? Infantile hemangiomas are clonal tumors composed of endothelial-like cells that grow in ? the first months of life. The incidence and severity appears to be increasing, perhaps ? related to the increase in the rate of low birth weight infants in the United States. Most infantile hemangiomas are found in the skin, but sometimes, they occur in other organs in the body such as the liver, spleen, intestine, airway, lungs and the central nervous system. At birth hemangiomas are either absent or barely evident; they grow in the first few weeks to months of life, followed by a longer phase where they tend to get smaller over several months to years. While most are benign in their behavior, large and aggressive hemangiomas may require treatment to control the growth of this tumor. Rapid growth may lead to complications such as permanent disfigurement, ulceration, bleeding, loss of vision, airway obstruction, congestive heart failure and rarely death. There is a lack of uniform guidelines for the treatment and methods to measure response to treatment of infants with hemangiomas. No systematic strategy currently exists to identify toxicities to therapy for infants with hemangiomas. The overall goal of this trial is to determine and compare the effectiveness and safety of oral prednisolone and IV vincristine in the treatment of infants diagnosed with large, complicated hemangiomas. A multi-center randomized trial is proposed with study participation from 3 sites. For this purpose, 50 infants with large and complicated hemangiomas who meet criteria for systemic treatment will be randomly assigned to receive either daily oral prednisolone or weekly IV vincristine. The response to these therapies will be measured with three standardized response criteria. Patients who fail therapy by evidence of progressive disease at week 6 will crossover to the other therapy arm to complete a total of 12 weeks of therapy. The diagnostic, therapeutic and response criteria experimentally determined in this study may be used as a framework for future multi-institutional clinical trials to treat hemangiomas. Uniform guidelines for treatment and methods to measure response to treatment of infants with hemangiomas are lacking. The overall goal of this trial is to objectively determine and compare the effectiveness and safety of oral steroids and IV vincristine in the treatment of infants diagnosed with large, complicated hemangiomas. ? ? ?
