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Randomized Study of Hormonal Regulation of Infantile Hemangioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004436
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston Children’s Hospital
Information provided by:
FDA Office of Orphan Products Development
  Purpose

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 Intervention
Hemangioma Drug: leuprolide Drug: prednisone

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 30
Study Start Date: July 1993
Estimated Study Completion Date: June 2000
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 8 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
FDA Office of Orphan Products Development
Boston Children’s Hospital
Investigators
Study Chair: Lois Hodgson Smith Boston Children’s Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00004436     History of Changes
Other Study ID Numbers: 199/13399
CH-B-FDR000967
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
Last Verified: August 2000

Keywords provided by FDA Office of Orphan Products Development:
cardiovascular and respiratory diseases
hemangioma
rare disease

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Prednisone
Leuprolide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents