RECRUITING

Weekly Sirolimus Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In current practice, options for venous and lymphatic malformations remain limited. Recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. Unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. The purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. Additionally, the study will evaluate patient satisfaction and identify adverse effects. Participants will be on the medication for 6 months with an option to continue after this time period.

Official Title

Weekly Sirolimus Therapy for the Treatment of Venous and Lymphatic Malformations

Quick Facts

Study Start:2022-01-18
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04861064

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.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient 2 years of age and older
  2. * Venous, lymphatic, or venolymphatic malformations
  1. * Children with contraindication to use of sirolimus
  2. * Children with history of transplant
  3. * Children with a history of natural immunodeficiency
  4. * Children with a history of artificially induced immunodeficiency
  5. * Children with a history of a serious or life-threatening infection
  6. * Children taking CYP3A4 inhibiting medications
  7. * Children taking strong CYP3A4 inducers to avoid subtherapeutic dosing/exposure.
  8. * Inability or unwillingness of subject or legal guardian/representative to give informed consent
  9. * 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.

Contacts and Locations

Study Contact

Stephnie Munie, BS
CONTACT
843-566-2453
munie@musc.edu

Principal Investigator

Chelsea Shope, MSCR
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina
Charleston, South Carolina, 29403
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

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

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 Registration Dates

Study Start Date2022-01-18
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-01-18
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Venous Malformation
  • Lymphatic Malformation