NCT00667901终止1 期
A Phase 0 Trial of Riluzole in Patients With Resectable Stage III and IV Melanoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Measurement of the inhibition of components of the Grm1 signaling cascade
研究概览
简要总结
RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.
PURPOSE: This early phase I trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To evaluate the potential effects of glutamate receptor blockade on cellular pathways important in the genesis and progression of melanoma in patients with stage III or IV melanoma undergoing surgical resection.
- To determine whether treatment with riluzole alters expression of activated PLC and ERK in lysates from tumor tissue biopsies.
Secondary
- Determine if treatment with riluzole affects the overall metabolic activity of melanoma tumors as measured by pre- and post-treatment PET scanning, pre- and post-treatment tumor mitotic rate evaluation, and pre- and post-treatment immunohistochemical staining for Ki-67.
研究设计
- 研究类型
- Interventional
- 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
结局指标
主要结局
Measurement of the inhibition of components of the Grm1 signaling cascade
次要结局
- Mitoses in nodal metastases and Ki-67 immunostaining (0-3+ scale)
研究者
研究点 (2)
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