Drug Screening Using Novel IMD in Renal Cell Carcinoma

Introduction

• Org Study ID: 22-492
• NTC ID: NCT05700461
• Lead Sponsor Name: Dana-Farber Cancer Institute
• Status: RECRUITING

Conditions

• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma
• Translocation/TFE Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma

Brief 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)

Eligibility Criteria

Inclusion Criteria:

* Patients must have the ability to understand and the willingness to sign a written informed consent document.
* Participants must have confirmed or suspected metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
* Participants must be 18 years of age or older.
* Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
* Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
* Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, PT (INR) 1.5 and PTT