Pulmonary Veno Occlusive DiseasePhase 1/2PVSNCT00891527
Pilot Study Using Avastin and Gleevec to Treat the Progression of Intraluminal Pulmonary Vein Stenosis
A Phase 1/2 study testing Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec) in people with Pulmonary Veno Occlusive Disease, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Veno Occlusive Disease
- What is being tested?
- Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Childrens Hospital
Boston, Massachusetts, 02115
About this study
Official title: Adjunct Targeted Biologic Inhibition in Children With Multivessel Intraluminal Pulmonary Vein Stenosis
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.
Read the 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 vessels simultaneously. It can occur as a complicating feature of complex congenital heart disease, but can also occur in isolation in infants with otherwise normal hearts. Response to conventional surgical or transcatheter-based therapies is usually short-lived. Typically within 3 to 4 weeks the obstruction recurs. Repeat surgical attempts provide only temporary relief and eventually all of these infants die without lung transplantation.
While the cause of this disease is unknown the mechanism of progressive obstruction has recently been determined through biopsy and autopsy reviews to result from neo-proliferative cells identified as myofibroblasts which have cell markers VEGF and PDGF. Chemotherapeutic agents Avastin and Gleevec have shown to inhibit myo-proliferation through these markers. The overall objective of this protocol is to conduct a pilot study using the biologic agents Avastin and Gleevec to treat progression of intraluminal pulmonary vein stenosis (PVS). From this pilot group of 10 patients we will attempt to provide an enhanced characterization of the progressive primary disease process, as well as its secondary manifestations. Results will be analyzed descriptively; data gathered from this pilot study will be used to inform further study examining safety and efficacy outcomes. Initial study was limited to 10 patients, but was later expanded to 50 enrolled patients.
The study objectives will be accomplished by achievement of the following Specific Aims:
- To describe the feasibility of administration of Gleevec® with or without Avastin® to treat the progression of intraluminal PVS in patients with multivessel disease. Patients with PVS in conjunction with congenital heart disease (CHD) will receive Gleevec® alone, with Avastin® added if significant progression occurs; patients with primary PVS and PVS in conjunction with lung disease will be treated with both drugs simultaneously.
- To characterize the time to progression and the proportion of patients who survive 48 weeks after enrollment.
- To describe the toxicity associated with administration of Gleevec® with or without Avastin® during a 48 week course of treatment among patients with multivessel PVS.
Patients will be treated with Gleevec® with or without Avastin® for a period of 48 weeks, and will be followed until 72 weeks. Clinical status will be assessed by serial lab testing, monthly echocardiography and lung scans, and baseline and q24 week CT angiography or angiography. Obstruction of individual pulmonary veins will be assessed using a standard score, and patients will be classified as stabilized, recurred or progressed based on changes in the individual vein scores.
- Conditions
- Pulmonary Veno Occlusive Disease
- Being tested
- Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)
- Keywords
- Pulmonary Vein Stenosis,, Avastin and Gleevec,, Targeting VEGF and PDGF
- Medical subject headings
- Pulmonary Veno-Occlusive Disease, Stenosis, Pulmonary Vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)Drug
Also called Bevacizumab (rhuMAb VEGF, Avastin), NSC 704865, Imatinib Mesylate (Gleevec, STI571), NSC 716051, IND 61,135
Imatinib Mesylate Orange to grayish orange, opaque, 100mg capsules dissolved in 50-100mls of mineral water or apple juice. Given at 340mg/m2 once daily, preferably with a meal.
Bevacizumab Clear to slightly opalescent liquid. Given at 10mg/kg once every 2 weeks IV. The calculated dose should be placed in an IV bag and diluted with 0.9% sodium chloride to obtain a final volume of 25-100mls. The vials contain no antibacterial preservatives. Once diluted, must be administered within 8 hrs. Initially administered over 90 mins. If no adverse reactions occur, 2nd dose administered over 60 mins. If still no adverse reactions, subsequent doses administered over 30 mins. If infusion-related adverse reactions occur, further infusions administered over the shortest period that was well tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Avastin and/or Gleevec | Experimental | Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab). Receives: Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Survival at 48 Weeks
Measured: 48 weeks
Secondary outcomes (2)
Number of Patients With Disease Progression at 48 Weeks
Patients will be classified as having disease progression if at least 2 pulmonary veins have significantly worsened at 48 weeks. This determination is based on the study defined Pulmonary Vein Status Scale, which categorizes pulmonary veins on a scale from "1- None: No narrowing of the luminal contour," to "7- Distal atretic: Complete obliteration of the luminal contour extending >5mm within the vessel segment."
