NCT00903214撤回1 期
Metabotropic Glutamate Receptor-1 (mGluR1): Validation of a Serendipitously Discovered Molecular Target for Breast Cancer Treatment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer. Riluzole may help slow the growth of tumor cells.
PURPOSE: This phase I trial is studying riluzole in women with stage I, stage II, or stage IIIA breast cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the effects of glutamate receptor blockade with riluzole on cellular pathways important in the genesis and progression of disease in women with stage I-IIIA breast cancer by examining components of the mGluR1 signaling pathway in the pre- and post-treatment tumor samples to determine if glutamate blockade affects signaling through this pathway.
Secondary
- To determine whether treatment with riluzole affects the proliferation and apoptosis in a manner suggesting a potential for therapeutic effectiveness.
- To determine whether treatment with riluzole causes objectively measurable tumor shrinkage.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Inhibition of downstream targets of the mGluR1 signaling cascade, specifically downregulation of PLCβ activity
时间窗: Pre and Post-treatment with RILUTEK® (riluzole) administration
Downregulation of phosphorylated ERK1/2
时间窗: Pre and Post treatment with RILUTEK® (riluzole) administration:
次要结局
- Measures of proliferation, specifically mitotic rate and expression of Ki-67(Pre and Post treatment with RILUTEK® (riluzole) administration:)
- Measures of apoptosis, specifically levels of poly(ADP-ribose) polymerase (PAPR) cleavage and caspase III activity(Pre and Post treatment with RILUTEK® (riluzole) administration:)
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