New treatment for children with recurrent brain tumors
A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
This study is testing a new treatment combining an intravenous drug with five oral medications to see if it can help children with recurring brain tumors live longer and feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 232 (estimated) |
| Ages | N/A to 19 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | cyclophosphamide, bevacizumab, chemotherapy |
| Locations | 22 sites (Chicago, Illinois and 21 other locations) |
| Trial ID | NCT01356290 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of antiangiogenic therapy using biweekly intravenous bevacizumab combined with five oral medications for children with relapsed medulloblastoma, ependymoma, and ATRT. The approach aims to target both tumor and endothelial cells while minimizing toxicity through a metronomic schedule. The study seeks to provide alternative treatment options for these patients, who currently have limited curative therapies available, with the goal of prolonging survival and maintaining a good quality of life.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 19 years with relapsed or progressive medulloblastoma, ependymoma, or ATRT.
Not a fit: Patients with active infections, VP-shunt dependency, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for children with recurrent brain tumors.
How similar studies have performed: Other studies have shown promise with antiangiogenic therapies in treating solid tumors, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 21 other locations
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Terminated)
- Dana-Farber Cancer Institute and Boston Children's Hospital — Boston, Massachusetts, United States (Terminated)
- Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States (Recruiting)
- Dell Children's Medical Group SFC-HEM/ONC — Austin, Texas, United States (Recruiting)
- Medical University of Graz — Graz, Austria (Recruiting)
- Medical University of Innsbruck — Innsbruck, Austria (Recruiting)
- Kepler Universitätsklinikum Med Campus IV — Linz, Austria (Recruiting)
- Salzburger Universitätsklinikum — Salzburg, Austria (Recruiting)
- Medical University of Vienna — Vienna, Austria (Recruiting)
- University Hospital Brno — Brno, Czechia (Recruiting)
- Motol University Hospital Prague — Prague, Czechia (Recruiting)
- University hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Centre Oscar Lambret — Lille, France (Terminated)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus — Bergen, Norway (Recruiting)
- Hospital Infantil Universitario Nino Jesus — Madrid, Spain (Recruiting)
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Recruiting)
- Universitetssjukhuset Linköping — Linköping, Sweden (Recruiting)
- Skånes universitetssjukhus — Lund, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Norrlands Universitetssjukhus — Umeå, Sweden (Recruiting)
- Akademiska sjukhuset — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Andreas Peyrl, MD — Medical University of Vienna
- Study coordinator: Andreas Peyrl, MD
- Email: andreas.peyrl@meduniwien.ac.at
- Phone: +43 1 40400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.