Measured: 48 weeks
Number of Patients With Disease Stabilization at 48 Weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startOct 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Veno Occlusive DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathy Jenkins, Boston Children's Hospital
- Investigators
- Kathy J Jenkins, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891527
- Sponsor's protocol ID
- 07060249
- Acronym
- PVS
- Status last verified
- Jun 2019
- First submitted
- 30 Apr 2009
- Last updated
- 19 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Bini RM, Cleveland DC, Ceballos R, Bargeron LM Jr, Pacifico AD, Kirklin JW. Congenital pulmonary vein stenosis. Am J Cardiol. 1984 Aug 1;54(3):369-75. doi: 10.1016/0002-9149(84)90199-1.
PubMed 6465018Webber SA, de Souza E, Patterson MW. Pulsed wave and color Doppler findings in congenital pulmonary vein stenosis. Pediatr Cardiol. 1992 Apr;13(2):112-5. doi: 10.1007/BF00798218.
PubMed 1614915Adey CK, Soto B, Shin MS. Congenital pulmonary vein stenosis: a radiographic study. Radiology. 1986 Oct;161(1):113-7. doi: 10.1148/radiology.161.1.3763853.
PubMed 3763853Mendelsohn AM, Bove EL, Lupinetti FM, Crowley DC, Lloyd TR, Fedderly RT, Beekman RH 3rd. Intraoperative and percutaneous stenting of congenital pulmonary artery and vein stenosis. Circulation. 1993 Nov;88(5 Pt 2):II210-7.
PubMed 8222156Driscoll DJ, Hesslein PS, Mullins CE. Congenital stenosis of individual pulmonary veins: clinical spectrum and unsuccessful treatment by transvenous balloon dilation. Am J Cardiol. 1982 May;49(7):1767-72. doi: 10.1016/0002-9149(82)90257-0.
PubMed 6211076Bahl VK, Chandra S, Mishra S. Congenital stenosis of isolated pulmonary vein: role of retrograde pulmonary vein catheterization. Int J Cardiol. 1997 Jun 27;60(1):103-5. doi: 10.1016/s0167-5273(97)02972-0.
PubMed 9209947Mendeloff EN, Spray TL, Huddleston CB, Bridges ND, Canter CB, Mallory GB Jr. Lung transplantation for congenital pulmonary vein stenosis. Ann Thorac Surg. 1995 Oct;60(4):903-6; discussion 907. doi: 10.1016/0003-4975(95)00543-t.
PubMed 7574992Martinez-Climent J, Cavalle T, Ferris Tortajada J. Non-malignant tumors that can mimic cancer during the neonatal period. Eur J Pediatr Surg. 1995 Jun;5(3):156-9. doi: 10.1055/s-2008-1066193.
PubMed 7547802Herman TE, Siegel MJ. Special imaging casebook. Infantile myofibromatosis: solitary and multifocal varieties. J Perinatol. 1995 May-Jun;15(3):250-2. No abstract available.
PubMed 7666279Davies RS, Carty H, Pierro A. Infantile myofibromatosis--a review. Br J Radiol. 1994 Jul;67(799):619-23. doi: 10.1259/0007-1285-67-799-619.
PubMed 8061994Hutchinson L, Sismanis A, Ward J, Price L. Infantile myofibromatosis of the temporal bone: a case report. Am J Otol. 1991 Jan;12(1):64-6.
PubMed 2012194Goldberg NS, Bauer BS, Kraus H, Crussi FG, Esterly NB. Infantile myofibromatosis: a review of clinicopathology with perspectives on new treatment choices. Pediatr Dermatol. 1988 Feb;5(1):37-46. doi: 10.1111/j.1525-1470.1988.tb00882.x.
