Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors (NCT01356290)
A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
Age range: Not specified to 19 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Dana-Farber Cancer Institute and Boston Children's Hospital — Boston, Massachusetts
- Helen DeVos Children's Hospital — Grand Rapids, Michigan
- Dell Children's Medical Group SFC-HEM/ONC — Austin, Texas
- 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,
- Norrlands Universitetssjukhus — Umeå,
- Akademiska sjukhuset — Uppsala,
📞 Contact the Study Coordinator
Phone: +43 1 40400
Email: andreas.peyrl@meduniwien.ac.at
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.