Panitumumab IRDye800 Optical Imaging Study

Not Recruiting

Trial ID: NCT02415881

Age - 19 Years-N/A Condition - Head and Neck Cancers (H&N), H and N - Oral Cancer, H and N - Salivary Gland Cancer, H and N - Throat Cancer (Oropharynx, Laryngeal, Hypopharyngeal), H and N - Nasopharynx and Paranasal Sinus Cancers Gender - All Accepting Healthy Volunteers - No

Purpose

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.

Official Title

Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures

Stanford Investigator(s)

Vasu Divi, MD
Vasu Divi, MD

Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS)

Davud Sirjani, MD
Davud Sirjani, MD

Clinical Professor, Otolaryngology (Head and Neck Surgery)

John B. Sunwoo, MD
John B. Sunwoo, MD

Edward C. and Amy H. Sewall Professor in the School of Medicine and Professor, by courtesy, of Dermatology

Michael J. Kaplan, MD

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

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Intervention(s):

drug: Panitumumab IRDye 800

device: da Vinci Firefly

device: IMAGE1 + ICG Hopkins telescope and/or VITOM

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Grace Yi
650-242-2666

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