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A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease


N/A
18 Years
35 Years
Not Enrolling
Both
Carotid Artery Disease

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Trial Information

A Feasibility Study to Evaluate the Safety of Simvastatin in Young Adults Treated for Hodgkin's Disease


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Liver Function Tests and Creatine Kinase

Outcome Time Frame:

every 4 weeks x 3, then at 26 weeks

Safety Issue:

Yes

Principal Investigator

Jennifer Levine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia Univeristy Medical Center

Authority:

United States: Institutional Review Board

Study ID:

AAAB4447

NCT ID:

NCT00746603

Start Date:

January 2008

Completion Date:

July 2009

Related Keywords:

  • Carotid Artery Disease
  • Carotid Artery Diseases
  • Hodgkin Disease

Name

Location

Columbia Univeristy Medical CenterNew York, New York  10032