Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

NCT ID: NCT00746603

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-07-31

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

Conditions

Carotid Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A Intervention Arm

Escalating dose of simvastatin in subjects who are survivors of Hodgkin Lymphoma

Group Type: EXPERIMENTAL

Simvastatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Zocor

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia Univeristy Medical Center

Locations

Columbia Univeristy Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAB4447

Identifier Type: -

Identifier Source: org_study_id