Dana-Farber Cancer Institute
Glenn J. Hanna
This research study is studying the effect of different drugs as possible treatments for adenoid cystic carcinoma (ACC), a type of head and neck cancer. The name of the study intervention involved in this study is: -implantable microdevice
Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma of the Salivary Gland
Implantable Microdevice (IMD)
Early Phase 1
This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated salivary gland ACC patients undergoing definitive oncologic resection. -This research study is a Pilot Study, which is the first-time investigators are examining this study device in ACC. The treatment received (surgery and/or chemotherapy) will be the normal standard-of-care treatment for ACC. However, the placement and removal of the microdevice is being tested for the first time in this type of cancer. This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery. The microdevice can hold up to 20 drugs in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers. It is expected that about 30 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease. AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.}}
Study Type : | Interventional |
Estimated Enrollment : | 20 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Adenoid Cystic Carcinoma (ACC) and Salivary Cancers: a Window of Opportunity Study |
Actual Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | October 31, 2024 |
Estimated Study Completion Date : | January 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM Newly diagnosed, localized ACC salivary cancers undergoing surgical resection Interventional radiology guided IMD placement Planned oncologic resection with IMD retrieval 3-5 days after placement Standard of care adjuvant treatment Tumor specimen analysis for local drug response and molecular analysis |
Combination Product: Implantable Microdevice (IMD) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215