Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Implantable Microdevice (IMD)

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Brigham and Women's Hospital

Lead sponsor

Dana-Farber Cancer Institute

Sponsor institution

Adenoid Cystic Carcinoma Research Foundation

Collaborator