Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Ste⦠(NCT00891527) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
United States50 participantsStarted 2008-10
Plain-language 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.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 GleevecĀ® 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 GleevecĀ® and AvastinĀ®)
* 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