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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

Eligibility

Eligible Ages
Over 19 Years
Eligible Genders
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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

More Details

Status
Completed
Sponsor
Eben Rosenthal

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.