NCT00717275终止2 期
A Phase II Study of Temozolomide (TMZ) Following Stereotactic Radiosurgery (SRS) for Patients With Newly Diagnosed Brain Metastases
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Who Developed Distant Brain Failure at One Year.
研究概览
简要总结
The purpose of this study is to determine if administering temozolomide after completion of stereotactic radiosurgery helps control existing brain metastases and prevents the developement of new brain metastases.
详细描述
Brain metastases represent a heterogenous group of system tumors whose presence in the central nervous system result in profound neurological devastation. Existing therapies for brain metastases are focused on improving both neurologic function and survival. Therapies aimed at controlling the tumor both at the site of the brain metastases and the rest of the brain have the potential to improve outcomes and quality of life. The combined use of stereotactic radiosurgery followed by temozolomide may represent such a strategy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor characteristics adequate for stereotactic radiosurgery:
- •1-3 newly diagnosed, previously untreated, brain metastases
- •Each tumor measuring a size less than or equal to 3 cm
- •No other contraindications to stereotactic radiosurgery
- •Systemic parameters adequate for temozolomide following stereotactic radiosurgery:
- •Histological confirmation of systemic malignancy (brain confirmation not required)
- •Male or female 18 years of age or older
- •Negative pregnancy test (if of childbearing potential)
- •Any number of previous recurrences will be allowed
- •Karnofsky Performance Status > 60
- •Hematocrit > 30,000
- •White blood cell count > 1,500
- •Platelet > 100,000
- •Absolute Neutrophil Count > 1,000
- •Bilirubin < 1.5 x upper limits of normal
- •Transaminases (ALT and AST) < 1.5 x upper limits of normal
- •Creatinine < 1.5 x upper limits of normal
- •Adequate medical health to participate in this study
- •Adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal)
- •Ability to read and understand the informed consent document
- •Ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms
- •No other contraindications to temozolomide (severe organ dysfunction, immunosuppression, etc.)
- •Medical stability and/or recovery from effects of stereotactic radiosurgery
排除标准
- •Karnofsky Performance Status < 60
- •Hematocrit < 30,000
- •White blood cell count < 1,500
- •Platelet < 100,000
- •Absolute Neutrophil Count < 1,000
- •Bilirubin >1.5 x upper limits of normal
- •Transaminases (ALT and AST) > 1.5 x upper limits of normal
- •Creatinine > 1.5 x upper limits of normal
- •Inability to undergo gadolinium-contrasted MRIs, including severe claustrophobia or insufficient allergy prophylaxis
- •Germ cell, leukemia, and lymphoma histologies will be excluded
- •Prior chemotherapy or radiotherapy for brain metastases (prior resection and steroids are allowed)
- •Contraindications to radiosurgery or temozolomide chemotherapy
- •Uncontrolled systemic malignancy
- •Chemotherapy or other systemic therapy for systemic malignancy within a specified time of temozolomide initiation, depending on half-life of agent:
- •Cytotoxic chemotherapy within the previous 4 weeks
- •Nitrosurea (CCNU, BCNU) within the previous 6 weeks
- •Gliadel or temozolomide within the previous 4 weeks
- •Bevacizumab or other antiangiogenic agent within the previous 4 weeks
- •Other targeted molecular or antibody agent within the previous 4 weeks
- •Hormonal agent within the previous 2 weeks
研究组 & 干预措施
Temozolomide
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Number of Participants Who Developed Distant Brain Failure at One Year.
时间窗: 1 Year
次要结局
未报告次要终点
研究者
研究点 (1)
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