IMD Drug Screening for Kidney Cancer

Overseen By Wenxin Xu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Wenxin Xu

Disqualifiers: Active infection, Heart failure, Angina, others

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

Compensation: Varies

Number of Visits: 3

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small device called the Implantable Microdevice (IMD), which releases tiny doses of cancer drugs directly into kidney tumors. The aim is to determine which drugs work best against metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The trial seeks to establish whether this method is safe and effective in identifying the right treatment for these tumors. Individuals diagnosed with metastatic renal cell carcinoma and scheduled for tumor removal surgery might be suitable candidates. Participants will have the device placed in their tumor before surgery, and it will be removed along with the tumor. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance 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 whether you need to stop taking your current medications. It is best to discuss this with the medical team conducting the trial.

What prior data suggests that this implantable microdevice is safe for use in humans?

Research shows that the implantable microdevice (IMD) used in this study is generally well-tolerated. Previous patients demonstrated that the device can be safely inserted and removed. The IMD releases tiny amounts of cancer drugs directly into the tumor, helping doctors understand how the tumor responds. Because these doses are very small, the risk of side effects is lower.

The drugs used with the IMD are standard treatments for kidney cancer, meaning they are approved and known to be safe for this type of cancer. The study mainly focuses on the safety of the microdevice itself, not the drugs it delivers.

Overall, studies so far have not reported any major safety concerns with the use of the IMD, suggesting that the IMD is a safe way to deliver cancer drugs directly into the tumor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Implantable Microdevice (IMD) is unique because it offers a new way to directly assess how kidney cancer tumors respond to different treatments on an individual basis. Unlike traditional approaches that often involve systemic treatment with drugs like tyrosine kinase inhibitors or immunotherapy, the IMD is placed directly into the tumor to test multiple therapies simultaneously. This method allows for precise, personalized treatment planning based on how the tumor actually reacts to various drugs, potentially leading to more effective and tailored treatment strategies. Researchers are excited about the IMD because it could significantly enhance the ability to select the most promising treatment options for each patient, improving outcomes and minimizing unnecessary side effects.

What evidence suggests that the Implantable Microdevice (IMD) is effective for evaluating cancer drugs against metastatic renal cell carcinoma?

Research has shown that small devices placed inside the body, called implantable microdevices (IMDs), could help treat advanced kidney cancer. In this trial, participants will receive IMDs, which release tiny amounts of cancer drugs directly into the tumor. This allows doctors to observe how the tumor responds to different treatments. Early results suggest that IMDs might help doctors choose the best drug for each patient, potentially leading to better treatment outcomes. Although this method is still under study, initial research supports its potential to make cancer treatment more precise and effective. ^{1 2 3 5 6}

Who Is on the Research Team?

Wenxin Xu, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with metastatic renal cell carcinoma who are stable enough for surgery and have a tumor at least 1cm in size. They must be evaluated by an oncologist, have certain blood count levels, and agree to genetic testing. People with uncontrolled illnesses or bleeding disorders that increase surgical risks can't participate.

Inclusion Criteria

A cancer specialist has reviewed my case to decide on the best treatment plan.

I agree to have my genetic information used for research and stored anonymously.

Before the procedure, you need to have recent blood tests to show that your white blood cell and platelet counts are normal, and that your blood clotting time is not too long.

Exclusion Criteria

I do not have a bleeding or clotting disorder that makes surgery risky.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Implantation and Initial Evaluation

Placement of 1-6 microdevices into the tumor, followed by surgical removal and analysis after approximately 3 days

1 week

1 visit (in-person)

Standard of Care Treatment

Participants undergo standard of care surgery and receive standard cancer treatment drugs

Up to 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 45 days

1 follow-up clinic visit

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Microdevice (IMD)

Trial Overview

The study tests the safety of implanting and retrieving a microdevice (IMD) that releases tiny amounts of cancer drugs into kidney tumors. The IMD contains 19 drugs used in standard care, aiming to find the most effective treatment strategy for each patient.

How Is the Trial Designed?

Group I: Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment Experimental Treatment 1 Intervention

Participants with confirmed or suspected metastatic Renal Cell Carcinoma (RCC) and who are candidates for standard of care metastatectomy or debulking/consolidative nephrectomy will be selected for study participation and will undergo study procedures as outlined: * Placement of 1-6 microdevice(s) 72 +/- 24 hours prior to scheduled, standard of care surgery. The number of microdevices implanted into a tumor will be made on a case-by-case basis based on tumor and participant factors before and during the procedure. * At the time of standard of care surgery, surgical removal of microdevice(s) along with surrounding tumor tissue. * Monitoring for safety endpoints during inpatient stay and at a follow-up clinic visit.

Who Is Running the Clinical Trial?

Wenxin Xu

Lead Sponsor

Trials

1

Recruited

5+

Published Research Related to This Trial

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]

The study introduces an innovative implantable device that combines local delivery of immune checkpoint blockade antibodies with photodynamic therapy, which enhances anti-tumor immunity while minimizing systemic toxicities.

This device allows for real-time monitoring of tumor response and the ability to adjust drug delivery, making it a promising solution for improving the efficacy and safety of cancer immunotherapy over extended treatment periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable optical fibers for immunotherapeutics delivery and tumor impedance measurement. Chin, AL., Jiang, S., Jang, E., et al.[2022]

Implantable microchip-based drug delivery devices are being developed to improve the safety and efficacy of medication administration by allowing for precise, on-demand dosing directly at the treatment site.

These advanced devices utilize recent technological advancements in micro- and nanoelectromechanical systems (MEMS or NEMS) to enable features like programmable dosing cycles and automated delivery of multiple drugs, addressing unmet medical needs in individualized therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microchips and controlled-release drug reservoirs. Staples, M.[2015]

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]

Implantable drug delivery systems (IDDS) offer a promising alternative to traditional oral and injectable drug administration by providing sustained drug delivery, which is particularly beneficial for chronic conditions where patient adherence is often a challenge.

IDDS can deliver drugs locally to the targeted area, maximizing therapeutic effects while minimizing systemic exposure, thus enhancing the overall safety and efficacy of treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solid implantable devices for sustained drug delivery. Magill, E., Demartis, S., Gavini, E., et al.[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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11301863/

29 Pilot study of an implantable microdevice forin vivo ...

Conclusions. Implantation of microdevices in RCC tumors may be a useful approach to improve treatment selection and accelerate drug development ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05700461

Drug Screening Using Novel IMD in Renal Cell Carcinoma

This Pilot research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs ...

3.

researchgate.net

researchgate.net/publication/382935757_29_Pilot_study_of_an_implantable_microdevice_for_in_vivo_evaluation_of_drug_response_in_renal_cell_carcinoma_NCT05700461

29 Pilot study of an implantable microdevice for in vivo ...

We are conducting a trial to evaluate the safety and feasibility of IMD implantation in RCC tumors and subsequent collection of drug response data on targeted, ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03406

Implantable Microdevice for the Delivery of Microdoses ...

This phase I clinical trial tests the safety and effectiveness of an implantable microdevice to deliver a smaller amount of drugs (microdose) to the tumor ...

5.

kcrs.kidneycan.org

kcrs.kidneycan.org/wp-content/uploads/2024/07/29_Wenxin_Xu.pdf

Pilot study of an implantable microdevice for in vivo ...

IMDs deliver microdoses of up to 20 different drugs and/or combinations into RCC tumors, allowing in vivo assessment of tumor response to drugs in the patient's ...

6.

dana-farber.org

dana-farber.org/clinical-trials/22-492

Pilot study of an implantable microdevice for in situ ...

This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 19 specific drugs or ...