Phase I 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. Identifier: NCT02415881
Recruitment Status : Recruiting
First Posted : April 14, 2015
Last Update Posted : July 30, 2018
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 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
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
Study Start Date : November 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

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

Primary Outcome Measures :
  1. Number of subjects in a cohort experiencing an adverse event that is possibly, probably or definitely related and clinically significant. [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Highest tumor to background ratio identifiable when comparing cancer to normal surrounding tissue. [ Time Frame: 1 year ]
  2. Number of days to produce the optimal timing of the surgical procedure to maximize tumor to background ratio [ Time Frame: 1 year ]

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

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 identifier (NCT number): NCT02415881

Contact: Stefania Chirita 650-723-1423

United States, Alabama
University of Alabama at Birmingham Cancer Center Not yet recruiting
Birmingham, Alabama, United States, 35294
Contact: Jason M. Warram, PhD    205-996-5000   
United States, California
Stanford University, School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Stefania Chirita    650-723-1423   
Principal Investigator: Eben Rosenthal, MD         
Sub-Investigator: Vasu Divi, MD         
Sub-Investigator: Chris Holsinger, MD         
Sub-Investigator: Michael Kaplan, MD         
Sub-Investigator: Davud Sirjani, MD         
Sub-Investigator: John Sunwoo, MD         
Sponsors and Collaborators
Eben Rosenthal
Principal Investigator: Eben L Rosenthal, MD Stanford University

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University Identifier: NCT02415881     History of Changes
Other Study ID Numbers: ENT0050
First Posted: April 14, 2015    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: January 2018

Keywords provided by Eben Rosenthal, Stanford University:
Optical Imaging

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs