Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Response in Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Patients with Feasible Microdevice Procedure
研究概览
简要总结
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)
详细描述
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 one or more 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Implantable microdevice (IMD) + Biopsy + Standard of Care Treatment
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.
干预措施: Implantable Microdevice (IMD) (Combination Product)
结局指标
主要结局
Number of Patients with Feasible Microdevice Procedure
时间窗: 72 hours
For Cohort 1, this is defined as technical success of microdevice placement and successful retrieval of the microdevice from the surgery specimen with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For Cohort 2, feasibility is defined as successful microdevice placement and the successful retrieval of at least one microdevice per patient with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the reservoirs on that microdevice.
Safety of microdevice implantation
时间窗: Up to 30 days
* Any grade 3-5 adverse events likely or definitely attributable to device placement or retrieval * Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes * Any device resulting in major adverse events as defined in the protocol
次要结局
未报告次要终点
研究者
Oliver Jonas
Associate Professor
Brigham and Women's Hospital