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

Trial Summary

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 data supports the effectiveness of the treatment Implantable Microdevice (IMD) for kidney cancer?

Research on implantable microdevices shows they can safely test how well different cancer drugs work directly inside the body, which helps in creating personalized treatment plans. This approach has been tested in lung cancer and other tumor models, suggesting it could be useful for kidney cancer as well. ^{1 2 3 4 5}

How is the Implantable Microdevice (IMD) treatment for kidney cancer different from other treatments?

The Implantable Microdevice (IMD) is unique because it allows for localized, controlled drug delivery directly at the tumor site, enabling personalized cancer treatment by assessing multiple drug responses in vivo (inside the body). This approach contrasts with traditional systemic treatments that often involve oral or injectable drugs, which can lead to fluctuating drug levels and broader systemic exposure. ^{1 2 3 6 7}

What is the purpose of this trial?

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 drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC). The name of the intervention(s) involved in this study are: * Implantable Microdevice (IMD) * Surgery (excision of tumor) * Drugs used in this study will only include drugs already used as standard of care for the treatment of metastatic renal cell carcinoma (RCC)

Research Team

Wenxin Xu, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. 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]

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

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

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

Microchips and controlled-release drug reservoirs. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Implantable optical fibers for immunotherapeutics delivery and tumor impedance measurement. [2022]

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

NanoNail Gives Drug Response Readouts In Situ. [2023]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

Solid implantable devices for sustained drug delivery. [2023]