Clinical trial NCT05553782: Drug Screening Using Novel IMD in ACC and Salivary Cancers
Official title: Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Adenoid Cystic Carcinoma (ACC) and Salivary Cancers: a Window of Opportunity Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma of the Salivary Gland
Keywords: Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma of the Salivary Gland
Implantable Microdevice IMD
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Adenoid Cystic Carcinoma Research Foundation
First posted: 2022-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants must have histologically confirmed adenoid cystic carcinoma (ACC) of the salivary glands of the head and neck 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). If initial fine needle aspiration (FNA) biopsy shows findings suggestive of ACC or a basaloid neoplasm, the patient is considered eligible. Initial FNAs showing unspecified salivary neoplasms should be discussed with the treating surgeon and PI.
* 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

Primary outcomes:
measure: Grade 3 or Higher Treatment-Related Toxicity Rate
timeFrame: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.
Secondary outcomes:
measure: Pharmacodynamic (PD)
timeFrame: Screening Period 1 day
measure: Evaluate the likelihood of independent drug or combination response/failure in this pilot population to determine the appropriateness of nominating therapies for further clinical investigation
timeFrame: through study completion, an average of 1 year
measure: Tumor Response
timeFrame: through study completion, an average of 1 year
measure: Gene Expression Level
timeFrame: through study completion, an average of 1 year
measure: Changes in Tumor Metabolism
timeFrame: through study completion, an average of 1 year
measure: Biomarker levels
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Glenn J. Hanna, M.D
role: PRINCIPAL_INVESTIGATOR
References: