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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
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemangioma focused on measuring cardiovascular and respiratory diseases, hemangioma, rare disease

Eligibility Criteria

1 Month - 8 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    Boston Children's Hospital
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    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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