- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004436
Randomized Study of Hormonal Regulation of Infantile Hemangioma
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.
Study Overview
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.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Lois Hodgson Smith, Boston Children's Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Vascular Tissue
- Hemangioma
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Reproductive Control Agents
- Fertility Agents, Female
- Fertility Agents
- Leuprolide
- Prednisone
Other Study ID Numbers
- 199/13399
- CH-B-FDR000967
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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