Early Prediction of Clinical Response to Chemotherapy With FLT-PET
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Response to Chemotherapy Shown in FLT-PET Scans
研究概览
简要总结
This clinical trial studies fluorine F-18 fluorothymidine (FLT)-positron emission tomography (PET) in predicting response to chemotherapy in patients with advanced malignancies. FLT solution can help locate cancer cells inside the body. Diagnostic procedures, such as FLT-PET, may help find tumors and measure a patient's response to treatment.
详细描述
PRIMARY OBJECTIVES:
I. To determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in FLT-PET standardized uptake value which correlates with clinical response.
SECONDARY OBJECTIVES:
I. To determine the relationship between FLT-PET and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity.
OUTLINE:
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
- •Patients actively enrolled and being treated on protocol 2007-0668: Combination Therapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at M.D. Anderson Cancer Center; these patients must have met the inclusion and exclusion criteria for that protocol
- •Women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
- •Ability to understand and the willingness to sign a written informed consent document
- •Patient actively enrolled and being treated on protocol 2012-0061 "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" at M.D. Anderson Cancer Center
排除标准
- •Pregnant or breast-feeding women
- •History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or any component of the formulation
研究组 & 干预措施
Diagnostic (fluorine F-18 fluorothymidine PET)
Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.
干预措施: Fluorothymidine F-18 (Drug)
Diagnostic (fluorine F-18 fluorothymidine PET)
Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.
干预措施: Laboratory Biomarker Analysis (Other)
Diagnostic (fluorine F-18 fluorothymidine PET)
Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Response to Chemotherapy Shown in FLT-PET Scans
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点