Trial Search Results

Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head and Neck Cancer

This phase II 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Procedure: Computed Tomography
  • Procedure: Lymphoscintigraphy
  • Drug: Panitumumab-IRDye800
  • Other: Pharmacological Study
  • Procedure: Single Photon Emission Computed Tomography
  • Radiation: Technetium Tc 99m-labeled Tilmanocept

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck

   - Patients diagnosed with any T stage, any subsite within the head and neck that are
   scheduled to undergo surgical resection, including a (modified) neck dissection

   - Patients with recurrent disease or a new primary will be allowed

   - Planned standard of care surgery with curative intent for squamous cell carcinoma

   - Tumor is accessible for local injection of the sentinel node tracer (for example oral
   cavity disease)

   - Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group
   (ECOG)/Zubrod level 1

   - Hemoglobin >= 9 gm/dL

   - White blood cell count > 3000/mm^3

   - Platelet count >= 100,000/mm^3

   - 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

   - Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
   amiodarone, sotalol) antiarrhythmic agents

   - Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

   - Hypersensitivity to dextran and/or modified form thereof

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nick Oberhelman
650-724-3866
Not Recruiting