Spots Global Cancer Trial Database for Randomized Study of Hormonal Regulation of Infantile Hemangioma

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Trial Identification

Brief Title: Randomized Study of Hormonal Regulation of Infantile Hemangioma

Official Title:

Study ID: NCT00004436

Conditions

Hemangioma

Interventions

leuprolide

prednisone

Study Description

Brief Summary: OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring hemangiomas. II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the safety of GnHRa in these patients.

Detailed Description: PROTOCOL OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to gender and by position of the lesion (periorbital vs nonperiorbital). All patients receive oral prednisone daily for 3 weeks. Patients are then randomized to receive either placebo or leuprolide IM every 3 weeks, while continuing oral prednisone. Tumors are assessed at 1, 3, and 6 weeks. If the tumor is not responding, the leuprolide will be administered every 2 weeks. Tumors are reassessed at 3 and 6 months, at which point the treatment is stopped. Responding patients are observed every 3 weeks for 3 months. If the tumor begins to grow again, leuprolide may be administered for another 3 months. Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy, repeat the leuprolide or prednisone therapy, or undergo surgical excision.