Randomized Study of Hormonal Regulation of Infantile Hemangioma - Full Text View

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Children's Hospital Boston
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004436

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 Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks

Drug Information available for: Prednisone Leuprolide Leuprolide acetate

U.S. FDA Resources

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

Ages Eligible for Study:	1 Month to 8 Months
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004436

Sponsors and Collaborators

FDA Office of Orphan Products Development

Children's Hospital Boston

Investigators

Study Chair:

Lois Hodgson Smith

Children's Hospital Boston

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004436 History of Changes
Other Study ID Numbers:	199/13399, CH-B-FDR000967
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cardiovascular and respiratory diseases
hemangioma
rare disease

Additional relevant MeSH terms:

Hemangioma
Hemangioma, Capillary
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Prednisone
Leuprolide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012