Drug Screening Using Novel IMD in 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
Brigham and Women's Hospital
30 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- 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 Criteria4
- 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
Interventions
* Percutaneous CT image-guided placement of the microdevice(s). At least one, and up to 3, devices will be placed in each tumor. * Drugs will be released from the microdevice into local tumor tissues. The duration of drug release will be for a period of 3-5 days while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. * Each microdevice harbors up to 20 drugs and/or drug combinations relevant to the treatment of head and neck cancer. The drugs used will include some standard agents approved by the Food and Drug Administration (FDA) for treatment of different types of cancers, or drugs classes under investigational. * Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05553782