Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

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Medulloblastoma

Ependymoma

Disease Attributes

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

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Etoposide

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Bevacizumab

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Etoposide phosphate

Thalidomide

Celecoxib

Fenofibric acid

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Immunologic Factors

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Alkylating Agents

Antineoplastic Agents, Immunological

Growth Inhibitors

Enzyme Inhibitors

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Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Cyclooxygenase 2 Inhibitors

Cyclooxygenase Inhibitors

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Anticholesteremic Agents

Hypolipidemic Agents

10mg/kg, intravenous (iv), biweekly, 1 year

35-50 mg/m2, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year

2.5mg/kg, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year

0.5mg, intrathecal, day 1-5, every four weeks, alternating with intrathecal liposomal cytarabine, 1 year

16-30mg, intrathecal, twice weekly for two weeks out of every four weeks, alternating with intrathecal etoposide phosphate, 1 year

Andreas Peyrl, MD

Irene Slavc, MD

Rebecca Loret de Mola

Rebecca Loret De Mola, MD

Ashley Ratcliffe

Virginia Harrod, MD

Elisabeth Hulla-Gumbsch

Martin Benesch, MD

Yvonne Ennemoser, MSc

Roman Crazzolara, MD

Martina Winkler

Georg Ebetsberger, MD

Neil Jones, MD

Agnes Gamper, MD

Alexandra Martincekova, MD

Jaroslav Sterba, MD

Zdenek Pavelka, MD

Klara Hruba

David Sumerauer, MD

Karsten Nysom, MD

Pierre Leblond, MD

Ingrid Torsvik

Ingrid Torsvik, MD

Alvaro Lassaletta, MD, PhD

Karin Fritzson

Anna Schröder- Håkansson

Magnus Sabel, MD

Birgitta Lannering, Prof

Birgitta Hellström

Pernilla Augustsson

Irene Devenney, MD

Yvonne Håkansson

Simon Johansson

Helena Mörse, MD

Carina Rinaldo

Yvonne Copeland

Stefan Holm, MD

Marita Wikström-Larsson

Mattias Mattsson

Katarina Vallin

Anders Öberg, MD

Monika Chocholous, MD

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.

3 Strata (medulloblastoma - 40 patients; ependymoma - 30 patients; ATRT - 30 patients)

Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT

A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma, Ependymoma and ATRT

Response rate (Complete remission, partial response, stable disease =\[CR+PR+SD\]/n) 6 months after start of antiangiogenic treatment

The percentage of patients in the study who are alive for a certain period of time (6, 12, 24, and 36 months) after start of treatment with an antiangiogenic multidrug-regime

The percentage of patients in the study who are alive with a non-progressive disease for a certain period of time (6, 12, 24, and 36 months) after start of treatment with an antiangiogenic multidrug-regime.

To evaluate and document toxicities from chronic administration of these drugs at the doses prescribed in this protocol in patients with recurrent or progressive medulloblastoma. These will be descriptive in nature.

To evaluate the feasibility of achieving the prescribed drug doses given the reduced bone marrow tolerance after multiple relapses.

Quality of Life (QoL) will be evaluated by a generic quality of life instrument for children (the KINDL®-questionnaire).

To evaluate the influence of tumor biology(histologic subgroups, metastatic stage, age at first diagnosis \[\<3 years, \>3 years\]), age at start of antiangiogenic therapy, sex, duration of remission prior to antiangiogenic therapy, number of recurrences.

To evaluate serum markers for in-vitro correlative studies of tumor response.

Medical University of Vienna

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT	NCT01356290	Medulloblastoma... Ependymoma Recu... ATRT Recurrent	Bevacizumab Thalidomide Celecoxib Fenofibric acid Etoposide Cyclophosphamid... Etoposide phosp... Cytarabine	- 19 Years	Medical University of Vienna
Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT	NCT01356290	Medulloblastoma... Ependymoma Recu... ATRT Recurrent	Bevacizumab Thalidomide Celecoxib Fenofibric acid Etoposide Cyclophosphamid... Etoposide phosp... Cytarabine	- 19 Years	Medical University of Vienna

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