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Panitumumab IRDye800 Optical Imaging Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02415881
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 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 : August 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

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 Name: 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.




Primary Outcome Measures :
  1. Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 7 days ]
    Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415881


Contacts
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Contact: Grace Yi 650-723-0387 gracesyi@stanford.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Cancer Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jason M. Warram, PhD    205-996-5000    mojack@uab.edu   
United States, California
Stanford University, School of Medicine Suspended
Stanford, California, United States, 94305
Sponsors and Collaborators
Eben Rosenthal
Investigators
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Principal Investigator: Eben L Rosenthal, MD Stanford University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT02415881    
Other Study ID Numbers: IRB-35064
ENT0050 ( Other Identifier: OnCore )
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Eben Rosenthal, Stanford University:
Panitumumab
Optical Imaging
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents