NCT00253461终止早期 1 期
Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian, Small Cell Lung, or Other Cancer
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Pharmacokinetics on day of positron-emission tomography scan
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.
详细描述
OBJECTIVES:
Primary
- Determine if tumor uptake of ^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.
- Determine, preliminarily, if ^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.
Secondary
- Determine the whole-body biodistribution of ^11C topotecan in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian cancer, small cell lung cancer, or other cancers
- •Metastatic brain disease
- •Eligible for topotecan therapy
- •Measurable disease by CT scan and/or MRI
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Not specified
- •Creatinine clearance ≥ 50 mL/min
- •Not pregnant or nursing
- •Adequate end-organ function
- •Able to tolerate lying on a radiology table for ≥ 1 hour
- •No serious medical or psychiatric illness that would preclude study compliance or giving informed consent
- •PRIOR CONCURRENT THERAPY: Not specified
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics on day of positron-emission tomography scan
时间窗: Within 1 week of PET
Disease response
时间窗: after 1-2 courses of treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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