No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Diagnostic
Participants needed
25 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for patients with head and neck cancer who will have surgery. Participants will receive a treatment called panitumumab-IRDye800 to see if it can help identify cancer better than normal tissue.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with squamous cell carcinoma of the head and neck
I am at least 18 years old
I have a life expectancy of more than 12 weeks
I am scheduled for surgery for my cancer
My general health status is good enough for surgery
I can provide acceptable results on blood tests
I have recurrent disease or a new primary
You may not be able to join if
I received an investigational drug in the last 30 days
I have had a heart attack or stroke in the last 6 months
I have a history of reactions to monoclonal antibody therapies
I am pregnant or breast-feeding
I have abnormal heart test results
My magnesium or potassium levels are too low
I take certain antiarrhythmic medications
I have a history of certain lung conditions
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of 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.
3. Planned standard…
Inclusion Criteria:
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of 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.
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
4. Male or female patients age ≥ 18 years
5. Have life expectancy of more than 12 weeks
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
1. Hemoglobin ≥ 9 gm/dL
2. Absolute Neutrophil Count ≥ 1500
3. White Blood Cell count \> 3000/mm3
4. Platelet count ≥ 100,000/mm3
5. Serum creatinine ≤ 1.5 times upper reference range
Exclusion Criteria:
1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
3. History of infusion reactions to any monoclonal antibody therapies
4. Women who are pregnant or breast-feeding
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
6. Magnesium or potassium lower than the normal institutional values
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
9. TSH \> 13 micro International Units/mL
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