NCT00004436

Randomized Study of Hormonal Regulation of Infantile Hemangioma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 1 Month – 8 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Hemangioma

Interventions

Type	Name	Description
DRUG	leuprolide
DRUG	prednisone

Timeline

• Start date: 1993-07-01
• Completion: 2000-06-01
• First posted: 1999-10-19
• Last updated: 2015-03-25