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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Children's Hospital Boston |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004436 |
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 |
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Hemangioma |
Drug: leuprolide Drug: prednisone |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Placebo Control, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | July 1993 |
Estimated Study Completion Date: | June 2000 |
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.
Ages Eligible for Study: | 1 Month to 8 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Study ID Numbers: | 199/13399, CH-B-FDR000967 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004436 |
Health Authority: | United States: Federal Government |
cardiovascular and respiratory diseases hemangioma rare disease |
Prednisone Leuprolide Hemangioma, Capillary |
Respiration Disorders Rare Diseases Hemangioma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Glucocorticoids |
Hormones Pharmacologic Actions Neoplasms Therapeutic Uses Fertility Agents, Female Fertility Agents Neoplasms, Vascular Tissue |