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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