Pilot Study Using an Implantable Microdevice to Test Cancer Drug Effects in Kidney Cancer Evaluation of Safety and Feasibility in Metastatic Renal Cell Carcinoma Treatment

What this Trial Is About

Researchers are studying the safety and feasibility of implanting and removing a tiny device that releases small doses of 19 different cancer drugs or drug combinations to help evaluate how these drugs work against metastatic renal cell carcinoma RCC. This pilot research involves drugs already used as standard care for metastatic RCC and some approved for other cancers but being tested for RCC. The study aims to provide a new tool to assess drug effectiveness directly within tumors. The study involves placing one or more microdevices, each small enough to fit inside a needle tip, into tumors. These devices release microdoses of drugs locally into tumor tissue by passive diffusion. After about three days, the microdevices and surrounding tumor tissue are surgically removed during a standard-of-care operation. Participants will receive standard treatments for metastatic RCC alongside the implant procedure. The process includes implantation 72 hours before surgery and surgical removal of the device and tissue at surgery time. Participants will undergo screening, imaging, blood tests, tumor biopsies, and follow-up visits over approximately four months. Researchers will monitor safety during hospital stays and follow-up visits, focusing on safety of device implantation and procedure feasibility within 30 days and 72 hours respectively. Data from tumor tissue and drug response will be analyzed. The study expects about 20 participants to take part in two cohorts, with monitoring continuing after surgery to ensure safety and collect outcome data.

Drug Screening Using Novel IMD in Renal Cell Carcinoma