Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Implantable Microdevice (IMD)

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
Dana-Farber Cancer Institute02215, BostonMassachusetts, United States

Sponsors and collaborators

Oliver Jonas

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Dana-Farber Cancer Institute

Collaborator

Source ClinicalTrials.gov