Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Sirolimus administration: Sirolimus will be given at a dose of 0.8 mg/m² twice daily to each patient. Maximum dose is set as 5 mg/dose. The first dose of the drug will be supervised by
Sponsors
Dr Saurav Sharma(self)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged =18 years diagnosed with Newly diagnosed vascular malformation. 2.Patients with benign vascular tumors who are refractory to 3 months of conventional therapy. 3.Patients with locally aggressive vascular tumors 4.Written informed consent
Exclusion criteria
Exclusion criteria: 1.Children less than 1 year of age with infantile hemangioma. 2.Known hypersensitivity to sirolimus 3.Concurrent nephrotoxic agent use 4.CYP3A4 inducers or inhibitors while receiving sirolimus 5.Baseline cytopenias (ANC less than 500/mm3, Hb less than 8 gm/dl, and platelet less than 50,000/mm3). 6.Baseline SGOT/SGPT more than 5 times ULN or serum bilirubin more than 1.5 times ULN 7.Abnormal lipid profiles: triglycerides (TG) more than 130mg/dl, cholesterol more than 170 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in size of vascular anomalyTimepoint: 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of types of vascular anomaly.Timepoint: at the end of study.;Evaluation of side effect of the Sirolimus during the treatment.Timepoint: 3 month;Improvement in clinical signs and symptoms of vascular mnalformation.Timepoint: 3 month;Improvement in quality of life of the patients.Timepoint: 3 month | — |
Countries
India
Contacts
Public ContactDr Jagdish Prasad Meena
AIIMS, New Delhi
Outcome results
None listed