Testing a microdevice for drug delivery in kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot research evaluates the safety and feasibility of an implantable microdevice that releases microdoses of 19 specific cancer drugs directly into tumors for patients with metastatic renal cell carcinoma. Participants will have the microdevices implanted during a surgical procedure, and after three days, the devices along with surrounding tissue will be retrieved for analysis. The drugs used are standard treatments for kidney cancer and are administered locally to assess their effectiveness. The study aims to gather data on how well these drugs work in a targeted manner against the cancer.

Why it matters

Who can join: the full rules

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 localized or 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, 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).

Where it's running

• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Wenxin Xu, MD — Dana-Farber Cancer Institute
• Study coordinator: Wenxin Xu, MD
• Email: Wenxin_Xu1@dfci.harvard.edu
• Phone: 617-632-6534

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining sasanlimab, palbociclib, and axitinib for metastatic kidney cancer

  This test tries a combination of sasanlimab, palbociclib, and axitinib in people with advanced or metastatic clear cell or translocation renal cell carcinoma to see if it works and is safe.

  Recruiting at 2 sites Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT07123090

• Olaparib treatment for patients with metastatic kidney cancer and specific gene mutations

  This study is testing if the oral medication olaparib can help people with advanced kidney cancer who have certain gene mutations and have already tried other treatments.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT03786796

• Your Kidney Cancer Immunotherapy: How You Get It and If Labs Can Be At Home

  This study tests whether people with kidney cancer prefer intravenous or subcutaneous immunotherapy and whether at‑home lab draws plus telehealth visits before treatment are practical.

  Recruiting at 7 sites Phase 4 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07872553

• Neoadjuvant HIF-2α inhibitor with or without PD-1 antibody for resectable clear cell kidney cancer

  This trial tests whether casdatifan alone or combined with zimberelimab can shrink tumors in people with resectable clear cell kidney cancer before surgery.

  Recruiting at 2 sites Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts and 2 other locations · NCT07397611

• Evaluating a new CAR T-cell therapy for solid tumors expressing EGFR

  This study is testing a new CAR T-cell therapy to see if it can safely help adults with certain solid tumors, like colorectal and lung cancer, that have specific markers.

  Recruiting at 10 sites Phase 1/2 A2 Biotherapeutics Inc. · Gilbert, Arizona and 9 other locations · NCT06682793

• Using a digital tool to improve kidney surgery planning

  This study is testing a new digital tool to see if it helps doctors plan kidney surgery better for patients with localized kidney cancer compared to just using regular CT scans.

  Recruiting at 5 sites University Hospital, Ghent · Aalst and 4 other locations · NCT06536439

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.