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Drug Screening Using Novel IMD in Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Implantable Microdevice (IMD)
Sponsored by
Wenxin Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Suspected Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Patients with Safe Microdevice Procedure
Defined by any grade 3-5 adverse event (AE) associated with microdevice placement or retrieval (attribution possible or higher) based on CTCAEv5.
Number of Patients with Feasible Microdevice Procedure
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.

Secondary Outcome Measures

Full Information

First Posted
January 17, 2023
Last Updated
June 20, 2023
Sponsor
Wenxin Xu
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1. Study Identification

Unique Protocol Identification Number
NCT05700461
Brief Title
Drug Screening Using Novel IMD in Renal Cell Carcinoma
Official Title
Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wenxin Xu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer
Keywords
Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Kidney Cancer, Suspected Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Implantable Microdevice (IMD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients with Safe Microdevice Procedure
Description
Defined by any grade 3-5 adverse event (AE) associated with microdevice placement or retrieval (attribution possible or higher) based on CTCAEv5.
Time Frame
Up to 45 days
Title
Number of Patients with Feasible Microdevice Procedure
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxin Xu, MD
Phone
617-632-6534
Email
Wenxin_Xu1@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenxin Xu, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxin Xu, MD
Phone
617-632-6534
Email
Wenxin_Xu1@dfci.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Drug Screening Using Novel IMD in Renal Cell Carcinoma

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