Panitumumab IRDye800 Optical Imaging Study

Eben Rosenthal

Status and phase

Completed

Phase 1

Conditions

Head and Neck Cancer

Treatments

Drug: Panitumumab IRDye 800

Device: da Vinci Firefly

Device: IMAGE1 + ICG Hopkins telescope and/or VITOM

Study type

Interventional

Funder types

Other

Identifiers

NCT02415881

IRB-35064

ENT0050 (Other Identifier)

Details and patient eligibility

About

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Full description

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

Enrollment

64 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
Planned standard of care surgery with curative intent for squamous cell carcinoma
Age ≥ 19 years
Have life expectancy of more than 12 weeks
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
Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
Magnesium or potassium lower than the normal institutional values
Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
TSH > 13 micro International Units/mL