NCT01212965终止1 期
Pilot Clinical Trial to Estimate the Safety and Efficacy of Selenium in the Treatment of Complicated Lymphatic Malformations in Adolescents and Young Adults
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Determine a preliminary rate to oral selenium in adolescents and young adults with symptomatic lymphatic malformations
时间窗: pretreatment and at 6 months
Disease will be assessed by volumetric MRI and patient quality of life assessments at 6 months of therapy and compared to pretreatment values.
Determine the safety of oral selenium in adolescents and young adults with symptomatic lymphatic malformations
时间窗: throughout duration of study
次要结局
- Correlate selenium drug levels, expression of selenoproteins and IL-20with outcome(throughout duration of study)
研究者
Michael Kelly
Principal Investigator
Medical College of Wisconsin
研究点 (2)
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