Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

This study has been terminated.
(Poor enrollment)
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00746603
First received: September 2, 2008
Last updated: July 17, 2013
Last verified: July 2013
  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.


Condition Intervention
Carotid Artery Disease
Drug: Simvastatin

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Liver Function Tests and Creatine Kinase [ Time Frame: every 4 weeks x 3, then at 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Carotid Artery Intima Media Thickness [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Escalating dose of simvastatin
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746603

Locations
United States, New York
Columbia Univeristy Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jennifer Levine, MD Columbia Univeristy Medical Center
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00746603     History of Changes
Other Study ID Numbers: AAAB4447
Study First Received: September 2, 2008
Last Updated: July 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014