Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
Summary
To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the
treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will
contain children with multivessel pulmonary vein stenosis who do not have structural heart
disease, and Group 2 will consist of children with multivessel pulmonary vein stenosis and
concomitant structural heart disease.
The primary outcome variable for efficacy is patient status one year after the start of
treatment, where status is classified as either failure or success. Failure is defined as
death or evidence of progressive obstruction at any time over the course of treatment as
defined in the protocol. Success constitutes complete or partial response to treatment or
stability of disease. Secondary outcome variables for efficacy are survival, time from
diagnosis of pulmonary vein stenosis until failure, and change in patient classification on a
scale measuring the severity of the obstructive disease.
1.2 To assess the safety of vinblastine and methotrexate in the treatment of multivessel
pulmonary vein stenosis.
The primary outcome variable for safety is any occurrence of toxicity related to the
administration of the chemotherapeutic agents over the treatment period.
Phase:
Phase 2
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital