Selenium in the Treatment of Complicated Lymphatic Malformations
The investigators propose a pilot trial to obtain preliminary information regarding the safety and response rate of patients with symptomatic lymphatic malformations treated with oral Selenium. Information obtained in this pilot trial will be used to plan future phase 2 clinical trials.
- Selenium will be safe and efficacious in the treatment of adolescents and young adults with symptomatic lymphatic malformations
- Disease response will correlate with serum levels of selenium and blood levels of antioxidants essential to selenium metabolism.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults|
- Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations [ Time Frame: pretreatment and at 6 months ] [ Designated as safety issue: No ]Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.
- Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations [ Time Frame: throughout duration of study ] [ Designated as safety issue: Yes ]
- Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome [ Time Frame: throughout duration of study ] [ Designated as safety issue: No ]Whole blood will be drawn prior to therapy and at specific time intervals after initiating selenium. Serum concentrations of selenium, selenium-dependent tripeptide glutathione and IL-20 will be measured and correlated with outcome
|Study Start Date:||September 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212965
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Michael E Kelly, MD, PhD||Medical College of Wisconsin|