Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
Recruiting now · Phase 2
Conditions studied: Medulloblastoma Recurrent, Ependymoma Recurrent, ATRT Recurrent, Rare CNS Tumor Recurrent
In brief
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
- Study ID
- NCT01356290
- Run by
- Medical University of Vienna
- People needed
- 232
- Starts
- 2014-04-01
- Expected to finish
- 2030-04-01
- Last updated by the study team
- 2026-02-23
Who can join
Age: any, up to 19. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Akademiska sjukhuset — Uppsala, Sweden (enrolling)
- Skånes universitetssjukhus — Lund, Sweden (enrolling)
- Karolinska University Hospital — Stockholm, Sweden (enrolling)
- Norrlands Universitetssjukhus — Umeå, Sweden (enrolling)
- Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States (enrolling)
- Dell Children's Medical Group SFC-HEM/ONC — Austin, Texas, United States (enrolling)
- Medical University of Graz — Graz, Austria (enrolling)
- Medical University of Innsbruck — Innsbruck, Austria (enrolling)
- Kepler Universitätsklinikum Med Campus IV — Linz, Austria (enrolling)
- Salzburger Universitätsklinikum — Salzburg, Austria (enrolling)
- Medical University of Vienna — Vienna, Austria (enrolling)
- University Hospital Brno — Brno, Czechia (enrolling)
- Motol University Hospital Prague — Prague, Czechia (enrolling)
- University hospital Rigshospitalet — Copenhagen, Denmark (enrolling)
- Centre Léon Bérard — Lyon, France (enrolling)
- Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus — Bergen, Norway (enrolling)
- Hospital Infantil Universitario Nino Jesus — Madrid, Spain (enrolling)
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (enrolling)
- Universitetssjukhuset Linköping — Linköping, Sweden (enrolling)
- Dana-Farber Cancer Institute and Boston Children's Hospital — Boston, Massachusetts, United States
- Centre Oscar Lambret — Lille, France
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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