Head and Neck CancerDiagnostics and screeningDrugPhase 2
What this study is
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.
What's being tested
- Panitumumab-IRDye800
Intervention · DRUG
single dose infusion of panitumumab-IRDye800CW
Study details
- Official title
- Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Head and Neck Cancer
- Enrolling
- 25 people
- Starts
- 2021-04-02
- Est. completion
- 2030-12-31
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
- 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.
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Male or female patients age ≥ 18 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; Absolute Neutrophil Count ≥ 1500; White Blood Cell count > 3000/mm3; Platelet count ≥ 100,000/mm3; Serum creatinine ≤ 1.5 times upper reference range
You can't join if
- Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
- 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
- Norma Miller, RN · Contact(205) 975-6169ncmiller@uabmc.edu
- Jason Warram, PhD · Sub-investigator
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300005079
Principal investigator
Anthony Morlandt, DDS MD
University of Alabama at Birmingham
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.