Randomized Study of Hormonal Regulation of Infantile Hemangioma

• Status: Completed
• Trial end date: 2000-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborators: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Leuprolide; Prednisone

Criteria

• Presence of hemangioma meeting at least one of the following criteria:

Vision-threatening because of induced astigmatism or occlusion of the visual axis or proptosis Severe anatomic distortion compromising function of an organ or creating an unacceptable cosmetic outcome Other complications, e.g., Kasabach-Merritt consumptive coagulopathy, high-output heart failure, etc.

• No lesions that are clearly regressing before therapy

• No vascular malformations other than juvenile hemangiomas