Trial Search Results

Phase I Panitumumab IRDye800 Optical Imaging Study

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Intervention(s):

  • Drug: Panitumumab IRDye 800

Phase:

Phase 1

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

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

   - Age ≥ 19 years

   - Have life expectancy of more than 12 weeks

   - 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

   - Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or
   greater than 450 ms in females)

   - Magnesium or potassium lower than the normal institutional values

   - Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide,
   amiodarone, sotalol) antiarrhythmic agents.

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

   - TSH > 13 micro International Units/mL

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All