Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
Condition: Head and Neck Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Head and Neck (SCCHN); Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Panitumumab-IRDye800; Lymphoseek
Intervention description: Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy). Panitumumab dose is < 1/12 of the therapeutic dose.; Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution
Intervention MeSH terms: Panitumumab; Diethylenetriamine; Dextrans; Edetic Acid; Pentetic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck
      cancer that has spread to the lymph nodes in patients with head and neck cancer.
      Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical
      removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy
      than the current methods.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck

          -  Patients with recurrent disease or a new primary will be allowed

          -  Planned standard of care surgery with curative intent for squamous cell carcinoma

               -  Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that
                  is amenable to local sentinel node tracer injection, and scheduled to undergo
                  surgical resection of the tumor, including a sentinel node biopsy

               -  Cohort 2 (neck dissection only): Diagnosis with any T-stage, any subsite within
                  the head and neck that are scheduled to undergo surgical resection, including a
                  (modified) neck dissection

          -  Age ≥ 19 years

          -  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

          -  White blood cell count > 3000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Serum creatinine ≤ 1.5 times upper reference range

        EXCLUSION CRITERIA:

          -  Received an investigational drug within 30 days prior to first dose of
             panitumumab-IRDye800

          -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
             heart failure (CHF); significant liver disease; or unstable angina within 6 months
             prior to enrollment

          -  History of infusion reactions monoclonal antibody therapies

          -  Pregnant or breastfeeding

          -  Magnesium or potassium lower than the normal institutional values

          -  Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone,
             sotalol) antiarrhythmic agents

          -  History or evidence of interstitial pneumonitis or pulmonary fibrosis

          -  Hypersensitivity to dextran and/or modified forms