IMD Drug Screening for Adenoid Cystic Carcinoma

Not currently recruiting at 1 trial location

Overseen By Glenn J. Hanna, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational agents, Anticoagulants

Disqualifiers: Pregnancy, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for adenoid cystic carcinoma, a rare head and neck cancer, using an implantable microdevice (IMD). Researchers place the IMD in the tumor to test how different drugs affect the cancer. This trial suits individuals newly diagnosed with adenoid cystic carcinoma of the salivary glands, who are scheduled for surgery and do not have advanced or metastatic cancer. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic anticoagulation (blood thinners), this should be discussed with the study's principal investigator and your surgeon.

What prior data suggests that this implantable microdevice is safe for treating adenoid cystic carcinoma?

Research has shown that the implantable microdevice (IMD) is under testing for safety and practicality. This tiny device is placed directly into tumors to release medicine precisely where needed. In this early trial phase, the primary goal is to determine the IMD's safety for humans. Limited information exists about side effects or negative reactions. However, the focus remains on ensuring the device operates safely and delivers medicine effectively without causing harm. This phase helps researchers assess how well people tolerate the device before progressing to larger studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Implantable Microdevice (IMD) is unique because it offers a new approach to treating adenoid cystic carcinoma (ACC). Unlike standard treatments, which typically involve surgery followed by radiation or chemotherapy, the IMD allows for localized drug delivery directly into the tumor. This method enables researchers to assess how the tumor responds to different drugs in real-time, potentially leading to more personalized and effective treatment plans. Researchers are excited about this innovation because it could revolutionize how we understand individual tumor behavior and tailor therapies accordingly, offering hope for more precise and effective cancer care.

What evidence suggests that the implantable microdevice is effective for adenoid cystic carcinoma?

Research has shown that the implantable microdevice (IMD) is a new tool for testing multiple drugs directly inside tumors, such as those in adenoid cystic carcinoma (ACC). This device can hold up to 20 different drugs in small amounts, allowing them to interact with cancer cells through tiny openings. By testing these drugs directly in the tumor, researchers can quickly identify which ones might effectively stop cancer growth. In this trial, participants will undergo IMD placement followed by surgical resection and standard adjuvant treatment. Previous studies have demonstrated that targeting specific processes in ACC, like PRMT5, can significantly slow tumor growth. This suggests that the IMD could help discover effective treatments by focusing on drugs targeting these processes. ^{2 4 6 7 8}

Who Is on the Research Team?

Glenn J. Hanna, M.D

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with adenoid cystic carcinoma of the salivary glands, who are fit for surgery and have a tumor at least 1 cm in size. They must not be pregnant, on other experimental drugs, or have serious illnesses that could risk biopsy/surgery safety.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

My initial biopsy suggests I might have ACC or a similar condition.

My doctor says I'm fit for surgery and other procedures.

Exclusion Criteria

I do not have any severe illnesses that would make surgery or biopsy unsafe.

Participants who are receiving any other investigational agents

I am not pregnant, as pregnancy excludes me from this study due to potential risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

IMD Placement

Interventional radiology guided placement of the implantable microdevice (IMD) into the tumor

3-5 days

1 visit (in-person)

Surgical Resection

Planned oncologic resection with IMD retrieval and tumor specimen analysis for local drug response

1 day

1 visit (in-person)

Adjuvant Treatment

Standard of care adjuvant treatment following surgical resection

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomarker and gene expression analysis

up to 1 year

Post-operative visits up to 14 days

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Microdevice (IMD)

Trial Overview The study tests an implantable microdevice (IMD) to screen different drugs' effects on head and neck cancer. It's designed to see which treatments might work best for patients with adenoid cystic carcinoma.

How Is the Trial Designed?

Group I: IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Adenoid Cystic Carcinoma Research Foundation

Collaborator

Trials

7

Recruited

160+

Adenoid Cystic Carcinoma Research Foundation

Collaborator

Trials

3

Recruited

80+

Published Research Related to This Trial

A pilot trial demonstrated that a small drug-eluting device placed in brain tumors during surgery is safe for use in patients with high-grade gliomas.

The device can provide early molecular indicators of how well a drug is working, which may help doctors make more personalized treatment decisions for their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NanoNail Gives Drug Response Readouts In Situ. [2023]

A new minimally invasive method for implanting and retrieving microdevices in tumors has been successfully demonstrated, allowing for personalized assessment of cancer drug responses in live models, with no complications reported during the process.

The method showed high success rates in retrieving drug delivery sites, with a correlation between drug delivery and cancer cell death, indicating its potential efficacy for optimizing cancer treatments without the need for surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An interventional image-guided microdevice implantation and retrieval method for in-vivo drug response assessment. Bhagavatula, SK., Upadhyaya, K., Miller, BJ., et al.[2020]

The study introduces a silicon-based implantable drug delivery system (IDDS) that utilizes a microchip to release drugs in a controlled manner, showcasing its potential for in vivo applications.

The IDDS has been successfully tested both in vitro and in vivo with the therapeutic peptide leuprolide, indicating its efficacy in delivering medication effectively within the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEMS fabricated chip for an implantable drug delivery device. Sbiaa, Z.[2020]

The study demonstrated that a novel implantable microdevice (IMD) can be safely implanted and retrieved in patients with non-small cell lung cancer (NSCLC) during surgery, with a 93% retrieval success rate and no severe adverse reactions reported.

The IMD allows for localized delivery of multiple chemotherapeutic agents, showing differential tumor responses to the drugs, which could help tailor personalized treatment regimens based on individual tumor characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Intrathoracic Implantation of Multidrug-Eluting Microdevices for In Situ Chemotherapeutic Sensitivity Testing as Proof of Concept in Nonsmall Cell Lung Cancer. Tsai, LL., Phillips, WW., Hung, YP., et al.[2023]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/14564?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Drug Screening Using Novel IMD in ACC and Salivary ... 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 ...

2. uchicagomedicine.org uchicagomedicine.org/forefront/cancer-articles/2025/march/ai-helps-find-promising-therapeutic-target

AI helps find promising therapeutic target for rare salivary ... The results demonstrated that PRMT5 inhibition significantly suppressed tumor growth across multiple preclinical models, downregulating key ACC ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700538/

Outcomes in Adenoid Cystic Carcinoma: A 14-Year Analysis Advanced-stage disease (Stage III/IV) was common (64.3%, n=9). Overall survival was 85.7% (n=12) over a mean follow-up of 4.3 years. Smoking was ...

4. peearz.com peearz.com/trialsindex?nctid=NCT05553782

Drug Screening Using Novel IMD in ACC and Salivary Cancers 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.

5. accrf.org accrf.org/treatments/clinical-trials/open-studies/

Open Studies The most promising studies will involve drugs that (1) target the known mechanisms of action that drive ACC progression, (2) demonstrate activity in preclinical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05553782

Drug Screening Using Novel IMD in ACC and Salivary ... This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/531855

Drug Screening Using Novel IMD in ACC and Salivary ... 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.

8. withpower.com withpower.com/trial/early-phase-1-adenoid-cystic-carcinoma-of-the-salivary-gland-10-2023-e2fbe

IMD Drug Screening for Adenoid Cystic Carcinoma This trial tests a tiny device that releases multiple drugs directly into tumors in patients with a specific type of head and neck cancer.