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

Tracking Information

First Received Date ^ICMJE

March 26, 2015

Last Updated Date

July 12, 2017

Start Date ^ICMJE

November 2015

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02415881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase I Panitumumab IRDye800 Optical Imaging Study

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic

Condition ^ICMJE

Head and Neck Cancer

Intervention ^ICMJE

Drug: Panitumumab IRDye 800

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

Other Name: Optical Imaging prior to surgery

Study Arms

Experimental: Panitumumab IRDye 800

Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Intervention: Drug: Panitumumab IRDye 800

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2018

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

19 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02415881

Other Study ID Numbers ^ICMJE

ENT0050

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Eben Rosenthal, Stanford University

Study Sponsor ^ICMJE

Eben Rosenthal

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eben L Rosenthal, MD

Stanford University

PRS Account

Stanford University

Verification Date

July 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top