Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Nivolumab

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Lenvatinib

Everolimus

Belzutifan

Axitinib

Ipilimumab

Tivozanib

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.

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.

Implantable Microdevice (IMD)

Wenxin Xu, MD

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)

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.

Drug Screening Using Novel IMD in Renal Cell Carcinoma

Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma

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.

Defined by any grade 3-5 adverse event (AE) associated with microdevice placement or retrieval (attribution possible or higher) based on CTCAEv5.

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.

Wenxin Xu

Principal Investigator

Spots Global Cancer Trial Database for suspected renal cell carcinoma