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 not 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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Yi
6502422666
Not Recruiting