Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
Information source: Columbia University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Carotid Artery Disease
Intervention: Simvastatin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Columbia University Official(s) and/or principal investigator(s):
Jennifer Levine, MD, Principal Investigator, Affiliation: Columbia Univeristy Medical Center
Overall contact:
Jennifer Levine, MD, Phone: 212-305-2368, Email: jl175@columbia.edu
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.
Clinical Details
Official title: A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease
Study design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Liver Function Tests and Creatine Kinase
Secondary outcome: Carotid Artery Intima Media Thickness
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Both.
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
Locations and Contacts
Jennifer Levine, MD, Phone: 212-305-2368, Email: jl175@columbia.edu
Columbia Univeristy Medical Center, New York, New York 10032, United States; Recruiting
Solimar Curumi, Phone: 212-305-2354, Email: sc2394@columbia.edu
Jennifer Levine, Principal Investigator
Additional Information
Starting date: January 2008
Ending date: July 2010
Last updated: September 2, 2008
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