Clinical Trial · NCT03405142

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

Overview

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.

Sponsor

Stanford University

Phase

Phase 2

Contacts

Fred M Baik (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03405142

Drug / Compound

tilmanocept

Isotope(s):
Target(s):
  • Mannose Receptor (CD206/MRC1)
Ligand Class: Small Molecules
Chelator: DTPA

Eligibility

Inclusion

  • Platelet count ≥ 100,000/mm³
  • 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
  • White blood cell count \> 3000/mm³
  • Patients with recurrent disease or a new primary will be allowed
  • Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
  • Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results:
  • Planned standard of care surgery with curative intent for squamous cell carcinoma
  • Serum creatinine ≤ 1.5 times upper reference range
  • 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
  • Hemoglobin ≥ 9 gm/dL
  • Karnofsky performance status of at least 70% or ECOG/Zubrod level 1

Exclusion

  • History or evidence of interstitial pneumonitis or pulmonary fibrosis
  • Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
  • Magnesium or potassium lower than the normal institutional values