Trial Summary
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)
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.
12345How 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.
12367Eligibility 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.
+6 more
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.
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Implantable microdevice (IMD) + Biopsy + Standard of Care TreatmentExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana-Farber Cancer InstituteBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Wenxin XuLead Sponsor
References
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]To evaluate the safety and feasibility of implantation and retrieval of a novel implantable microdevice (IMD) in NSCLC patients undergoing operative resection.
An interventional image-guided microdevice implantation and retrieval method for in-vivo drug response assessment. [2020]Recently developed implantable microdevices can perform multi-drug response assessment of cancer drugs in-vivo, with potential to develop highly optimized personalized cancer treatment strategies. However, minimally invasive/interventional image-guided methods of in-vivo microdevice implantation, securement, and retrieval are needed for broad clinical translation. Here we demonstrate proof-of-concept of an interventional microdevice implantation and retrieval method for personalized drug response assessment, using ex-vivo phantom, ex-vivo tissue, and in-vivo murine models.
Microchips and controlled-release drug reservoirs. [2015]This review summarizes and updates the development of implantable microchip-containing devices that control dosing from drug reservoirs integrated with the devices. As the expense and risk of new drug development continues to increase, technologies that make the best use of existing therapeutics may add significant value. Trends of future medical care that may require advanced drug delivery systems include individualized therapy and the capability to automate drug delivery. Implantable drug delivery devices that promise to address these anticipated needs have been constructed in a variety of ways using micro- and nanoelectromechanical systems (MEMS or NEMS)-based technology. These devices expand treatment options for addressing unmet medical needs related to dosing. Within the last few years, advances in several technologies (MEMS or NEMS fabrication, materials science, polymer chemistry, and data management) have converged to enable the construction of miniaturized implantable devices for controlled delivery of therapeutic agents from one or more reservoirs. Suboptimal performance of conventional dosing methods in terms of safety, efficacy, pain, or convenience can be improved with advanced delivery devices. Microchip-based implantable drug delivery devices allow localized delivery by direct placement of the device at the treatment site, delivery on demand (emergency administration, pulsatile, or adjustable continuous dosing), programmable dosing cycles, automated delivery of multiple drugs, and dosing in response to physiological and diagnostic feedback. In addition, innovative drug-medical device combinations may protect labile active ingredients within hermetically sealed reservoirs.
Implantable optical fibers for immunotherapeutics delivery and tumor impedance measurement. [2022]Immune checkpoint blockade antibodies have promising clinical applications but suffer from disadvantages such as severe toxicities and moderate patient-response rates. None of the current delivery strategies, including local administration aiming to avoid systemic toxicities, can sustainably supply drugs over the course of weeks; adjustment of drug dose, either to lower systemic toxicities or to augment therapeutic response, is not possible. Herein, we develop an implantable miniaturized device using electrode-embedded optical fibers with both local delivery and measurement capabilities over the course of a few weeks. The combination of local immune checkpoint blockade antibodies delivery via this device with photodynamic therapy elicits a sustained anti-tumor immunity in multiple tumor models. Our device uses tumor impedance measurement for timely presentation of treatment outcomes, and allows modifications to the delivered drugs and their concentrations, rendering this device potentially useful for on-demand delivery of potent immunotherapeutics without exacerbating toxicities.
NanoNail Gives Drug Response Readouts In Situ. [2023]A tiny drug-eluting device that sits in a brain tumor for the duration of a patient's surgery has shown promise as a clinical tool for guiding personalized treatment decisions. A pilot trial in high-grade gliomas found that the device was safe and could reveal early molecular indicators of drug action.
MEMS fabricated chip for an implantable drug delivery device. [2020]We present a silicon-based implantable drug delivery system (IDDS) for the administration of compounds in vivo. The implanted device contains the drug-filled silicon microchip, control circuitry, telemetry capability, and a battery. At the heart of the IDDS is the drug-containing microchip, a MEMS (MicroElectroMechanical Systems)-based device. A process was developed for the fabrication of the silicon chip. MicroCHIPS' drug release technology has been successfully demonstrated in vitro and in vivo using the therapeutic peptide leuprolide as a model compound.
Solid implantable devices for sustained drug delivery. [2023]Implantable drug delivery systems (IDDS) are an attractive alternative to conventional drug administration routes. Oral and injectable drug administration are the most common routes for drug delivery providing peaks of drug concentrations in blood after administration followed by concentration decay after a few hours. Therefore, constant drug administration is required to keep drug levels within the therapeutic window of the drug. Moreover, oral drug delivery presents alternative challenges due to drug degradation within the gastrointestinal tract or first pass metabolism. IDDS can be used to provide sustained drug delivery for prolonged periods of time. The use of this type of systems is especially interesting for the treatment of chronic conditions where patient adherence to conventional treatments can be challenging. These systems are normally used for systemic drug delivery. However, IDDS can be used for localised administration to maximise the amount of drug delivered within the active site while reducing systemic exposure. This review will cover current applications of IDDS focusing on the materials used to prepare this type of systems and the main therapeutic areas of application.