Status:
TERMINATED
Selenium in the Treatment of Complicated Lymphatic Malformations
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Lymphatic Malformations
Eligibility:
All Genders
14-30 years
Phase:
PHASE1
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. Inform...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01212965
Start Date
September 1 2010
End Date
November 1 2012
Last Update
April 23 2013
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226