Drug Screening Using Novel IMD in Renal Cell Carcinoma

Status Recruiting

Clinical Trial Summary

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)

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05700461
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact	Wenxin Xu, MD
Phone	617-632-6534
Email	Wenxin_Xu1@dfci.harvard.edu
Status	Recruiting
Phase	Phase 1
Start date	April 24, 2023
Completion date	March 2026

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