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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)
Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Kidney Cancer
Implantable Microdevice (IMD)
Phase 1
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 1 to 6 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 5 people will take part in this research study.}}
Study Type : | Interventional |
Estimated Enrollment : | 5 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma |
Actual Study Start Date : | April 24, 2023 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment 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. |
Combination Product: Implantable Microdevice (IMD) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215