Testing small, frequent drug doses for children whose brain tumor came back
Official title: Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
Status: Recruiting. It is looking for patients now. Talk to your care team about whether it fits you.
The trial team last updated this record on .
The short version
This study is testing small, frequent doses of cancer drugs for children whose brain tumor came back or grew.
Read our full plain-language summary
What the trial team says
Patients with with recurrent or progressive medulloblastoma, ependymoma, atypical teratoid rhabdoid tumor (ATRT), and CNS tumors of various histologies have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenesis therapy has emerged as a new treatment option in solid malignancies. The frequent delivery of low doses of chemotherapy, referred to as metronomic or antiangiogenic chemotherapy, targets endothelial cells while reducing the toxicity associated with standard dose chemotherapy. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma, ATRT, and CNS tumors of various histologies, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The study will be conducted in independent strata. Stratum I (recurrent medulloblastoma): recently completed (Peyrl, 2023). Stratum II (recurrent ependymoma), III (recurrent ATRT) and V (recurrent CNS tumors of various histologies, patients with exclusion criteria and adult patients): The primary objective is to determine the response rate defined as the percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or lack of recurrence at 6 months after start of antiangiogenic treatment. Stratum IV (recurrent medulloblastoma): To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt. Additionally, PFS, OS, toxicity, QoL, performance status, predictive and prognostic markers will be examined. In stratum II and III, the study will follow an open label, single arm phase 2 design, and an open label randomized two-arm phase 2 design in Stratum IV, and the exploratory Stratum V.
Key facts
- Registry number
- NCT01356290
- Stage of testing
- Phase 2
- Conditions studied
- Medulloblastoma Recurrent, Ependymoma Recurrent, ATRT Recurrent, Rare CNS Tumor Recurrent
Where it is running
This trial lists 22 sites.
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Austria
- Medical University of Graz (Graz)
- Medical University of Innsbruck (Innsbruck)
- Kepler Universitätsklinikum Med Campus IV (Linz)
- Salzburger Universitätsklinikum (Salzburg)
- Medical University of Vienna (Vienna)
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Bergen
- Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus (Bergen)
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Czechia
- University Hospital Brno (Brno)
- Motol University Hospital Prague (Prague)
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Denmark
- University hospital Rigshospitalet (Copenhagen)
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France
- Centre Oscar Lambret (Lille)
- Centre Léon Bérard (Lyon)
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Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago (Chicago)
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Massachusetts
- Dana-Farber Cancer Institute and Boston Children's Hospital (Boston)
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Michigan
- Helen DeVos Children's Hospital (Grand Rapids)
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Spain
- Hospital Infantil Universitario Nino Jesus (Madrid)
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Sweden
- Sahlgrenska Universitetssjukhuset (Gothenburg)
- Universitetssjukhuset Linköping (Linköping)
- Skånes universitetssjukhus (Lund)
- Karolinska University Hospital (Stockholm)
- Norrlands Universitetssjukhus (Umeå)
- Akademiska sjukhuset (Uppsala)
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Texas
- Dell Children's Medical Group SFC-HEM/ONC (Austin)
How to use this
Talk to your care team first. They know your history and can tell you whether this trial is worth your time.
Joining a trial is always your choice. A trial is a test, not a proven treatment. Being in one is not a promise that it will help you.
This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.