Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging
研究概览
简要总结
This pilot research trial studies the effects of dexamethasone in patients with non-small cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive substance to show changes in tumor cells. Studying the effects of dexamethasone on lung tumors using FLT positron emission tomography may help doctors plan better treatments.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the effect of dexamethasone (Dex) treatment in patients with relapsed non-small cell lung cancer (NSCLC) using 3'-fluorothymidine (FLT) positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax).
SECONDARY OBJECTIVES:
I. Assess the reversibility of Dex-mediated changes in tumor FLT retention following the withdrawal of Dex.
II. Measure tumor Glucocorticoid Receptor alpha expression (GRα) from recent patient biopsy samples.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically or cytologically proven advanced non-squamous NSCLC. Patients may have newly diagnosed recurrent progressive or refractory disease which may be localized or wide spread.
- •No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter).
- •Life expectancy of greater than 4 weeks
- •Absolute neutrophil count >= 1,000/mcL (measured within 2 weeks of registration)
- •No history of human immunodeficiency virus (HIV) or active infections
- •No history of diabetes
- •No surgery in the last 2 weeks prior to study enrollment
- •Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
- •Ability to understand and the willingness to sign a written informed consent document
- •Agreed to FLT-PET imaging and signed consent and eligible FLT-PET protocol 2006-127
- •Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University
排除标准
- •Patients must have measureable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance [MR] or PET); lesions in the previously irradiated area can be considered as measureable lesions as long as there has been an increase of at least 10 mm when compared to measurements obtained after completion of radiation
研究组 & 干预措施
Treatment (dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
干预措施: Dexamethasone (Drug)
Treatment (dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
干预措施: Device for PET (Device)
Treatment (dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (dexamethasone, 18F-FLT PET)
Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging
时间窗: Baseline to day 9
The primary endpoint is reported with mean and standard deviation
次要结局
- Fold Change in Senescence Marker Gro-alpha(Baseline to day 9)
- Fold Change in Senescence Marker Gro-beta(Baseline to day 9)
- Fold Change in Senescence Marker MCP-1(Baseline to day 9)
- Tumor Glucocorticoid Receptor Alpha Expression(Baseline)
研究者
Anthony F. Shields, MD PhD
Principal Investigator
Barbara Ann Karmanos Cancer Institute