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

Phase 2 Terminated 8 enrolled Medical College of Wisconsin FDA Office of Orphan Products Development · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2007-11
Primary completion: 2012-12
Completion: 2012-12

Outcome

Outcome not reported

Stopped: “The introduction of oral propranolol as a highly efficacious agent for infantile hemangiomas”

Publications

Background Frieden IJ, Reese V, Cohen D. PHACE syndrome. The association of posterior fossa brain malformations, hemangiomas, arterial anomalies, coarctation of the aorta and cardiac defects, and eye abnormalities. Arch Dermatol. 1996 Mar;132(3):307-11. doi: 10.1001/archderm.132.3.307.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Prednisone	Other / unclassified	3 mg/kg	Oral
Subject	Vincristine	Small molecule	0.05 mg/kg	Intravenous