Testing the Best Dose of Fluorescently-Labeled Panitumumab before Surgery in Patients with Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Written informed consent
• Male or female patients age > 18 years
• Patients of any T stage and any N stage undergoing curative surgical resection for HNSCC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic and end-organ function appropriate for surgery and pmab infusion as determined by routine preoperative evaluation and clinical assessment by a medical oncologist or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and pmab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include: * Chemistry panel – potassium, blood urea nitrogen (BUN) (or urea), and creatinine * Complete blood count (CBC) with differential – white blood cells (WBC), including absolute neutrophil count (ANC), hemoglobin, hematocrit, and platelet count * Magnesium and phosphorus
• For women of childbearing potential: Agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below: * A woman is considered to be of childbearing potential if she is post-menarche, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of the uterus and/or both ovaries and/or both fallopian tubes). * Post-menopausal is defined as either: ** Age > 55 years old ** Age < 55 years and *** At least 12 months since last menstrual period, *** At least 6 months since last menstrual period and follicle stimulating hormone (FSH) > 40 international units (IU) * Women of childbearing potential must have a negative pregnancy test result within 14 days of study drug administration * Women will be encouraged to remain abstinent or use effective contraceptive methods during the study protocol period and for 2 months after the final dose of pmab * Examples of highly effective methods of contraceptive include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings) * Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception For men: Agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, as defined below: * With a female partner of childbearing potential or pregnant female partner, men will be encouraged to remain abstinent or use a condom during the treatment period and for 2 months after the final dose of pmab to avoid exposing the embryo. Men must agree to refrain from donating sperm during this same period

Exclusion Criteria

• Patients not eligible for standard of care surgical resection
• Patients with a history of infusion reactions or allergic reactions to pmab
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * History of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Active tuberculosis. Patients do NOT have to be screened for tuberculosis for this trial
• Significant cardiovascular disease (such as New York Heart Association class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
• Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. These drugs are known to interact with pmab and therefore any patients taking these medications within 30 days of screening will be ineligible for the trial
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment
• Magnesium or phosphorus that is lower than normal institutional values and the patient is symptomatic. If magnesium and phosphorus values are lower than the normal institutional values, the patient must also be asymptomatic to continue, the investigator, or designee, may correct through standard repletion strategies if time allows
• Evidence of Fridericia’s formula-corrected QT interval (QTcF) prolongation on pretreatment electrocardiogram (ECG) (greater than 480 ms)
• Any other reason the principal investigator (PI) or physician may deem a patient would be unsuitable for the research study