PubMed 3288983Duffy MT, Harris M, Hornblass A. Infantile myofibromatosis of orbital bone. A case report with computed tomography, magnetic resonance imaging, and histologic findings. Ophthalmology. 1997 Sep;104(9):1471-4. doi: 10.1016/s0161-6420(97)30114-6.
PubMed 9307643Coffin CM, Neilson KA, Ingels S, Frank-Gerszberg R, Dehner LP. Congenital generalized myofibromatosis: a disseminated angiocentric myofibromatosis. Pediatr Pathol Lab Med. 1995 Jul-Aug;15(4):571-87. doi: 10.3109/15513819509026993.
PubMed 8597844Hasegawa M, Kida S, Yamashima T, Yamashita J, Takakuwa S. Multicentric infantile myofibromatosis in the cranium: case report. Neurosurgery. 1995 Jun;36(6):1200-3. doi: 10.1227/00006123-199506000-00023.
PubMed 7644004
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Targeted Biologic Inhibition in Children With Multivessel Intraluminal Pulmonary Vein Stenosis
- ClinicalTrials.gov ID
- NCT00891527
- Acronym / sponsor ID
- PVS / 07060249
- Conditions
- Pulmonary Veno Occlusive Disease
- Keywords
- Pulmonary Vein Stenosis,, Avastin and Gleevec,, Targeting VEGF and PDGF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- Oct 2008 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 May 2009 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 vessels simultaneously. It can occur as a complicating feature of complex congenital heart disease, but can also occur in isolation in infants with otherwise normal hearts. Response to conventional surgical or transcatheter-based therapies is usually short-lived. Typically within 3 to 4 weeks the obstruction recurs. Repeat surgical attempts provide only temporary relief and eventually all of these infants die without lung transplantation.
While the cause of this disease is unknown the mechanism of progressive obstruction has recently been determined through biopsy and autopsy reviews to result from neo-proliferative cells identified as myofibroblasts which have cell markers VEGF and PDGF. Chemotherapeutic agents Avastin and Gleevec have shown to inhibit myo-proliferation through these markers. The overall objective of this protocol is to conduct a pilot study using the biologic agents Avastin and Gleevec to treat progression of intraluminal pulmonary vein stenosis (PVS). From this pilot group of 10 patients we will attempt to provide an enhanced characterization of the progressive primary disease process, as well as its secondary manifestations. Results will be analyzed descriptively; data gathered from this pilot study will be used to inform further study examining safety and efficacy outcomes. Initial study was limited to 10 patients, but was later expanded to 50 enrolled patients.
The study objectives will be accomplished by achievement of the following Specific Aims:
- To describe the feasibility of administration of Gleevec® with or without Avastin® to treat the progression of intraluminal PVS in patients with multivessel disease. Patients with PVS in conjunction with congenital heart disease (CHD) will receive Gleevec® alone, with Avastin® added if significant progression occurs; patients with primary PVS and PVS in conjunction with lung disease will be treated with both drugs simultaneously.
- To characterize the time to progression and the proportion of patients who survive 48 weeks after enrollment.
- To describe the toxicity associated with administration of Gleevec® with or without Avastin® during a 48 week course of treatment among patients with multivessel PVS.
Patients will be treated with Gleevec® with or without Avastin® for a period of 48 weeks, and will be followed until 72 weeks. Clinical status will be assessed by serial lab testing, monthly echocardiography and lung scans, and baseline and q24 week CT angiography or angiography. Obstruction of individual pulmonary veins will be assessed using a standard score, and patients will be classified as stabilized, recurred or progressed based on changes in the individual vein scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin and/or Gleevec | Experimental | Drug: Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec)Also: Bevacizumab (rhuMAb VEGF, Avastin), NSC 704865, Imatinib Mesylate (Gleevec, STI571), NSC 716051, IND 61,135Imatinib Mesylate Orange to grayish orange, opaque, 100mg capsules dissolved in 50-100mls of mineral water or apple juice. Given at 340mg/m2 once daily, preferably with a meal. Bevacizumab Clear to slightly opalescent liquid. Given at 10mg/kg once every 2 weeks IV. The calculated dose should be placed in an IV bag and diluted with 0.9% sodium chloride to obtain a final volume of 25-100mls. The vials contain no antibacterial preservatives. Once diluted, must be administered within 8 hrs. Initially administered over 90 mins. If no adverse reactions occur, 2nd dose administered over 60 mins. If still no adverse reactions, subsequent doses administered over 30 mins. If infusion-related adverse reactions occur, further infusions administered over the shortest period that was well tolerated. | Drug | Avastin and/or Gleevec |
Primary outcome
Number of Patients With Survival at 48 Weeks
Time frame: 48 weeks
2 secondary outcomes
Number of Patients With Disease Progression at 48 Weeks
Time frame: 48 weeks
Number of Patients With Disease Stabilization at 48 Weeks
Time frame: 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 6465018Bini RM, Cleveland DC, Ceballos R, Bargeron LM Jr, Pacifico AD, Kirklin JW. Congenital pulmonary vein stenosis. Am J Cardiol. 1984 Aug 1;54(3):369-75. doi: 10.1016/0002-9149(84)90199-1.
