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

• Status: Suspended
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Dextrans; Diethylenetriamine; Edetic Acid; Panitumumab; Pentetic Acid; Technetium Tc 99m Pentetate

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

• *SNB only cohort: Patients diagnosed with a T1-T2 stage tumor, any subsite within the head and neck that is amenable to local sentinel node tracer injection and are scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy

• *Neck dissection only cohort: Patients diagnosed 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

• Only one criterion to be checked for each participant.

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

• Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

• Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

• Hypersensitivity to dextran and/or modified form thereof