Using panitumumab-IRDye800 to improve cancer visualization in head and neck surgery

Phase II Open-Label Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures

This study is testing a new dye called panitumumab-IRDye800 to see if it helps doctors see cancer better during surgery for head and neck cancer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Drugs / interventions: panitumumab, cetuximab
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT04511078 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of panitumumab-IRDye800 in distinguishing cancerous tissue from normal tissue during surgical procedures for head and neck squamous cell carcinoma. The approach involves administering the drug to patients scheduled for surgical resection, allowing for better intraoperative visualization of tumors. By improving the accuracy of tumor margin assessment, the study seeks to enhance surgical outcomes and reduce the incidence of incomplete tumor resections. The safety profile of panitumumab-IRDye800 will also be characterized throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with biopsy-confirmed squamous cell carcinoma of the head and neck who are scheduled for curative surgical resection.

Not a fit: Patients who have received investigational drugs within 30 days prior to the study or those with certain health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more precise surgical resections and improved outcomes for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promise in using optical imaging techniques for cancer visualization, suggesting potential success for this novel approach.

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 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

Where this trial is running

Birmingham, Alabama

• University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Anthony Morlandt, DDS MD — University of Alabama at Birmingham
• Study coordinator: Destiny Talley, RN

Conditions: Head and Neck Cancer, panitumumab, optical imaging