- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00746603
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.
Study Overview
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10032
- Columbia Univeristy Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A Intervention Arm
Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
Time Frame: Up to 26 weeks
|
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
Time Frame: Up to 26 Weeks
|
Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.
|
Up to 26 Weeks
|
Change in Carotid Intima-media Thickness Test (CIMT)
Time Frame: Up to 26 Weeks
|
A change in CIMT measurements ( measured in millimeters (mm)) will be performed.
|
Up to 26 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer Levine, MD, Columbia Univeristy Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Carotid Artery Diseases
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- AAAB4447
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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