Selenium in the Treatment of Complicated Lymphatic Malformations
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies, Endocrine |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 14 - 30 |
| Updated: | 3/30/2013 |
| Start Date: | September 2010 |
| Contact: | Jessica L Arndt, BA |
| Email: | jarndt@mcw.edu |
| Phone: | 414-266-1599 |
Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults
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.
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
We found this trial at
1
site
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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