Feasibility of Assessing Drug Response to Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma Patients Undergoing Surgery.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs
研究概览
简要总结
This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
详细描述
This is a single arm, pilot study designed to test the feasibility of using the CIVO (Comparative In Vivo Oncology) system in patients with soft tissue sarcoma accessible for percutaneous injection. Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single solid tumor. Following the patient's biopsy surgery or tumor resection surgery, the injected portion and a small uninjected portion will be used to determine the in situ drug response in the tumor. None of the data from this evaluation will be shared with patients or used to make clinical decisions. Study clinicians will have access to the patient's health record for 1 year after the study to monitor patient treatment responses. Such information will be used to help evaluate the correlation between clinical response and tumor response assessed via CIVO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •18 years of age or over.
- •At least one suspected soft tissue sarcoma tumor that is considered by the investigator to be: (1) accessible for percutaneous injection and (2) at least 2.5 cm in shortest dimension for patients undergoing an incisional biopsy, or at least 3 cm in shortest dimension for patients undergoing an excisional biopsy/tumor resection. Tumors should not be selected if the Investigator believes them to be necrotic or exhibit signs of radiation-induced fibrosis.
- •Prior surgical evaluation and plan for surgical biopsy or surgery to remove the tumor being injected.
- •ECOG performance status of 0-2 (or a Karnofsky performance status of >50%)
- •Labs required for enrollment (prior to microinjection):
- •Absolute neutrophil count > 1000/mm3
- •Platelet count > 50,000/mm3
- •Hematocrit > 25%
- •Creatinine <3.0 mg/dl
- •Total Bilirubin <4.0 mg/dl
- •Bilirubin <4.0 mg/dl, SGOT ≤ 1.5 times the upper limit of normal
- •PT and PTT ≤ 1.5 times the upper limit of normal
排除标准
- •Subjects with active fungal, viral, or bacterial infections.
- •Pregnant women.
- •Inability to give informed consent.
- •Current treatment with anticoagulation such as warfarin or low-molecular-weight heparin.
- •Tumors near critical structures such as those located near or in the brain or spine. This assessment will be determined by the treating clinician.
研究组 & 干预措施
Multiple drug microinjection
Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single enlarged solid tumor.
干预措施: Multiple drug microinjection (Drug)
Multiple drug microinjection
Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected 4 to 72 hours prior to surgery using the CIVO device. Minute volumes (up to 8.3 microliters) of saline (negative control) or microdoses of anti-cancer agents will be percutaneously injected in a columnar fashion through each of 8 needles into a single enlarged solid tumor.
干预措施: CIVO device (Device)
结局指标
主要结局
Quantification of fraction of cells positive for apoptosis and drug target engagement biomarkers around injected drugs
时间窗: 4-72 hours after microinjection
Analysis will be performed to determine if there is a difference in responses caused by each drug versus the vehicle control
次要结局
- Coefficient of variation and intra-class correlation coefficient of fraction of cells around injected drug in multiple tumor planes(4-72 hours after microinjection)
- Number of patients with adverse events related to pain(up to 28 days after microinjection)