IMD Drug Screening for Adenoid Cystic Carcinoma

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

20 Participants Needed

Trial Summary

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.

How is the Implantable Microdevice (IMD) treatment unique for adenoid cystic carcinoma?

The Implantable Microdevice (IMD) is unique because it allows for in-vivo (inside the body) testing of multiple cancer drugs directly within the tumor, helping to identify the most effective treatment without exposing the whole body to the drugs. This personalized approach can optimize treatment strategies by assessing drug response in the tumor's natural environment, which is not possible with standard treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests a tiny device that releases multiple drugs directly into tumors in patients with a specific type of head and neck cancer. The device helps doctors find out which drugs are most effective by analyzing it after it is removed during surgery.

Research Team

Glenn J. Hanna, M.D

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

An interventional image-guided microdevice implantation and retrieval method for in-vivo drug response assessment. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

NanoNail Gives Drug Response Readouts In Situ. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An implantable microdevice to perform high-throughput in vivo drug sensitivity testing in tumors. [2023]

5. United States 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. [2023]