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Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors
This study is currently recruiting participants.
Verified by Columbia University, September 2008
First Received: September 2, 2008   No Changes Posted
Sponsor: Columbia University
Collaborator: Children's Hospital of Philadelphia
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00746603
  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: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ]

Estimated Enrollment: 28
Study Start Date: January 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746603

Contacts
Contact: Jennifer Levine, MD 212-305-2368 jl175@columbia.edu
Contact: JoAnn Benn, FNP 212-305-2355 jt495@columbia.edu

Locations
United States, New York
Columbia Univeristy Medical Center Recruiting
New York, New York, United States, 10032
Contact: Solimar Curumi     212-305-2354     sc2394@columbia.edu    
Principal Investigator: Jennifer Levine            
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 Medical Center ( Jennifer Levine, MD )
Study ID Numbers: AAAB4447
Study First Received: September 2, 2008
Last Updated: September 2, 2008
ClinicalTrials.gov Identifier: NCT00746603     History of Changes
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on February 08, 2010