NCT00121420终止2 期
Phase II Trial of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
研究概览
简要总结
The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.
详细描述
Patients will receive three weeks of whole brain radiation therapy concurrent with daily motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost concurrent with motexafin gadolinium. Patients will be followed for radiologic response, neurologic progression, and neurocognitive progression.
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
- •Age ≥ 18 years
- •Karnofsky performance status (KPS) ≥ 70
- •Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases
- •Each patient must sign a study-specific Informed Consent form
排除标准
- •Previous cranial radiation
- •Complete resection of all known brain metastases
- •Known leptomeningeal metastases
- •Known liver metastases
- •Clinical or radiologic evidence of progression (other than study lesion[s) within 1 month prior to enrollment
- •Patients with metastases within 10 mm of the optic apparatus
- •Patients with metastases in the brainstem, midbrain, pons, or medulla
- •Planned chemotherapy during WBRT and/or SRS
- •Uncontrolled hypertension
- •Women who are pregnant or lactating
- •and Laboratory values as follows:
- •LDH > 1.3 x upper limit of normal (ULN)
- •ANC < 1500/mm3
- •Platelets < 50,000/mm3
- •Creatinine > 2.0 mg/dL
- •AST or ALT > 3 x ULN
- •Total bilirubin > 2 x ULN
结局指标
主要结局
Rate of irreversible Grade 3 or any Grade 4 or 5 neurologic radiation toxicities occuring within 3 months following SRS boost
次要结局
- Change in lesion size and number between screening MRI and SRS treatment -planning MRI
- Time to neuroligic progression or death with evidence of neurologic progression
- Time to neurocognitive progression
研究者
研究点 (12)
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