Panitumumab IRDye800 Optical Imaging Study

• Sponsor: Eben Rosenthal (Other)
• Overall Status: Completed
• CT.gov ID: NCT02415881
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Arm: 1
• Actual Duration (Months): 61.7
• Patients Per Site: 32
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: Panitumumab IRDye 800; Device: da Vinci Firefly; Device: IMAGE1 + ICG Hopkins telescope and/or VITOM	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Nov 23, 2019
• Actual Study Completion Date: Sep 21, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama	United States	35294
2	Stanford University, School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Eben Rosenthal

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
• ClinicalTrials.gov Identifier: NCT02415881
• Other Study ID Numbers: IRB-35064; ENT0050
• First Posted: Apr 14, 2015
• Last Update Posted: Sep 24, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Eben Rosenthal, Professor of Otolaryngology, Stanford University: Panitumumab; Optical Imaging
• Additional relevant MeSH terms: Head and Neck Neoplasms; Panitumumab

Study Results

No Results Posted as of Sep 24, 2021