Actively Recruiting
Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2023-02-24
250
Participants Needed
3
Research Sites
740 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The phosphatidylinositol 3-kinase (PI3Kinase)/Protein Kinase B (AKT)/mammalian target of rapamycin (mTor) pathway plays a role on the development and the venous/lymphatic vascular organisations. The investigators want to study the efficacy and the safety of Rapamycin, an mTor inhibitor.
CONDITIONS
Official Title
Efficacy and Safety of Sirolimus in Vascular Anomalies That Are Refractory to Standard Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with complex vascular anomalies refractory to standard care such as medical treatment, surgery, or sclerotherapy/embolization
- Adequate medullary function: hemoglobin > 10.0 g/dl, neutrophils > 1500/mm³, and platelets > 100,000/mm³
- Laboratory values: total serum bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN total bilirubin with direct bilirubin ≤ 1.5 x ULN for Gilbert Syndrome)
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or < 5.0 x ULN if hepatic metastases present)
- Serum creatinine ≤ 1.5 x ULN or a 24-hour creatinine clearance ≥ 60 mL/min if serum creatinine is ≥ 1.5 x ULN
- Karnofsky performance status > 50
- Ability to sign informed consent
- Women of childbearing age must agree to use contraceptive methods during the study
You will not qualify if you...
- Severe or uncontrolled medical conditions that may affect participation or study results, including significant cardiac diseases or recent myocardial infarction within 6 months
- Gastrointestinal diseases impairing absorption of sirolimus (e.g., ulcerative diseases, uncontrolled nausea/vomiting, diarrhea ≥ Grade 2, malabsorption, small bowel resection)
- Known hypersensitivity to drugs similar to study treatment
- Other severe or uncontrolled medical conditions contraindicating study participation (e.g., pancreatitis, liver cirrhosis, active chronic hepatitis, severely impaired lung function with spirometry ≤ 50% predicted or O2 saturation ≤ 88% at rest)
- Immunocompromised patients, including known HIV seropositivity
- Pregnant or lactating women
- Prior treatment with PI3K and/or mTOR inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Cliniques Universitaires Saint-Luc, Université Catholique de Louvain Bruxelles
Brussels, Brussels Capital, Belgium, 1200
Actively Recruiting
2
CHU Caen
Caen, Brittany Region, France, 14000
Actively Recruiting
3
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
Research Team
L
Laurence M. Boon, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here