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.

Condition	Treatment or Intervention
Hemangioma	Drug: leuprolide  Drug: prednisone

Further Study Details: 

Expected Total Enrollment:  30

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.

Ages Eligible for Study:  1 Month   -   8 Months,  Genders Eligible for Study:  Both

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

Study chairs or principal investigators

Lois Hodgson Smith,  Study Chair,  Children's Hospital Boston   

Study ID Numbers:  199/13399; CH-B-FDR000967
Record last reviewed:  August 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004436
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08