Randomized Study of Hormonal Regulation of Infantile Hemangioma
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|ClinicalTrials.gov Identifier: NCT00004436|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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 or disease||Intervention/treatment||Phase|
|Hemangioma||Drug: leuprolide Drug: prednisone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Study Start Date :||July 1993|
|Study Completion Date :||June 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004436
|Study Chair:||Lois Hodgson Smith||Boston Children’s Hospital|