Selenium in the Treatment of Complicated Lymphatic Malformations
This study has been terminated.
(The investigators chose to terminate the study due to participant attrition. Of the limited data evaluable, none of the patients experienced adverse events.)
Information provided by (Responsible Party):
Michael Kelly, Medical College of Wisconsin
First received: September 24, 2010
Last updated: April 22, 2013
Last verified: April 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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||14 Years to 30 Years (Child, Adult)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01212965
|Children's Hospital of Wisconsin
|Milwaukee, Wisconsin, United States, 53226 |
Medical College of Wisconsin
||Michael E Kelly, MD, PhD
||Medical College of Wisconsin
||Michael Kelly, Principal Investigator, Medical College of Wisconsin
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2010
||April 22, 2013
Keywords provided by Medical College of Wisconsin:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2017
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs