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Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas

This study is currently recruiting participants.
Study NCT00555464.   Last updated on July 1, 2008.   Information provided by FDA Office of Orphan Products Development

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Descriptive Information Fields
Brief Title  Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas
Official Title  A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile
Brief Summary

The goal of this study is to determine the safety and efficacy of Prednisolone and Vincristine for treatment of large, complicated infantile hemangiomas. The diagnostic, therapeutic and response criteria experimentally determined in this study will be used as a framework for future infantile hemangioma studies.

Detailed Description

Infants with large hemangiomas are often treated systemically with oral steroids (Prednisolone) to prevent complications. The best treatment for hemangiomas is not known and there are no medications approved by the FDA for treatment of hemangiomas. Also, the best method to measure the response of hemangioma to treatment is not known. Patients enrolling on this study will be randomly assigned to receive either daily Prednisolone by mouth or weekly Vincristine in a vein. Response to treatment will be monitored by clinical exams every two weeks and by an MRI at study entry and six and twelve weeks later. Patients with evidence of progressive disease (larger hemangiomas) on the week 6 MRI will be switched to the other drug to complete a total of 12 weeks of 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 up to 12 weeks and follow up for protocol.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study
Primary Outcome Measure  Decrease in size of hemangioma by MRI and clinical exam [ Time Frame: Initial visit, 6 weeks, 12 weeks ]
Secondary Outcome Measure  Toxicity to medications [ Time Frame: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy ]
Condition  Hemangioma
Intervention  Drug: Vincristine
Drug: Prednisone
MEDLINE PMIDs
Links Children's Hospital of Wisconsin website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  50
Start Date  November 2007
Completion Date January 2011
Eligibility Criteria 

Inclusion Criteria:

  • Children age 0-6 months old.
  • Infants with infantile hemangiomas with complications that require systemic therapy to control their growth. To be eligible for enrollment infants must have clear indications for systemic treatment.
  • Clinical diagnosis of infantile hemangioma confirmed by tissue biopsy positive for GLUT-1 Immunohistochemical staining. If the risk of bleeding or permanent disfigurement from biopsy is believed to be too great then clinical and radiological characteristics may be used to establish the diagnosis after discussion with the study PI. Patients with GLUT-1 negative vascular tumors such as Kaposiform hemangioendothelioma, tufted angioma, and angiosarcoma are not eligible.
  • Hemangiomas must be greater than or equal to 50 cm2 clinically measured by taking the product of the two largest perpendicular diameters and have one of the following complications: ulceration, impairment of vision, impairment of hearing, obstruction of the airway, high output cardiac failure, bleeding, abdominal distention and/or compartment syndrome, compression of the spinal cord, or high risk of permanent disfigurement.
  • Adequate liver function defined as:

    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and
    • SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.
  • Patients who have received topical or intralesional corticosteroids are eligible to be enrolled. A washout of one week is required prior to study enrollment. Patients who have undergone surgical resection are eligible if they meet all inclusion criteria after surgery.
  • All patients' parents or legal guardians must sign a written informed consent. All institutional and FDA requirements for human studies must be met.

Exclusion Criteria:

  • Children greater then 6 months old.
  • Contraindications to Vincristine: previously diagnosed neuropathy including sensory neuropathy type 1, Charcot- Marie-Tooth or childhood poliomyelitis.
  • Hemangioma involving the central nervous system as Vincristine has poor CNS penetration.
  • Infants who have received prior systemic therapy with corticosteroids (oral or intravenous), interferon or Vincristine are not eligible for enrollment.
  • Patients receiving Vincristine who concomitantly require oral steroids for treatment of non-hemangioma indications such as asthma or atopic dermatitis will be removed from study.
  • A life-threatening intercurrent infection.
  • Infants with an underlying illness that would require use of general anesthesia (as opposed to sedation) for the MRI.
Gender Both
Ages up to 6 Months
Accepts Healthy Volunteers No
Contacts ††
Contact: Beth Drolet, MD     414-266-1569     bdrolet@mcw.edu    
Contact: Michael E. Kelly, MD, PhD     414-456-4170     mekelly@mcw.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00555464
Organization ID 3429
Secondary IDs †† #FDA-R-003429-01
Study Sponsor  FDA Office of Orphan Products Development
Collaborators †† Medical College of Wisconsin
University of California, San Francisco
Indiana University
Investigators 
Principal Investigator:     Beth Drolet, MD     Medical College of Wisconsin    
Principal Investigator:     Michael Kelly, MD, PhD     Medical College of Wisconsin    
Information Provided By FDA Office of Orphan Products Development
Verification Date November 2007
First Received Date  November 7, 2007
Last Updated Date July 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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