Phase I Panitumumab IRDye800 Optical Imaging Study

This study is currently recruiting participants.

See

Contacts and Locations

Verified July 2017 by Eben Rosenthal, Stanford University

Sponsor:

Information provided by (Responsible Party):

Eben Rosenthal, Stanford University

ClinicalTrials.gov Identifier:

NCT02415881

First received: March 26, 2015

Last updated: July 12, 2017

Last verified: July 2017

History of Changes

Purpose

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	Intervention	Phase
Head and Neck Cancer	Drug: Panitumumab IRDye 800	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking 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

Resource links provided by NLM:

MedlinePlus related topics: Diagnostic Imaging Head and Neck Cancer

Drug Information available for: Panitumumab

U.S. FDA Resources

Further study details as provided by Eben Rosenthal, Stanford University:

Primary Outcome Measures:

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:

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


Estimated Enrollment:	23
Study Start Date:	November 2015
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02415881

Locations


United States, California
Stanford Cancer Institute	Recruiting
Stanford, California, United States, 94305
Contact: Alifia Hasan 650-721-6509 alifia@stanford.edu
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

Investigators


Principal Investigator:	Eben L Rosenthal, MD	Stanford University

More Information


Responsible Party:	Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier:	NCT02415881 History of Changes
Other Study ID Numbers:	ENT0050
Study First Received:	March 26, 2015
Last Updated:	July 12, 2017

Keywords provided by Eben Rosenthal, Stanford University:


Panitumumab Optical Imaging

Additional relevant MeSH terms:


Head and Neck Neoplasms Neoplasms by Site Neoplasms	Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 14, 2017

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