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Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors

RecruitingPhase 2Ages any - 19 YearsAllMedical University of Vienna
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In plain words

What the trial is, and whether it could suit you

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 stud

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion criteria for patients * Stratum I: Relapsed or progressive medulloblastoma - completed * Stratum II: Relapsed or progressive ependymoma (at least one site of untreated recurrent disease) * Stratum III: Relapsed or progressive ATRT (at least one site of untreated recurrent disease) * Stratum IV: Relapsed or progressive medulloblastoma (at least one site of untreated recurrent disease) * Stratum V: Relapsed or progressive CNS tumor of various histologies or patients with exclusion criteria or adult patients (explorative) * Histological confirmation at diagnosis or relapse Stratum IV: Confirmation of the medulloblastoma group by methylation; IDAT (Intensity Data; raw data of methylation array) * Female or male, aged from 0 to \<20 years (at time of original diagnosis) * Participants must have normal organ and bone marrow function (ALT \<5x institutional upper limit of normal, creatinine \<1.5x institutional upper limit of normal for age, WBC \>1000/mm3, platelets \> 20,000/mm3. Patients with values less than WBC 2000/mm3 or platelets 50,000/mm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol * Karnofsky performance status ≥50. For infants and children less than 12 years of age, the Lansky play scale ≥50% will be used * Written informed consent of patients and / or legal guardian Exclusion criteria for patients * VP- or subdural peritoneal shunt dependency (can be included in Stratum V) * Prior treatment with temozolomide/irinotecan (can be included in Stratum V) * Active infection, pregnancy or breast feeding * Treatment for current relapse (surgery may be performed before MEMMAT treatment; patients with sites of disease not irradiated are still eligible for the protocol) * Known hypersensitivity to any of the drugs in the protocol * Active peptic ulcer * Any significant cardiovascular disease not controlled by standard therapy e.g. systemic hypertension * Anticipation of the need for major elective surgery during the course of the study treatment * Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications * Non-healing surgical wound * A bone fracture that has not satisfactorily healed
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What it tests

  • Bevacizumab
  • Thalidomide
  • Celecoxib
  • Fenofibric acid
  • Etoposide
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Where

22 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, United States
Dana-Farber Cancer Institute and Boston Children's Hospital
Boston, United States
Helen DeVos Children's Hospital
Grand Rapids, United States
Dell Children's Medical Group SFC-HEM/ONC
Austin, United States
Medical University of Graz
Graz, Austria
Medical University of Innsbruck
Innsbruck, Austria
Kepler Universitätsklinikum Med Campus IV
Linz, Austria
Salzburger Universitätsklinikum
Salzburg, Austria

…and 14 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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