Clinical Trial: Selenium in the Treatment of Complicated Lymphatic Malformations

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary:

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.

Hypotheses:

  • 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.

Detailed Summary:
Sponsor: Medical College of Wisconsin

Current Primary Outcome:

  • Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations [ Time Frame: pretreatment and at 6 months ]
    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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome [ Time Frame: throughout duration of study ]

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


Original Secondary Outcome: Same as current

Information By: Medical College of Wisconsin

Dates:
Date Received: September 24, 2010
Date Started: September 2010
Date Completion:
Last Updated: April 22, 2013
Last Verified: April 2013