Drug Screening Using Novel IMD in Renal Cell Carcinoma

June 20, 2023 updated by: Wenxin Xu

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Estimated)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 <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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Combination product: Implantable Microdevice (IMD)

Small, implantable device with 20 microreservoirs for drug and drug combinations, via needle, percutaneously, and guided by interventional radiologic techniques.

Drugs include all or a subset of the following: Cabozantinib, Pazopanib, Lenvatinib, Axitinib, Ipilimumab, Nivolumab, Pembrolizumab, Carboplatin, Paclitaxel, Abemaciclib, Gemcitabine, Everolimus, Belzutifan, Cabozantinib + nivolumab, Cabozantinib + belzutifan, Ipilimumab + nivolumab, Lenvatinib + pembrolizumab, Lenvatinib + everolimus, Abemaciclib + belzutifan, and Tivozanib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Safe Microdevice Procedure
Time Frame: Up to 45 days
Defined by any grade 3-5 adverse event (AE) associated with microdevice placement or retrieval (attribution possible or higher) based on CTCAEv5.
Up to 45 days
Number of Patients with Feasible Microdevice Procedure
Time Frame: 72 hours
Defined as technical success of microdevice placement and microdevice retrieval from the surgery specimen plus having sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenxin Xu

Investigators

  • Principal Investigator: Wenxin Xu, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication.

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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