Implantable microdevice drug screening for salivary and head and neck cancers
Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
This will test whether a tiny implantable microdevice can safely and quickly deliver and screen multiple cancer drugs inside salivary gland and other head and neck tumors in patients scheduled for surgical removal.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05553782 on ClinicalTrials.gov |
What this trial studies
This is a window-of-opportunity pilot in which a needle-sized implantable microdevice (IMD) is placed into previously untreated head and neck tumors a few days before planned surgical resection. The IMD releases very small amounts of up to 20 drugs or drug combinations locally into the tumor, then is removed along with the tumor 3–5 days later at the time of surgery. Retrieved tumor tissue around the device will be analyzed for local drug response and safety signals to see which agents produce favorable effects. The study is being done at Brigham and Women's Hospital/Dana-Farber with funding support from the Adenoid Cystic Carcinoma Research Foundation and will enroll about 30 patients.
Who should consider this trial
Good fit: Adults (age ≥18) with a measurable, previously untreated primary salivary gland, adenoid cystic, or squamous cell head and neck tumor who are medically fit for percutaneous device placement and definitive surgical resection are eligible.
Not a fit: Patients with recurrent, metastatic, unresectable disease, poor performance status, or abnormal clotting/laboratory values that prevent safe device insertion are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the device could help identify which drugs work directly in an individual patient's tumor and guide more effective, personalized postoperative treatment choices.
How similar studies have performed: Similar intratumoral microdevice approaches have produced promising pharmacodynamic readouts in other tumor types, but this is the first pilot use of the IMD in salivary and head and neck cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement. * Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Glenn J. Hanna, M.D — Dana-Farber Cancer Institute
- Study coordinator: Glenn J. Hanna, M.D.
- Email: glenn_hanna@dfci.harvard.edu
- Phone: (617) 632-3090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.