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IMD Drug Screening for Kidney Cancer

Phase 1

Recruiting

Led By Wenxin Xu, MD

Research Sponsored by Wenxin Xu

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures

Must not have

Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a microdevice that releases small doses of cancer drugs to test their effectiveness against RCC. Surgery and existing cancer drugs are also involved.

Who is the study for?

This trial is for adults with metastatic renal cell carcinoma who are stable enough for surgery and have a tumor at least 1cm in size. They must be evaluated by an oncologist, have certain blood count levels, and agree to genetic testing. People with uncontrolled illnesses or bleeding disorders that increase surgical risks can't participate.

What is being tested?

The study tests the safety of implanting and retrieving a microdevice (IMD) that releases tiny amounts of cancer drugs into kidney tumors. The IMD contains 19 drugs used in standard care, aiming to find the most effective treatment strategy for each patient.

What are the potential side effects?

While specific side effects aren't listed, potential risks may include those associated with surgical procedures such as infection, bleeding, or reaction to anesthesia; and any known side effects of the standard RCC medications contained within the IMD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to have my genetic information used for research and stored anonymously.

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I am medically fit for surgery and other procedures.

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I have kidney cancer that has spread, and surgery to remove it is planned.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a bleeding or clotting disorder that makes surgery risky.

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I do not have any severe illnesses that would make surgery or biopsy unsafe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients with Feasible Microdevice Procedure

Number of Patients with Safe Microdevice Procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Implantable microdevice (IMD) + Biopsy + Standard of Care TreatmentExperimental Treatment1 Intervention

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.

0 / 6Eligibility criteria met