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New treatment option for HNSCC
Official title Window Trial of Fluorescently Labeled Panitumumab (Panitumumab-IRDye800) in Head and Neck Cancer
ClinicalTrials.gov ID: NCT06819228
What this study is testing
What is Panitumumab IRDye 800?
Panitumumab IRDye 800 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hnscc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is exploring the use of Panitumumab in Head and Neck Cancer. Panitumumab is an approved drug named Vectibix and is used as an anti-cancer agent in other cancers such as colorectal cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- ECOG performance status of 0 or 1
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- ECOG performance status of 0 or 1
- 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...
- 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...
- 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 14 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.
- 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...
- 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...
- 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...
- 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...
- 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, patient is symptomatic, and the values are unable to be corrected through standard repletion strategies.
- Evidence of QTcF prolongation on pretreatment ECG.
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.