- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212965
Selenium in the Treatment of Complicated Lymphatic Malformations
April 22, 2013 updated by: Michael Kelly, Medical College of Wisconsin
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Children's Hospital of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations
Time Frame: pretreatment and at 6 months
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Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.
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pretreatment and at 6 months
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Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations
Time Frame: throughout duration of study
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throughout duration of study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome
Time Frame: throughout duration of study
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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
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throughout duration of study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael E Kelly, MD, PhD, Medical College of Wisconsin
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
September 29, 2010
First Posted (Estimate)
October 1, 2010
Study Record Updates
Last Update Posted (Estimate)
April 23, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/93
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Palvella Therapeutics, Inc.Not yet recruitingMicrocystic Lymphatic MalformationUnited States
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University of ArkansasCompletedLymphatic Malformations | Hemangiomas | Venous Malformations
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Nanjing Children's HospitalRecruiting
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Protara TherapeuticsRecruiting
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Avalo Therapeutics, Inc.WithdrawnLymphatic MalformationUnited States
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Sohag UniversityRecruitingVascular Malformations | Microcystic Lymphatic Malformation | Combined Vascular MalformationEgypt
Clinical Trials on Selenium
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-
Quadram Institute BioscienceFood Standards Agency, United KingdomCompleted
-
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Abbott NutritionCompletedPreterm InfantsUnited States
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University of ArizonaNational Cancer Institute (NCI)CompletedProstate Cancer
-
Vanderbilt UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated
-
University of CalgaryInternational Centre for Diarrhoeal Disease Research, BangladeshCompleted
-
Peking Union Medical College HospitalUnknown
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Neny TrianaCompletedAutism Spectrum DisorderIndonesia
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University of SurreyCompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited Kingdom