Feasibility of Assessing Lymphoma Response to Precise Local Injection of Candidate Chemotherapy Agents Using the CIVO(tm) Microdosing System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Evaluation of the response to locally injected drugs
研究概览
简要总结
Many cancer patients are prescribed drugs to which their cancer is already resistant - and thus suffer toxicity with no potential for benefit. Previous attempts to assess chemoresistance or sensitivity in vitro have failed. This is a feasibility study in human patients with newly diagnosed or recurrent lymphoma to determine how human cancerous lymph nodes in situ respond to standard of care therapeutics precisely microinjected with the CIVO(tm) microdosing system.
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
- •Has enlarged lymph node(s) highly suspicious of lymphoma; or has been diagnosed with lymphoma but is untreated; or has persistent recurrent, or progressive lymphoma
- •At least one enlarged lymph node that is considered accessible for percutaneous injection by the investigator and that is at least 2 cm in longest dimension.
- •ECOG performance status of 0-2 (or a Karnofsky performance status of >50%).
- •Labs required for enrollment: Absolute neutrophil count > 1000/mm3, platelet count > 50,000/mm3, hematocrit > 25%, creatinine <3.0 mg/dl, total bilirubin <4.0 mg/dl, SGOT and SGPT less than five times the institutional upper limits of normal.
排除标准
- •Lymphoma patients in which the delay of surgery until the lymph node resection date or other factors associated with the study are not feasible.
- •Patients with central nervous system disease.
- •Any therapy that is potentially immunosuppressive or has anticancer activity in the 4 weeks prior to device microinjection.
- •Patients with active fungal, viral, or bacterial infections
- •Pregnant women.
- •Inability to give informed consent.
研究组 & 干预措施
Multiple drug microinjection
Multiple drug microinjection with locally injected rituximab, vincristine, doxorubicin, bendamustine, prednisolone, or a combination of them
干预措施: Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them (Drug)
结局指标
主要结局
Evaluation of the response to locally injected drugs
时间窗: 1-3 days post injection after injection
次要结局
- Evaluate the safety profile of multiple simultaneous microinjections using custom syringe(up to 28 days)