Testing a microdevice for drug delivery in kidney cancer
Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma
This study is testing a tiny device that delivers small amounts of cancer drugs directly to kidney tumors to see if it helps people with advanced kidney cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05700461 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed or suspected metastatic renal cell carcinoma who are scheduled for surgical tumor removal.
Not a fit: Patients who do not have metastatic renal cell carcinoma or those who are not planned for surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment options for patients with metastatic renal cell carcinoma.
How similar studies have performed: While the use of microdevices for localized drug delivery is a novel approach, similar studies have shown promise in other cancer types, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.