Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma.

The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: 111I-n panitumumab
  • Procedure: Single photon emission computed tomography/computed tomography (SPECT/CT) scans

Phase:

Phase 1

Eligibility


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 elective neck dissection for a cN0 or cN1 disease. Clinical
   N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or
   less in greatest dimension by clinical exam, cross sectional imaging or metabolic
   imaging.

   - 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:

   - 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 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.

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
Alexander A Valencia
650-498-5185
Recruiting