Thalomid and Carboplatin for the Treatment of Pediatric Brain Stem Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 11
- 主要终点
- To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
研究概览
简要总结
Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin. Thalidomide has been available for many years and has been used to treat many different illnesses. Carboplatin is an effective medicine in killing cancer cells. Thalidomide works by blocking angiogenesis (the process of new blood vessel formation). If a tumor does not have blood vessels providing oxygen and nutrients, it will not be able to grow. This research will look at how combining the effects of thalidomide (preventing tumor growth) with the tumor killing effect of carboplatin effects the long-term outlook for patients with these tumors.
This study will try to find out how well Thalomid™ and carboplatin combined with radiation therapy works in treating children newly diagnosed with brain stem glioma. This study will look at how well Thalomid ™ and carboplatin work in patients with recurrent brain stem glioma. This study will also look at any side effects of these treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Patients must be \>/= 3 and \ 6 weeks.
- •* Patients must have adequate hematologic and renal function: ANC \>1,000/ul, platelets\>100,000/ul and creatinine normal for age: \
排除标准
- 未提供
结局指标
主要结局
To determine the overall survival and progression free survival of patients with recurrent brain stem glioma.
To determine the toxicity of this drug regimen.
To determine overall and event free survival for newly diagnosed brain stem glioma with the protocol regimen.
次要结局
- To determine whether the multi-agent chemotherapy regimen of thalidomide and carboplatin, in patients with recurrent brain stem gliomas will extend their survival as compared to historical controls.
- To formulate experimentally derived hypothesis in order to establish a basis for future investigational studies.
研究者
Stewart Goldman
Division Head
Ann & Robert H Lurie Children's Hospital of Chicago