Randomized Study of Hormonal Regulation of Infantile Hemangioma
Primary Purpose
Hemangioma
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
leuprolide
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Hemangioma focused on measuring cardiovascular and respiratory diseases, hemangioma, rare disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004436
First Posted
October 18, 1999
Last Updated
March 24, 2015
Sponsor
FDA Office of Orphan Products Development
Collaborators
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00004436
Brief Title
Randomized Study of Hormonal Regulation of Infantile Hemangioma
Study Type
Interventional
2. Study Status
Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
July 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
FDA Office of Orphan Products Development
Collaborators
Boston Children's Hospital
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemangioma
Keywords
cardiovascular and respiratory diseases, hemangioma, rare disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
leuprolide
Intervention Type
Drug
Intervention Name(s)
prednisone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
8 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois Hodgson Smith
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Randomized Study of Hormonal Regulation of Infantile Hemangioma
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