Selenium in the Treatment of Complicated Lymphatic Malformations

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01212965
• Date of registration: 24/09/2010
• Prospective Registration: No
• Primary sponsor: Medical College of Wisconsin
• Public title: Selenium in the Treatment of Complicated Lymphatic Malformations
• Scientific title: Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults
• Date of first enrolment: September 2010
• Target sample size: 5
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01212965
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Michael E Kelly, MD, PhD
• Affiliation: Medical College of Wisconsin

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have clinical and radiographic features consistent with a lymphatic
malformation (LM). Patients with combined venous lymphatic malformations (CVLM) will
be included if the predominant componet is lymphatic based on MRI. Both macrocystic
and microcystic LM will be eligible. Tissue biopsy is required to confirm the
presence of an abnormal lymphatic malformation.

- All patients diagnosed with lymphatic malformations between 14 and 30 years of age
will be eligible.

- Patients must have lymphatic malformations with potential to cause morbidity
including one or more of the following: Lymphedema, Coagulopathy, Chronic Pain,
Recurrent Cellulitis (> 1 episodes/year), Ulceration and/or bleeding, Impairment of
organ function, Visceral and/or bone involvement, or Disfigurement.

- Patients receiving previous systemic therapy, surgical, debulking, or sclerotherapy
will be eligible eight weeks following completion of therapy if they meet all
inclusion criteria.

- All patients and/or their parents or legal guardians must sign a written informed
consent. All institutional FDA requirements for human studies must be met.

Exclusion Criteria:

- Younger than 14 years of age or older than 30 years of age

- Life-threatening complications related to LM

- Patients with preexisting renal, hepatic, or thyroid disorders

- Patients receiving a daily multivitamin supplement or other natural products that
include selenium

- Patients that have received previous selenium therapy will not be eligible

- Women who are pregnant or breastfeeding



Age minimum: 14 Years
Age maximum: 30 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphatic Malformations

Intervention(s)

Drug: Selenium

Primary Outcome(s)

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

Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations [Time Frame: throughout duration of study]

Secondary Outcome(s)

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

Secondary ID(s)

10/93

Source(s) of Monetary Support

Please refer to primary and secondary sponsors