Actively Recruiting
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Led by University of Alabama at Birmingham · Updated on 2025-12-24
25
Participants Needed
1
Research Sites
508 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
CONDITIONS
Official Title
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
- Any T stage and any subsite within the head and neck scheduled for surgical resection
- Patients with recurrent disease or a new primary tumor are allowed
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Male or female patients age 18 years or older
- Life expectancy of more than 12 weeks
- Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
- Acceptable hematologic status, coagulation status, kidney function, and liver function including:
- Hemoglobin at least 9 gm/dL
- Absolute Neutrophil Count at least 1500
- White Blood Cell count greater than 3000/mm3
- Platelet count at least 100,000/mm3
- Serum creatinine no more than 1.5 times upper reference range
You will not qualify if you...
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- History of myocardial infarction, cerebrovascular accident, or uncontrolled congestive heart failure within 6 months prior to enrollment
- History of infusion reactions to any monoclonal antibody therapies
- Women who are pregnant or breast-feeding
- Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
- Magnesium or potassium levels below normal institutional values
- Receiving Class IA or Class III antiarrhythmic agents
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Thyroid-stimulating hormone level greater than 13 micro International Units/mL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
D
Destiny Talley, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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