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Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis

NCT00215046 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2011-06-27

No results posted yet for this study

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.

Conditions

  • Intraluminal Pulmonary Vein Stenosis

Interventions

DRUG

Vinblastine

drug - dosage and frequency is based on size of patient and response to treatment.

DRUG

Methotrexate

drug - dosage is based on size of patient and frequency and duration is based on response to treatment.

Sponsors & Collaborators

Principal Investigators

  • Mark W Kieran, MD,PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00215046 on ClinicalTrials.gov