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Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
NCT01356290 · View on ClinicalTrials.gov ↗
Study Summary
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-
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Etoposide
- DRUG Celecoxib
- DRUG Thalidomide
- DRUG Fenofibric acid
Study Locations (20)
Other
- Medical University of Graz — Graz
- Medical University of Innsbruck — Innsbruck
- Kepler Universitätsklinikum Med Campus IV — Linz
- Salzburger Universitätsklinikum — Salzburg
- Medical University of Vienna — Vienna
- University Hospital Brno — Brno
- Motol University Hospital Prague — Prague
- University hospital Rigshospitalet — Copenhagen
- Centre Oscar Lambret — Lille
- Centre Léon Bérard — Lyon
- Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus — Bergen
- Hospital Infantil Universitario Nino Jesus — Madrid
- Sahlgrenska Universitetssjukhuset — Gothenburg
- Universitetssjukhuset Linköping — Linköping
- Skånes universitetssjukhus — Lund
- Karolinska University Hospital — Stockholm
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Massachusetts
- Dana-Farber Cancer Institute and Boston Children's Hospital — Boston
Michigan
- Helen DeVos Children's Hospital — Grand Rapids
Texas
- Dell Children's Medical Group SFC-HEM/ONC — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2014-04 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01356290
The ClinicalTrials.gov registry entry for NCT01356290 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of Vienna, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Medulloblastoma Recurrent appearing as the primary indexed condition, and to 5 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01356290 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Other, Illinois, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01356290 about?
NCT01356290 is a clinical study titled "Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors". 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...
What is the current status of trial NCT01356290?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 232 participants. The study started on 2014-04. Estimated completion is 2030-04.
What conditions does trial NCT01356290 study?
This clinical trial studies the following conditions: Medulloblastoma Recurrent, Ependymoma Recurrent, ATRT Recurrent, Rare CNS Tumor Recurrent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01356290?
The interventions under investigation include: Bevacizumab (DRUG), Etoposide (DRUG), Celecoxib (DRUG), Thalidomide (DRUG), Fenofibric acid (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01356290?
This trial is sponsored by Medical University of Vienna, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01356290 being conducted?
This trial has 20 study locations across Illinois, Massachusetts, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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