Not provided
Not provided
Not provided
Not provided
Not provided
The investigators chose to terminate the study due to participant attrition. Of the limited data evaluable, none of the patients experienced adverse events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium | Drug | 400 μg once a day for 6 months by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations | Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values. | pretreatment and at 6 months |
| Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations | throughout duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome | 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 | throughout duration of study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael E Kelly, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
Not provided
| ID | Term |
|---|---|
| D044148 | Lymphatic Abnormalities |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D012643 | Selenium |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008903 | Minerals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided