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)
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 or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against metastatic renal cell carcinoma (RCC). The drugs participants receive will include medications currently used as standard-of-care treatment for metastatic RCC as well as medications currently approved in other cancer types that are under investigation for treatment of RCC. * This study involves planting one or more microdevices, each small enough to fit inside the tip of a needle, into a tumor. The microdevices will release microdoses of cancer drugs via passive diffusion. The drugs will only penetrate the local tumor tissues. * After approximately 3 days, the microdevices and small regions of surrounding tissues will be removed and analyzed. The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, tumor biopsies, and follow up visits. The U.S. Food and Drug Administration (FDA) has not approved the microdevice as a treatment for any disease. The drugs being used have been FDA-approved for the treatment of cancers. Participation in this research study is expected to last up to 4 months. It is expected that about 20 people (10 each in Cohort 1 and Cohor 2) will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Small, implantable device with 20 microreservoirs for drug and drug combinations, via needle, percutaneously, and guided by interventional radiologic techniques. Drugs include all or a subset of the following: Cabozantinib, Pazopanib, Lenvatinib, Axitinib, Ipilimumab, Nivolumab, Pembrolizumab, Carboplatin, Paclitaxel, Abemaciclib, Gemcitabine, Everolimus, Belzutifan, Cabozantinib + nivolumab, Cabozantinib + belzutifan, Ipilimumab + nivolumab, Lenvatinib + pembrolizumab, Lenvatinib + everolimus, Abemaciclib + belzutifan, and Tivozanib. Other medications on the microdevice may be substituted pending updates in clinical and scientific data.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Safety of microdevice implantation
* Any grade 3-5 adverse events likely or definitely attributable to device placement or retrieval * Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes * Any device resulting in major adverse events as defined in the protocol
Time frame: Up to 30 days
Number of Patients with Feasible Microdevice Procedure
For Cohort 1, this is defined as technical success of microdevice placement and successful retrieval of the microdevice from the surgery specimen with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For Cohort 2, feasibility is defined as successful microdevice placement and the successful retrieval of at least one microdevice per patient with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the reservoirs on that microdevice.
Time frame: 72 hours
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