A Pilot Feasibility, Dose-Escalation Study Using Intracerebral Microdialysis to Assess the Neuropharmacodynamics of Temsirolimus in Patients With Primary or Metastatic Brain Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility of using a microdialysis catheter to assess the neuropharmacodynamics (nPD) of temsirolimus
研究概览
简要总结
RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about how this treatment is used by the body.
PURPOSE: The purpose of this study is to evaluate the feasibility of using a microdialysis catheter to see what effect temsirolimus has on various biological substances associated with brain tumors over time.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of using a microdialysis catheter with a high cut-off membrane to perform neuropharmacodynamics (nPD) assessment of targeted therapy with a mammalian target of rapamycin (mTOR) inhibitor, where nPD is defined as changes in intracerebral levels of vascular endothelial growth factor (VEGF), interleukin-1ß (IL-1ß), and other cytokines.
Secondary
- Assess the relationship between temsirolimus dose and changes in intracerebral levels of VEGF, IL-1ß, and other cytokines.
- Compare changes in intracerebral cytokine levels to changes in systemic cytokine levels.
- Assess the relationship between the degree of microvascular proliferation and the tensin homologue deleted on chromosome 10 (PTEN) status in tumor tissue.
- Assess the relationship between changes in intracerebral cytokine levels after treatment with temsirolimus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Patients do not receive temsirolimus.
干预措施: cytokine levels (Other)
Cohort 2
48 hours after surgery, patients receive one 200 mg dose of temsirolimus IV.
干预措施: temsirolimus (Drug)
Cohort 2
48 hours after surgery, patients receive one 200 mg dose of temsirolimus IV.
干预措施: pharmacological study (Other)
Cohort 2
48 hours after surgery, patients receive one 200 mg dose of temsirolimus IV.
干预措施: cytokine levels (Other)
结局指标
主要结局
Feasibility of using a microdialysis catheter to assess the neuropharmacodynamics (nPD) of temsirolimus
时间窗: Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately
Changes in intracerebral levels of vascular endothelial growth factor (VEGF), interleukin-1ß (IL-1ß), and other cytokines
时间窗: Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately
次要结局
- Relationship between temsirolimus dose and changes in intracerebral levels of VEGF, IL-1ß, and other cytokines(Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately)
- Relationship between the degree of microvascular proliferation and the tensin homologue deleted on chromosome 10 (PTEN) status in tumor tissue(30 days after placement of the microdialysis catheter.)
- Relationship between changes in intracerebral cytokine levels after treatment with temsirolimus(Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately)
- Compare changes in intracerebral cytokine levels to changes in systemic cytokine levels.(Every 6 hours for 96 hours after confirmation that the microdialysis catheter is placed appropriately)