Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer

Launched by VANDERBILT-INGRAM CANCER CENTER · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Window Trial, is investigating a new way to use a drug called Panitumumab, which is commonly used to treat certain types of cancer, including colorectal cancer. In this study, patients with head and neck cancer will receive a special version of Panitumumab that has a fluorescent dye added to it. This dye helps doctors see cancer cells more clearly during surgery using a special camera, which could improve the chances of successfully removing the cancer while protecting healthy tissue.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with head and neck squamous cell carcinoma, with a plan for surgery that aims to cure the cancer. Participants also need to be in good health for surgery and must agree to certain contraceptive measures if they are of childbearing potential. This study aims to find the right dose of the drug that is both safe and effective, and it provides an opportunity for patients to receive innovative treatment while contributing to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Willing to review and sign written informed consent.
• • Male or female patients age \> 18 years.
• • Tissue confirmation of head and neck squamous cell carcinoma.
• • Patients for whom a potentially curative resection is planned as standard of care.
• • Adequate hematologic and end-organ function appropriate for surgery as determined by routine preoperative evaluation. If liver function, renal function and hematologic laboratory test results are acceptable for elective surgery, the patient is considered eligible for the study. Laboratory results that will need to be obtained within 30 days prior to initiation of study treatment: Magnesium, Phosphorus, serum pregnancy test (for females of childbearing age).
• * For women of childbearing potential: Agreement 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-menarchal, 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-menarchal is defined as either:
• • age \>55 years old
• • age \<55 years or less and
• • at least 12 months since last menstrual period,
• • at least 6 months since last menstrual period and FSH \> 40 IU
• • Women of childbearing potential must have a negative pregnancy test result within 30 days prior to initiation of study treatment.
• • Women must remain abstinent or use effective contraceptive methods during the treatment period and for 5 months after the final dose of panitumumab.
• • 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: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
• • • With a female partner of childbearing potential or pregnant female partner, men must agree to remain abstinent or use a condom during the treatment period and for 5 months after the final dose of panitumumab/pan800 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 panitumumab.
• • 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. The following drugs are known to interact with panitumumab and therefore any patients taking these medications within 30 days will be ineligible for the trial.
• • Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of study treatment.
• • Magnesium or phosphorus lower than normal institutional values unable to be corrected through standard repletion strategies.
• • Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater that 450 ms in females).