- Background: PubMed 1614915Webber SA, de Souza E, Patterson MW. Pulsed wave and color Doppler findings in congenital pulmonary vein stenosis. Pediatr Cardiol. 1992 Apr;13(2):112-5. doi: 10.1007/BF00798218.
- Background: PubMed 3763853Adey CK, Soto B, Shin MS. Congenital pulmonary vein stenosis: a radiographic study. Radiology. 1986 Oct;161(1):113-7. doi: 10.1148/radiology.161.1.3763853.
- Background: PubMed 8222156Mendelsohn AM, Bove EL, Lupinetti FM, Crowley DC, Lloyd TR, Fedderly RT, Beekman RH 3rd. Intraoperative and percutaneous stenting of congenital pulmonary artery and vein stenosis. Circulation. 1993 Nov;88(5 Pt 2):II210-7.
- Background: PubMed 6211076Driscoll DJ, Hesslein PS, Mullins CE. Congenital stenosis of individual pulmonary veins: clinical spectrum and unsuccessful treatment by transvenous balloon dilation. Am J Cardiol. 1982 May;49(7):1767-72. doi: 10.1016/0002-9149(82)90257-0.
- Background: PubMed 9209947Bahl VK, Chandra S, Mishra S. Congenital stenosis of isolated pulmonary vein: role of retrograde pulmonary vein catheterization. Int J Cardiol. 1997 Jun 27;60(1):103-5. doi: 10.1016/s0167-5273(97)02972-0.
- Background: PubMed 7574992Mendeloff EN, Spray TL, Huddleston CB, Bridges ND, Canter CB, Mallory GB Jr. Lung transplantation for congenital pulmonary vein stenosis. Ann Thorac Surg. 1995 Oct;60(4):903-6; discussion 907. doi: 10.1016/0003-4975(95)00543-t.
- Background: PubMed 7547802Martinez-Climent J, Cavalle T, Ferris Tortajada J. Non-malignant tumors that can mimic cancer during the neonatal period. Eur J Pediatr Surg. 1995 Jun;5(3):156-9. doi: 10.1055/s-2008-1066193.
- Background: PubMed 7666279Herman TE, Siegel MJ. Special imaging casebook. Infantile myofibromatosis: solitary and multifocal varieties. J Perinatol. 1995 May-Jun;15(3):250-2. No abstract available.
- Background: PubMed 8061994Davies RS, Carty H, Pierro A. Infantile myofibromatosis--a review. Br J Radiol. 1994 Jul;67(799):619-23. doi: 10.1259/0007-1285-67-799-619.
- Background: PubMed 2012194Hutchinson L, Sismanis A, Ward J, Price L. Infantile myofibromatosis of the temporal bone: a case report. Am J Otol. 1991 Jan;12(1):64-6.
- Background: PubMed 3288983Goldberg NS, Bauer BS, Kraus H, Crussi FG, Esterly NB. Infantile myofibromatosis: a review of clinicopathology with perspectives on new treatment choices. Pediatr Dermatol. 1988 Feb;5(1):37-46. doi: 10.1111/j.1525-1470.1988.tb00882.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy J Jenkins, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bevacizumab (Avastin) and Imatinib Mesylate (Gleevec) in people with Pulmonary Veno Occlusive Disease, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Survival at 48 Weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00891527, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.