| November 7, 2007 |
| January 15, 2009 |
| November 2007 |
| December 2010 (final data collection date for primary outcome measure) |
| Decrease in size of hemangioma by MRI and clinical exam [ Time Frame: Initial visit, 6 weeks, 12 weeks ] |
| Same as current |
| Complete list of historical versions of study NCT00555464 on ClinicalTrials.gov Archive Site |
| Toxicity to medications [ Time Frame: Initial visit, 2, 4, 6, 10 and 12 weeks of therapy ] |
| Same as current |
| |
| Clinical Trial of Vincristine vs. Prednisolone for Treatment of Complicated Hemangiomas |
| A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile |
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. |
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. |
| Phase II |
| Interventional |
| Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
| Hemangioma |
- Drug: Vincristine
- Drug: Prednisone
|
- Experimental: Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.
- Active Comparator: The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.
|
| |
| |
| Recruiting |
| 50 |
| January 2011 |
| December 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
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.
|
| Both |
| up to 6 Months |
| No |
|
|
| United States |
| |
| NCT00555464 |
| Beth A. Drolet, MD & Michael E. Kelly, MD, Ph.D., Medical College of Wisconsin |
| 3429, #FDA-R-003429-01 |
| FDA Office of Orphan Products Development |
- Medical College of Wisconsin
- University of California, San Francisco
- Indiana University
|
| Principal Investigator: |
Beth Drolet, MD |
Medical College of Wisconsin |
|
| Principal Investigator: |
Michael Kelly, MD, PhD |
Medical College of Wisconsin |
|
|
| FDA Office of Orphan Products Development |
| January 2009 |