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Disclaimer

This information does not represent SPD endorsement of any posted study. The SPD has no jurisdiction over or involvement directly with these studies. All studies listed have been approved by the Institutional Review Board.

If you are presently under the care of a physician for a skin condition, you should not disrupt your current treatment program before discussing it with your doctor(s).

A Phase II Randomized Clinical Trial Assessing the Efficacy and Safety of Oral Prednisolone vs. Intravenous Vincristine in the Treatment of Infantile Hemangiomas

Posted August 19, 2008

Description of Study:

Infants with large hemangiomas are often treated systemically with oral steroids (Prednisolone) to prevent complications. The best treatment for hemangiomas is not known. Also, the best method to measure the response of hemangiomas to treatment is not known. The goals of this study are to determine whether Prednisolone or Vincristine is more effective and safer for treating infants with hemangiomas and to determine if changes on MRI scan are more sensitive than changes on clinical exam for detecting responses to treatment. A total of 50 babies younger than 6 months old with hemangiomas requiring treatment will take part in this study. Participating hospitals include Children's Hospital of Wisconsin, Riley Hospital for Children in Indianapolis, and the University of California, San Francisco Children's Hospital. We anticipate 20 patients from Children's Hospital of Wisconsin will participate during three years.

Skin Condition:

Infantile hemangioma

Inclusion Criteria:

Infants age 0-6 months old.
Infants must have clear indications for treatment including one of the following complications: ulceration (skin breakdown), impairment of vision, impairment of hearing, obstruction of the airway (windpipe), heart failure (heart does not pump properly), bleeding, abdominal distention (bloating, fullness), compartment syndrome (swelling due to reduced blood flow in and out of an area of the body due to the presence of the hemangioma), pressure on the spinal cord, or high risk of permanent disfigurement.
Hemangiomas must be large (greater than or equal to 50 cm2)

Reasons Why You May Not Qualify:

Children greater than 6 months old.
Hemangiomas that are too small (less than 50 cm2)
Hemangioma involving the central nervous system (brain and/or spinal cord)
Infants who have received prior therapy with corticosteroids (oral or in a vein), interferon or vincristine are not eligible for enrollment.

Study Specifics:

Enrolled patients will be randomly assigned to receive either daily Prednisolone by mouth or weekly Vincristine in a vein for 12 weeks. Response to treatment will be monitored by clinical exams every two weeks and by an MRI at study entry and six and 12 weeks later. Patients with evidence of progressive disease (larger hemangioma and/or increased functional impairment) at week six will be switched to the other drug to complete a total of 12 weeks of medication therapy. Side effects of each medication will be monitored closely determined from histories, physical exams, blood tests and other studies as necessary. Participation in this study will last two years: 12 weeks of treatment and follow-up visits every two-three months for two years. Patients are not compensated for participation; however, if considerable travel is required to take part, arrangements can be made for some reimbursement.

IRB Approved

Financial Sponsor:
US Food and Drug Administration and Greater Milwaukee Foundation

Institutions:
Medical College of Wisconsin/Children's Hospital of Wisconsin
Indiana University/Riley Hospital for Children
University of California, San Francisco Children's Hospital

Study duration:
Patient enrollment: January 2008 – January 2011

If you are interested in being involved in this research study or interested in receiving more information, please contact:

Beth Drolet or Michael Kelly (Primary Investigators)

Or Amy Heinrich (Nursing Coordinator)

Phone: (414) 456-5769

Or E-mail: aheinric@mcw.edu

Location of Study and Hours of Contact: Medical College of Wisconsin/Children's Hospital of Wisconsin (primary site); hours: 0800-1630 (central time)

Clinical Research