Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
Primary Purpose
Carotid Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simvastatin
Sponsored by
About this trial
This is an interventional other trial for Carotid Artery Disease
Eligibility Criteria
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
Sites / Locations
- Columbia Univeristy Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A Intervention Arm
Arm Description
Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma
Outcomes
Primary Outcome Measures
Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.
Number of Participants Experiencing Grade 3 or Higher Liver Toxicity
Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.
Change in Carotid Intima-media Thickness Test (CIMT)
A change in CIMT measurements ( measured in millimeters (mm)) will be performed.
Secondary Outcome Measures
Full Information
NCT ID
NCT00746603
First Posted
September 2, 2008
Last Updated
February 10, 2021
Sponsor
Columbia University
Collaborators
Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT00746603
Brief Title
Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
Official Title
A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University
Collaborators
Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A Intervention Arm
Arm Type
Experimental
Arm Description
Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity
Description
Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.
Time Frame
Up to 26 weeks
Title
Number of Participants Experiencing Grade 3 or Higher Liver Toxicity
Description
Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.
Time Frame
Up to 26 Weeks
Title
Change in Carotid Intima-media Thickness Test (CIMT)
Description
A change in CIMT measurements ( measured in millimeters (mm)) will be performed.
Time Frame
Up to 26 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Levine, MD
Organizational Affiliation
Columbia Univeristy Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univeristy Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
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