Safety and Efficacy Study of Sirolimus in Complicated Vascular Anomalies

Inclusion criteria

• ✓. Patients who have undergone surgical resection or interventional radiology procedures for disease control are eligible if they meet all inclusion criteria after surgery/procedure
• ✓. Surgery: At least 2 weeks since undergoing any major surgery
• ✓. Steroids: Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Other patients, such as vascular tumor patients, need to be on a weaning dose of steroids (steroid use defined as intravenous or oral steroids required for more than one day).
• ✓. Myelosuppressive chemotherapy: Must not have received within 4 weeks of entry onto this study.
• ✓. Hematopoietic GFs: At least 7 days since the completion of therapy with a GF that supports platelet, red or white cell number or function.
• ✓. Biologic (anti-neoplastic agent): At least 14 days since the completion of therapy with a biologic agent. For agents that have known AEs occurring beyond 14 days after administration, this period must be extended beyond the time during which AEs are known to occur. These patients must be discussed with the Study Chair on a case-by-case basis.
• ✓. Patients diagnosed with Kaposiform Hemangioendotheliomas or Tufted Angiomas will not require a washout period prior to enrollment, but will be required to discontinue the use of prohibited concomitant medications upon enrollment in the study following the guidelines of the protocol.
• ✓. Investigational Drugs: Patients must not have received any non-FDA approved drug within 4 weeks.