Feasibility Study of Simvastatin in Hodgkin's Lymphoma Survivors

NCT00746603 | Terminated Results DMC

• 1 other identifier: AAAB4447
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Disease

Outcome Measures

Primary Outcomes (3)

• Number of Participants Experiencing Grade 3 or Greater Muscle Toxicity

  Number of participants experiencing grade 3 or greater muscle toxicity as evaluated by creatinine kinase laboratory tests.

  Up to 26 weeks

• Number of Participants Experiencing Grade 3 or Higher Liver Toxicity

  Number of participants experiencing grade 3 or higher liver toxicity as determined by liver function laboratory tests.

  Up to 26 Weeks

• Change in Carotid Intima-media Thickness Test (CIMT)

  A change in CIMT measurements ( measured in millimeters (mm)) will be performed.

  Up to 26 Weeks

Study Arms (1)

A Intervention Arm

EXPERIMENTAL

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

Drug: Simvastatin

Interventions

Simvastatin 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.

Also known as: Zocor

A Intervention Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Columbia Univeristy Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Early termination due to poor accrual

Results Point of Contact

• Title: Jennifer Levine, MD
• Organization: Weill Cornell Medicine

jel9022@med.cornell.edu

212-305-9770

Study Officials

• Jennifer Levine, MD

  Columbia Univeristy Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2021-02

Locations

US (1)