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NCT01356290 · ClinicalTrials.gov registry record · Phase 2
Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors
A Phase 2 study of Medulloblastoma Recurrent and Ependymoma Recurrent, sponsored by Medical University of Vienna.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 232
- Enrollment target
- 20
- Study locations
NCT01356290 is a Phase 2 study of Medulloblastoma Recurrent and Ependymoma Recurrent that is actively recruiting participants, run by Medical University of Vienna. The registered enrollment target is 232 participants, above the 136-participant average among 3 other Medulloblastoma Recurrent trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT01356290, a Phase 2 study of Medulloblastoma Recurrent and Ependymoma Recurrent, is actively recruiting participants, sponsored by Medical University of Vienna.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 232 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 136-participant average among 3 other Medulloblastoma Recurrent trials with a reported enrollment target (71% higher). The listed sponsor is Medical University of Vienna, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT01356290 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Illinois, Massachusetts.
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.
What interventions are being tested in trial NCT01356290?
The interventions under investigation include: Bevacizumab (DRUG), Etoposide (DRUG), Celecoxib (DRUG), Thalidomide (DRUG), Fenofibric acid (DRUG).
Who is sponsoring clinical trial NCT01356290?
This trial is sponsored by Medical University of Vienna, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.