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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
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