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Antiangiogenic Therapy for Children with Recurrent Medulloblastoma, Ependymoma and ATRT

NCT ID: NCT01356290

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2030-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Medulloblastoma Recurrent Ependymoma Recurrent ATRT Recurrent

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

TREATMENT

Blinding Strategy

NONE

Interventions

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Bevacizumab

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

Intervention Type DRUG

Thalidomide

3mg/kg, oral, daily, 1 year

Intervention Type DRUG

Celecoxib

50-400mg, oral bid, daily, 1 year

Intervention Type DRUG

Fenofibric acid

90mg/m2, oral, daily, 1 year

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Etoposide phosphate

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

Intervention Type DRUG

Cytarabine

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

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Relapsed or progressive medulloblastoma, ependymoma or ATRT (at least one site of untreated recurrent disease)
* Histological confirmation of medulloblastoma, ependymoma or ATRT at diagnosis or relapse
* 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 parents

Exclusion Criteria

* Active infection
* VP-shunt dependency
* Pregnancy or breast feeding
* Conventional chemotherapy, antiangiogenic treatment or complete irradiation of all disease for current relapse (surgery may be performed before antiangiogenic 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 controled 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
Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Andreas Peyrl

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Peyrl, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Monika Chocholous, MD

Role: STUDY_CHAIR

Medical University of Vienna

Locations

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Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status TERMINATED

Dana-Farber Cancer Institute and Boston Children's Hospital

Boston, Massachusetts, United States

Site Status TERMINATED

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Dell Children's Medical Group SFC-HEM/ONC

Austin, Texas, United States

Site Status RECRUITING

Medical University of Graz

Graz, , Austria

Site Status RECRUITING

Medical University of Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Kepler Universitätsklinikum Med Campus IV

Linz, , Austria

Site Status RECRUITING

Salzburger Universitätsklinikum

Salzburg, , Austria

Site Status RECRUITING

Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

University Hospital Brno

Brno, , Czechia

Site Status RECRUITING

Motol University Hospital Prague

Prague, , Czechia

Site Status RECRUITING

University hospital Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status TERMINATED

Centre Léon Bérard

Lyon, , France

Site Status RECRUITING

Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus

Bergen, Bergen, Norway

Site Status RECRUITING

Hospital Infantil Universitario Nino Jesus

Madrid, , Spain

Site Status RECRUITING

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status RECRUITING

Universitetssjukhuset Linköping

Linköping, , Sweden

Site Status RECRUITING

Skånes universitetssjukhus

Lund, , Sweden

Site Status RECRUITING

Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Norrlands Universitetssjukhus

Umeå, , Sweden

Site Status RECRUITING

Akademiska sjukhuset

Uppsala, , Sweden

Site Status RECRUITING

Countries

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United States Austria Czechia Denmark France Norway Spain Sweden

Central Contacts

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Andreas Peyrl, MD

Role: CONTACT

[email protected]
+43 1 40400 ext. 32320

Irene Slavc, MD

Role: CONTACT

[email protected]
+43 1 40400 ext. 32320

Facility Contacts

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Rebecca Loret de Mola

Role: primary

[email protected]
616 267 0334

Rebecca Loret De Mola, MD

Role: backup

Ashley Ratcliffe

Role: primary

[email protected]
512 628 1900

Virginia Harrod, MD

Role: backup

Elisabeth Hulla-Gumbsch

Role: primary

[email protected]
+43 316 385 ext. 82686

Martin Benesch, MD

Role: backup

Yvonne Ennemoser, MSc

Role: primary

[email protected]
+43 512 504 ext. 23605

Roman Crazzolara, MD

Role: backup

Martina Winkler

Role: primary

[email protected]
+43 5 7680 84 ext. 24302

Georg Ebetsberger, MD

Role: backup

Neil Jones, MD

Role: primary

[email protected]
+43 662 448257 ext. 759

Agnes Gamper, MD

Role: backup

Andreas Peyrl, MD

Role: primary

[email protected]
+43 1 40400 ext. 32320

Irene Slavc, MD

Role: backup

[email protected]
+43 1 40400 ext. 32320

Andreas Peyrl, MD

Role: backup

Irene Slavc, MD

Role: backup

Alexandra Martincekova, MD

Role: primary

[email protected]
+420532234755

Jaroslav Sterba, MD

Role: backup

Zdenek Pavelka, MD

Role: backup

Klara Hruba

Role: primary

[email protected]
+42 0224436401

David Sumerauer, MD

Role: backup

Karsten Nysom, MD

Role: primary

[email protected]
+45 3545 0809

Karsten Nysom, MD

Role: backup

Pierre Leblond, MD

Role: primary

[email protected]
+33 4 78 78 28 28

Pierre Leblond, MD

Role: backup

Ingrid Torsvik

Role: primary

[email protected]
+4705300 ext. +4755975147

Ingrid Torsvik, MD

Role: backup

Alvaro Lassaletta, MD, PhD

Role: primary

[email protected]
+34 915 035938 ext. 377

Alvaro Lassaletta, MD, PhD

Role: backup

Karin Fritzson

Role: primary

[email protected]
+46 31 343 58 65

Anna Schröder- Håkansson

Role: backup

[email protected]
+46 31 343 58 65

Magnus Sabel, MD

Role: backup

Birgitta Lannering, Prof

Role: backup

Birgitta Hellström

Role: primary

[email protected]
+46 10 103 13 54

Pernilla Augustsson

Role: backup

[email protected]
+46 10-103 13 50

Irene Devenney, MD

Role: backup

Yvonne Håkansson

Role: primary

[email protected]
+46 46-17 80 64

Simon Johansson

Role: backup

[email protected]
+46 46-17 80 64

Helena Mörse, MD

Role: backup

Carina Rinaldo

Role: primary

[email protected]
+46 8 517 701 51

Yvonne Copeland

Role: backup

[email protected]
+46 8 517 724 84

Stefan Holm, MD

Role: backup

Marita Wikström-Larsson

Role: primary

[email protected]
+46 90-785 02 44

Mattias Mattsson

Role: backup

Katarina Vallin

Role: primary

[email protected]
+46 18 611 34 94

Anders Öberg, MD

Role: backup

References

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Peyrl A, Chocholous M, Sabel M, Lassaletta A, Sterba J, Leblond P, Nysom K, Torsvik I, Chi SN, Perwein T, Jones N, Holm S, Nyman P, Morse H, Oberg A, Weiler-Wichtl L, Leiss U, Haberler C, Schmook MT, Mayr L, Dieckmann K, Kool M, Gojo J, Azizi AA, Andre N, Kieran M, Slavc I. Sustained Survival Benefit in Recurrent Medulloblastoma by a Metronomic Antiangiogenic Regimen: A Nonrandomized Controlled Trial. JAMA Oncol. 2023 Dec 1;9(12):1688-1695. doi: 10.1001/jamaoncol.2023.4437.

Reference Type DERIVED
PMID: 37883081 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36291912 (View on PubMed)

Other Identifiers

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MUV-MEMMAT-01

Identifier Type: -

Identifier Source: org_study_id

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