Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
Lay abstract: Study Purpose With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.
The primary aim of this study is:
To obtain pilot safety data on the use of simvastatin in young adults treated for HD.
The secondary aims of this study are:
To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.
To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.
To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.
研究概览
详细说明
With contemporary combined modality therapy the expected longterm survival of children and adolescents with Hodgkin's disease (HD) is exceedingly high. Thus, the emphasis for future therapeutic interventions must include attention to the late effects of therapy. The development of cardiovascular disease as a late effect of radiation therapy has been well described and documented. Our recent pilot study of child and young adult HD survivors revealed significant subclinical atherosclerosis as evidenced by increased Carotid Artery Intima Media Thickness (CIMT) compared to controls. The higher CIMT values were positively associated with increasing age, total cholesterol, LDLcholesterol and diastolic BP. This finding was present in children and young adults who had received no or low dose radiation suggesting that chemotherapy or the disease process itself contributes to the development of atherosclerosis and risk for cardiovascular disease. Numerous studies have shown HMG CoA reductase inhibitors ("statins") to be effective in reducing the progression of atherosclerosis in adults. These agents have been studied in children and young adults for over a decade.
The primary aim of this study is:
To obtain pilot safety data on the use of simvastatin in young adults treated for HD.
The secondary aims of this study are:
To obtain pilot data on the effect of simvastatin on subclinical carotid artery atherosclerosis as measured by Carotid Artery IMT in young adults treated for HD.
To obtain pilot data on the effect of simvastatin on markers of inflammation measured in the serum of young adults treated for HD.
To obtain pilot data to serve as the basis for the development of a multicenter randomized study for the use of simvastatin in survivors of HD.
We will do this by enrolling patients diagnosed with HD and evaluating the safety of simvastatin as evidenced by laboratory measures
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10032
- Columbia Univeristy Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- At least three years from completion of treatment for Hodgkin's Disease
- Age 18- 35
- Ability to complete self report questionnaires in either English or Spanish
- Willingness of patient, or parent/guardian if patient less than 18 years of age to sign consent to participate in study
- Willingness of patient to sign assent if greater than 7 years of age and less than 18 years
Exclusion Criteria:
- Pregnant or breast feeding
- Tanner Stage 1
- Currently taking cyclosporine, niacin, antiretrovirals, macrolide antibiotic, azole antifungal
- Liver enzymes greater than 1.5 times the upper level of normal
- Creatine Kinase greater than 2 times the upper level of normal
- Use of estrogen containing contraceptive
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:A Intervention Arm
Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma
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All patients will start at 10mg of simvastatin, and then, based on results of interim evaluation escalated to 20mg and then 40.
Patients will stay on maximally tolerated dose of drug until the end of the study at 26 weeks.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
大体时间:Up to 26 weeks
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Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.
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Up to 26 weeks
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Number of Participants Experiencing Grade 3 or Higher Liver Toxicity
大体时间:Up to 26 Weeks
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Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.
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Up to 26 Weeks
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Change in Carotid Intima-media Thickness Test (CIMT)
大体时间:Up to 26 Weeks
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A change in CIMT measurements ( measured in millimeters (mm)) will be performed.
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Up to 26 Weeks
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合作者和调查者
调查人员
- 首席研究员:Jennifer Levine, MD、Columbia Univeristy Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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