Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck; Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Panitumumab-IRDye800; 89-Zirconium (Zr-89) Panitumumab; Pinpoint IR IR9000 fluorescence imaging system (FIS); SPY-PHI IR9000 fluorescence imaging system (FIS); Explorer Air camera; PDE-NEO II camera; FIS-00 fluorescence imaging system (FIS); Da Vinci Firefly Imaging System; IGP-ELVIS-v4 Macroscopic Specimen Imager; Vevo 3100 LAZR-X; Pearl Triology Imaging System; Odyssey CLx Imaging System; Leica fluorescence microscope
Intervention description: 30 mg administered intravenously (IV); 0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV); Handheld fluorescence-imaging endoscope manufactured by Novadaq; Handheld fluorescence-imaging endoscope manufactured by Novadaq; Fluorescence camera manufactured by SurgVision; Medical infrared camera manufactured by Hamamatsu Photonics KK; Fluorescence-imaging system (FIS) manufactured by Hamamatsu Photonics KK; Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc; Macroscopic specimen imager manufactured by LI-COR Biosciences; Photoacoustic ultrasound imaging system manufactured by VisualSonics; Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences; Infrared fluorescent-imaging system manufactured by LI-COR Biosciences; Fluorescence microscope manufactured by Leica
Intervention MeSH terms: Panitumumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer

Summary:

      This study evaluates how well panitumumab-IRDye800 and 89Zr-panitumumab work in identifying
      cancer that has spread to the lymph nodes in patients with squamous cell head and neck
      cancer. Panitumumab-IRDye800 is a drug that contains a dye molecule that fluoresces during
      surgery to indicate cancerous tissue. 89Zr-panitumumab is a drug that contains a small amount
      of radiation, which makes it visible in positron emission tomography (PET) scans. PET scans
      make detailed, computerized pictures of areas inside the body where the drug is used. Giving
      panitumumab-IRDye800 and 89Zr-panitumumab to patients with head and neck cancer may help
      doctors find metastatic lymph nodes better than current methods [positron emission tomography
      (PET); computed tomography (CT); magnetic imaging resonance (MRI), or combinations].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.

          -  Subjects diagnosed with any T stage, any subsite within the head and neck that are
             scheduled to undergo surgical resection. Subjects with recurrent disease or a new
             primary will be allowed.

          -  Planned standard of care surgery with curative intent for squamous cell carcinoma.

          -  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:

          -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
             heart failure (CHF); significant liver disease; or unstable angina within 6 months
             prior to enrollment.

          -  Previous bilateral neck dissection.

          -  History of infusion reactions to monoclonal antibody therapies.

          -  Pregnant or breastfeeding.

          -  Magnesium or potassium lower than the normal institutional values.

          -  Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide,
             amiodarone, sotalol) antiarrhythmic agents.

          -  Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.

          -  Severe renal disease or anuria.

          -  Known hypersensitivity to deferoxamine or any of its components.