Phase 2
N=3
Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
Head and Neck Squamous Cell Carcinoma · Squamous Cell Carcinoma of the Head and Neck (SCCHN) · Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03405142 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800 — 10; 5; 3; NA Lymph nodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab-IRDye800 (Drug); Lymphoseek (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Eben Rosenthal
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800 |
10; 5; 3; NA; 2; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03405142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.