Selenium in the Treatment of Complicated Lymphatic Malformations
|ClinicalTrials.gov Identifier: NCT01212965|
Recruitment Status : Terminated (The investigators chose to terminate the study due to participant attrition. Of the limited data evaluable, none of the patients experienced adverse events.)
First Posted : October 1, 2010
Last Update Posted : April 23, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Malformations||Drug: Selenium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||November 2012|
- Drug: Selenium
400 μg once a day for 6 months by mouthOther Name: Selenase
- 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 ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|