NCT00080054已完成1 期
Phase I Trial of Motexafin Gadolinium (MGd) in Combination With Temozolomide for Treatment of Malignant Gliomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to find out about the safety of adding the investigational drug motexafin gadolinium to a standard course of chemotherapy with temozolomide for patients with malignant glioma. Secondly, the study will determine how many patients will respond to this treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Histologically confirmed diagnosis of malignant gliomas that requires systemic antineoplastic treatment. Malignant glioma is defined as any of the following: Glioblastoma multiforme (GBM); Anaplastic astrocytoma (AA); Anaplastic oligodendroglioma; Anaplastic mixed glioma; Glioma not otherwise specified (except low-grade glioma)
- •ECOG performance status score of 0, 1, or 2
- •Each patient must sign a study-specific informed consent form
排除标准
- •Laboratory values of:
- •Absolute neutrophil count < 2000/µL
- •Platelet count < 100,000/µL
- •AST or ALT > 2 x the upper limit of normal (ULN)
- •Alkaline phosphatase > 5 x ULN
- •Bilirubin > 2 x ULN
- •Creatinine > 2.0 mg/µL
- •Plan to use any additional cancer therapy (e.g., systemic, radiation, surgery) during the study period
- •Women who are pregnant or lactating
研究者
研究点 (2)
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