Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease|
- Liver Function Tests and Creatine Kinase [ Time Frame: every 4 weeks x 3, then at 26 weeks ] [ Designated as safety issue: Yes ]
- Carotid Artery Intima Media Thickness [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Escalating dose of simvastatin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746603
|United States, New York|
|Columbia Univeristy Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Jennifer Levine, MD||Columbia Univeristy Medical Center|