Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00891527
• Date of registration: 30/04/2009
• Prospective Registration: No
• Primary sponsor: Boston Children's Hospital
• Public title: Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis PVS
• Scientific title: Adjunct Targeted Biologic Inhibition in Children With Multivessel Intraluminal Pulmonary Vein Stenosis
• Date of first enrolment: October 2008
• Target sample size: 50
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00891527
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Kathy J Jenkins, MD, MPH
• Affiliation: Boston Children's Hospital

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Veno Occlusive Disease

Intervention(s)

Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)

Primary Outcome(s)

Number of Patients With Survival at 48 Weeks [Time Frame: 48 weeks]

Secondary Outcome(s)

Number of Patients With Disease Stabilization at 48 Weeks [Time Frame: 48 weeks]

Number of Patients With Disease Progression at 48 Weeks [Time Frame: 48 weeks]

Secondary ID(s)

07060249

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00891527