Status:
COMPLETED
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
Lead Sponsor:
Boston Children's Hospital
Conditions:
Pulmonary Veno Occlusive Disease
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The objective of this study is to conduct a pilot study using biologic agents Avastin and Gleevec to treat progression of multivessel intraluminal pulmonary vein stenosis in children.
Detailed Description
Intraluminal pulmonary vein stenosis is rare but life threatening disease that affects both infants and children. It can be isolated to a single pulmonary vein, but most often occurs in multiple vesse...
Eligibility Criteria
Inclusion
- Eligibility Criteria: (Both groups)
- Evidence of intraluminal pulmonary vein stenosis in \> 1 vessel
- Evidence of myofibroblast neo-proliferation, if biopsies were obtained
- Acceptable organ function includes:
- Creatinine \< 1.5 x normal for age. Bilirubin \< 1.5 x normal for age. ALT \< or = 5x normal ANC \> or = 1,500/mm3, Hemoglobin \> or = 10g/dl, Platelets \> or = 100,000/mm3.
- Group A Eligibility Criteria: (begin treatment with Gleevec® only)
- Significant concomitant congenital heart defect
- Disease severity for each vessel Category 5 or lower or Category 6 or 7 in no more than 1 vessel
- Group B Eligibility Criteria: (begin treatment with Gleevec® and Avastin®)
- Primary PVS (i.e. without concomitant congenital heart defect or lung disease)
- Significant concomitant lung disease
- Patients with PVS and underlying CHD who have category 6 or 7 disease in at least 2 of their pulmonary veins even after surgical or cath-based interventions.
- Accepted organ function includes:
- Urine protein \< 1
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00891527
Start Date
October 1 2008
End Date
December 1 2015
Last Update
June 19 2019
Active Locations (1)
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1
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115