Status:
COMPLETED
Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Conditions:
Intraluminal Pulmonary Vein Stenosis
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
We sought to develop a regimen that might successfully suppress myofibroblastic proliferation in infants and children with progressive pulmonary vein stenosis. A number of factors need to be considere...
Eligibility Criteria
Inclusion
- Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis.
- There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins.
- Evidence of myofibroblast neo-proliferation, if biopsies were obtained.
- Staging must include a complete cardiovascular evaluation including echocardiogram, and EKG.
- Accepted organ function includes:
- Creatinine \< 1.5 x normal for age.
- SGPT, Bilirubin \< 1.5 x normal for age.
- ANC ³ 1,500/mm3, Hemoglobin ³ 10g/dl, Platelets ³ 100,000/mm3
- Placement of a permanent central venous line. CVL access is necessary in all patients as vinblastine is a vesicant and will cause a tissue burn if infiltrated into the skin. Because a CVL may interfere with proper cardiac assessment in this patient population, the study physician will be made aware prior to the placement of a line.
- Patients may be listed for a lung transplant while enrolled on this study.
- All patients must have given written informed consent according to institutional guidelines.
Exclusion
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00215046
Start Date
March 1 2000
End Date
October 1 2006
Last Update
June 27 2011
Active Locations (2)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115