NCT00601289撤回2 期
An Open Label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Temozolomide Treatment in Patients With Invasive Pituitary Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Change in Tumor response rate (complete response or partial response) from baseline as assessed by RECIST criteria at 3, 6, 9, and 12 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well temozolomide works in treating patients with invasive pituitary tumors.
详细描述
OBJECTIVES:
Primary
- To assess the effect of temozolomide on pituitary tumor growth in patients with invasive pituitary tumors.
- To assess the effect of temozolomide on pituitary tumor response and the duration of tumor response in these patients.
Secondary
- To assess the effect of temozolomide on pituitary tumor hormone secretion in these patients.
- To assess the effect of temozolomide on other aspects of pituitary function in these patients.
- To assess the overall safety and tolerability of temozolomide in these patients.
- To assess the overall quality of life of patients treated with temozolomide.
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 75 Years（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
Change in Tumor response rate (complete response or partial response) from baseline as assessed by RECIST criteria at 3, 6, 9, and 12 months
时间窗: 1 year
Change from baseline of pituitary tumor control as assessed by MRI at 3, 6, 9, and 12 months
时间窗: 1 year
Rebound tumor growth as assessed by MRI at 6 months after completion of treatment
时间窗: 6 months
次要结局
- Biochemical control as assessed by measurement of hormones secreted in excess by the pituitary tumor at baseline, at 3, 6, 9, and 12 months during treatment, and then at 2 months after completion of treatment(14 months)
- Overall quality of life as assessed by Karnofsky performance status questionnaire periodically during study(1 year)
- Pituitary function as assessed by standard pituitary function tests at baseline and at 6 months and 12 months(1 year)
- Safety and tolerability of temozolomide as assessed by NCI CTC v2.0 at screening, baseline, and then monthly until study completion(1 year)
研究者
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