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

NCT00555464 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-06-11

Study results available
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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.

Conditions

  • Hemangioma

Interventions

DRUG

Vincristine

Vincristine (0.05 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.

DRUG

Prednisone

Prednisolone given at 3 mg/kg/day by mouth for 12 week

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Beth Drolet, MD · Medical College of Wisconsin

  • Michael Kelly, MD, PhD · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555464 on ClinicalTrials.gov