Selenium in the Treatment of Complicated Lymphatic Malformations

Medical College of Wisconsin

Status and phase

Terminated

Phase 1

Conditions

Lymphatic Malformations

Treatments

Drug: Selenium

Study type

Interventional

Funder types

Other

Identifiers

NCT01212965

10/93

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

14 to 30 years old

Volunteers

No Healthy Volunteers

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