Status:
COMPLETED
Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
Lead Sponsor:
Eben Rosenthal
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Squamous Cell Carcinoma
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief 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 he...
Detailed Description
Detecting progression of squamous cell carcinoma of the head and neck (SCCHN) is clinically challenging, with the transition from Stage 2 (no metastasis) to Stage 3 or 4 (minimally to significantly me...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT03405142
Start Date
August 1 2019
End Date
April 27 2021
Last Update
November 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University, School of Medicine
Palo Alto, California, United States, 94304