Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer

Not Recruiting

Trial ID: NCT03405142

Purpose

This phase 2 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.

Official Title

A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer

Stanford Investigator(s)

Fred M Baik, MD
Fred M Baik, MD

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

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

* Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that is amenable to local sentinel node tracer injection, and scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy
* Cohort 2 (neck dissection only): Diagnosis 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

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
* Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
* History or evidence of interstitial pneumonitis or pulmonary fibrosis
* Hypersensitivity to dextran and/or modified forms

Intervention(s):

drug: Panitumumab-IRDye800

drug: Lymphoseek

Not Recruiting

Contact Information

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

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