Weekly treatment with sirolimus for venous and lymphatic malformations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of administering sirolimus once a week for patients with venous and lymphatic malformations. The study aims to assess not only the therapeutic benefits of this dosing schedule but also patient satisfaction and any adverse effects experienced during the treatment. Participants will receive the medication for a duration of six months, with the possibility of continuing treatment afterward. The trial seeks to provide a safer alternative to daily dosing, which is associated with significant side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Chelsea Shope, MSCR — Medical University of South Carolina
• Study coordinator: Stephnie Munie, BS
• Email: munie@musc.edu
• Phone: 843-566-2453

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.