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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 \<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.

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Wenxin Xu, MD
Wenxin_Xu1@dfci.harvard.edu
617-632-6534
Time Frame
Start Date: 2023-04-24
Estimated Completion Date: 2026-03
Participants
Target number of participants: 5
Treatments
Experimental: Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment
Participants with confirmed or suspected metastatic Renal Cell Carcinoma (RCC) and who are candidates for standard of care metastatectomy or debulking/consolidative nephrectomy will be selected for study participation and will undergo study procedures as outlined:~* Placement of 1-6 microdevice(s) 72 +/- 24 hours prior to scheduled, standard of care surgery. The number of microdevices implanted into a tumor will be made on a case-by-case basis based on tumor and participant factors before and during the procedure.~* At the time of standard of care surgery, surgical removal of microdevice(s) along with surrounding tumor tissue.~* Monitoring for safety endpoints during inpatient stay and at a follow-up clinic visit.
Related Therapeutic Areas
Sponsors
Leads: Wenxin Xu

This content was sourced from clinicaltrials.gov

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