Implantable microdevice drug screening for salivary and head and neck cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.