Expired Study
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New York, New York 10032


Purpose:

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.


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


Study is Available At:


Original ID:

AAAB4447


NCT ID:

NCT00746603


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Poor enrollment


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jennifer Levine, MD
Principal Investigator
Columbia Univeristy Medical Center

Study Dates

Start Date:January 2008
Completion Date:July 2009
Completion Type:Actual
Primary Completion Date:July 2009
Primary Completion Type:Actual
Verification Date:July 2013
Last Changed Date:July 17, 2013
First Received Date:September 2, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Carotid Artery Intima Media Thickness
Time Frame:26 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Liver Function Tests and Creatine Kinase
Time Frame:every 4 weeks x 3, then at 26 weeks
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Simvastatin
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.
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Escalating dose of simvastatin

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Children's Hospital of Philadelphia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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