Drug Screening Using Novel IMD in Renal Cell Carcinoma

Last updated: June 20, 2023
Sponsor: Wenxin Xu
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Cancer/tumors

Kidney Cancer

Treatment

Implantable Microdevice (IMD)

Clinical Study ID

NCT05700461
22-492
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients must have the ability to understand and the willingness to sign a writteninformed consent document.
  • Participants must have confirmed or suspected metastatic renal cell carcinoma, andmust be planned for either nephrectomy or metastatectomy as part of their clinicalcare. 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 theclinically appropriate treatment strategy based on clinical history and extent ofdisease.
  • Patients must be deemed medically stable to undergo both percutaneous procedures andstandard-of-care surgical procedures.
  • Participants will undergo laboratory testing within 30 days prior to the procedure (orwithin 72 hours if there has been a change in the clinical status since the initialblood 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 andallows the research team to assess for study eligibility. This will have been done aspart of the standard-of-care.
  • The participant's case must be reviewed by representatives of interventional radiologyand the appropriate surgical subspecialty to assess the following factors:
  • Patient is clinically stable to undergo microdevice implantation and surgicalprocedures
  • Patient has sufficient volume of disease to allow implantation of the microdevice
  • Patient has a lesion for which the microdevice is a) amenable to percutaneousplacement, and b) amenable to removal at the time of surgery
  • Patients must be willing to undergo research-related genetic sequencing (somatic andgermline) and data management, including the deposition of de-identified geneticsequencing data in NIH central data repositories.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Implantable Microdevice (IMD)
Phase: 1
Study Start date:
April 24, 2023
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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