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Weekly Sirolimus for Venous and Lymphatic Malformations

This study is testing if taking the medication sirolimus once a week can help treat venous malformations (abnormal veins) and lymphatic malformations (abnormal lymph vessels). Sirolimus is currently used for these conditions, but usually taken more often, which can cause side effects. This study aims to see if a weekly dose is effective and has fewer side effects. You may be able to join if you are at least 2 years old and have a venous, lymphatic, or venolymphatic malformation. Researchers will measure changes in the size of your malformation over 6 months to see if the treatment is working. The current status of this study is unclear, but it plans to enroll 24 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.
What's involved
Participants will take sirolimus once a week for 6 months. The size of your malformation will be measured at the beginning and end of this 6-month period.
Compensation
Not stated in the trial record.
Follow-up
The study measures changes in your malformation at 6 months, and you may have the option to continue treatment after this time.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04861064

Weekly Sirolimus Therapy

Recruiting
PHASE2Ages 2+InterventionalTreatment
Medical University of South Carolina
~24 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Sirolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in size of lesion
Measured over Baseline and 6 months
+1 more outcome measured

Conditions

Venous Malformation
Lymphatic Malformation

Explore related trials

Lymphatic malformationVenous-lymphatic malformationVenous Malformation

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Chelsea Shope, MSCR · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Stephnie Munie, BS
[email protected]
843-566-2453
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient 2 years of age and older
Venous, lymphatic, or venolymphatic malformations

Exclusion

Children with contraindication to use of sirolimus
Children with history of transplant
Children with a history of natural immunodeficiency
Children with a history of artificially induced immunodeficiency
Children with a history of a serious or life-threatening infection
Children taking CYP3A4 inhibiting medications
Children taking strong CYP3A4 inducers to avoid subtherapeutic dosing/exposure.
Inability or unwillingness of subject or legal guardian/representative to give informed consent
Women that are or may become pregnant o Sirolimus is a Pregnancy Category C drug. No randomized controlled studies have been done on pregnant women. Women of childbearing potential must be on effective contraception prior to, during, and for 12 weeks following sirolimus therapy.

What this trial measures

  • Change in size of lesionBaseline and 6 months

    Will be measuring the size of the lesions (mm) at each patient visit

  • Change in size of lesion through photographBaseline and 6 months

    Will be evaluating clinical photographs of lesions at each patient visit