Drug Screening Using Novel IMD in Renal Cell Carcinoma

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma

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.

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 localized or 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, INR < 1.5 and PTT <1.5x control.
• Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
• The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
• Patient is clinically stable to undergo microdevice implantation and surgical procedures
• Patient has sufficient volume of disease to allow implantation of the microdevice
• Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery
• Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.

Exclusion Criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
• Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).