Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT (MEMMAT)
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ClinicalTrials.gov Identifier: NCT01356290 |
Recruitment Status :
Recruiting
First Posted : May 19, 2011
Last Update Posted : January 30, 2024
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Sponsor:
Medical University of Vienna
Information provided by (Responsible Party):
Andreas Peyrl, Medical University of Vienna
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 17, 2011 | ||||||||
First Posted Date ICMJE | May 19, 2011 | ||||||||
Last Update Posted Date | January 30, 2024 | ||||||||
Actual Study Start Date ICMJE | April 2014 | ||||||||
Estimated Primary Completion Date | April 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Efficacy [ Time Frame: 8 years ] Response rate (Complete remission, partial response, stable disease =[CR+PR+SD]/n) 6 months after start of antiangiogenic treatment
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Original Primary Outcome Measures ICMJE |
Efficacy [ Time Frame: 7 years ] Response rate (=[CR+PR+SD]/n) 6 months after start of antiangiogenic treatment
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT | ||||||||
Official Title ICMJE | A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT | ||||||||
Brief Summary | Patients with relapsed medulloblastoma, ependymoma and ATRT have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenetic therapy has emerged as new treatment option in solid malignancies. The frequent, metronomic schedule targets both proliferating tumor cells and endothelial cells, and minimizes toxicity. In this study the investigators will evaluate the use of biweekly intravenous bevacizumab in combination with five oral drugs (thalidomide, celecoxib, fenofibrate, and alternating cycles of daily low-dose oral etoposide and cyclophosphamide), augmented with alternating courses of intrathecal etoposide and cytarabine. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma and ATRT, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The primary objective of the MEMMAT trial is to evaluate the activity of this multidrug antiangiogenic approach in these heavily pretreated children and young adults. Additionally, progression-free survival (PFS), overall survival (OS), as well as feasibility and toxicity will be examined. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: 3 Strata (medulloblastoma - 40 patients; ependymoma - 30 patients; ATRT - 30 patients) Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | ||||||||
Publications * | Slavc I, Mayr L, Stepien N, Gojo J, Aliotti Lippolis M, Azizi AA, Chocholous M, Baumgartner A, Hedrich CS, Holm S, Sehested A, Leblond P, Dieckmann K, Haberler C, Czech T, Kool M, Peyrl A. Improved Long-Term Survival of Patients with Recurrent Medulloblastoma Treated with a "MEMMAT-like" Metronomic Antiangiogenic Approach. Cancers (Basel). 2022 Oct 19;14(20):5128. doi: 10.3390/cancers14205128. | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
100 | ||||||||
Original Estimated Enrollment ICMJE |
40 | ||||||||
Estimated Study Completion Date ICMJE | April 2026 | ||||||||
Estimated Primary Completion Date | April 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | up to 19 Years (Child, Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Austria, Czechia, Denmark, France, Norway, Spain, Sweden, United States | ||||||||
Removed Location Countries | Czech Republic | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01356290 | ||||||||
Other Study ID Numbers ICMJE | MUV-MEMMAT-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Andreas Peyrl, Medical University of Vienna | ||||||||
Original Responsible Party | Andreas Peyrl, MD, Medical University of Vienna | ||||||||
Current Study Sponsor ICMJE | Medical University of Vienna | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Medical University of Vienna | ||||||||
Verification Date | January 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |