Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers (NCT05553782) | Clinical Trial Compass
RecruitingEarly Phase 1
Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
United States30 participantsStarted 2023-11-01
Plain-language summary
This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/
The name of the study intervention involved in this study is:
\-- implantable microdevice
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).
* Age 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
* A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.
\- Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.
* Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR \<2, and aPTT \<1.5x upper limit of normal.
* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Participants who are receiving any other investigational agents.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
* Pregnant women are excluded…
What they're measuring
1
Grade 3 or Higher Treatment-Related Toxicity Rate
Timeframe: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.