Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
FDA Office of Orphan Products Development Medical College of Wisconsin University of California, San Francisco Indiana University |
---|---|
Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00555464 |
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.
Condition | Intervention | Phase |
---|---|---|
Hemangioma |
Drug: Vincristine Drug: Prednisone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Randomized, Clinical Trial Assessing Efficacy And Safety Of Oral Prednisolone vs Intravenous Vincristine In The Treatment Of Infantile |
Estimated Enrollment: | 50 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | January 2011 |
Arms | Assigned Interventions |
---|---|
1: 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.
|
Drug: Vincristine
Vincristine (0.5 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI.
|
2: 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.
|
Drug: Prednisone
Prednisolone given at 3 mg/kg/day by mouth for 12 week
|
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.
Ages Eligible for Study: | up to 6 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate liver function defined as:
Exclusion Criteria:
Contact: Beth Drolet, MD | 414-266-1569 | bdrolet@mcw.edu |
Contact: Michael E. Kelly, MD, PhD | 414-456-4170 | mekelly@mcw.edu |
United States, California | |
University of California, San Francisco | Not yet recruiting |
San Francisco, California, United States, 94143 | |
Principal Investigator: Ilona Frieden, MD | |
United States, Indiana | |
Indiana University/Riley Children's Hospital | Not yet recruiting |
Indianapolis, Indiana, United States, 46202 | |
Principal Investigator: Anita Haggstrom, MD | |
United States, Wisconsin | |
Medical College of Wisconsin/Children's Hospital of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Beth Drolet, MD 414-266-1569 bdrolet@mcw.edu | |
Contact: Michael E Kelly, MD, PhD 414-456-4170 mekelly@mcw.edu | |
Principal Investigator: Beth Drolet, MD | |
Principal Investigator: Michael E Kelly, MD, PhD | |
Sub-Investigator: Paula North, MD, PhD |
Principal Investigator: | Beth Drolet, MD | Medical College of Wisconsin |
Principal Investigator: | Michael Kelly, MD, PhD | Medical College of Wisconsin |
Study ID Numbers: | 3429, #FDA-R-003429-01 |
Study First Received: | November 7, 2007 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00555464 |
Health Authority: | United States: Food and Drug Administration |
hemangioma, steroid, prednisolone, vincristine |
Prednisone Sodium phosphate Methylprednisolone Prednisolone Hemangioma |
Vincristine Methylprednisolone acetate Prednisolone acetate Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antimitotic Agents Protective Agents |
Neuroprotective Agents Glucocorticoids Hormones Pharmacologic Actions Neoplasms Autonomic Agents Therapeutic Uses Tubulin Modulators Neoplasms, Vascular Tissue Peripheral Nervous System Agents Antineoplastic Agents, Phytogenic Central Nervous System Agents |