Trial Search Results

Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&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 accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Panitumumab-IRDye800
  • Drug: Lymphoseek

Phase:

Phase 2

Eligibility


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

   - *SNB only cohort: Patients diagnosed with a T1-T2 stage tumor, any subsite within the
   head and neck that is amenable to local sentinel node tracer injection and are
   scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy

   - *Neck dissection only cohort: 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

   - 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

      - Only one criterion to be checked for each participant.

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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Yi
6502422666
Recruiting