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Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 19 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT01356290
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medical University of Vienna
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andreas Peyrl, MDMonika Chocholous, MD
Principal Investigator Affiliation Medical University of ViennaMedical University of Vienna
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Austria, Czechia, Denmark, France, Norway, Spain, Sweden, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Medulloblastoma Recurrent, Ependymoma Recurrent, ATRT Recurrent

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Terminated

Address

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

Chicago, Illinois, 60611-2605

Boston, Massachusetts

Status

Terminated

Address

Dana-Farber Cancer Institute and Boston Children's Hospital

Boston, Massachusetts, 02215

Helen DeVos Children's Hospital, Grand Rapids, Michigan

Status

Recruiting

Address

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 48503

Site Contact

Laura Paulsen

Laura.Paulsen@spectrumhealth.org

616-267-0334

Austin, Texas

Status

Recruiting

Address

Dell Children's Medical Group SFC-HEM/ONC

Austin, Texas, 78723

Site Contact

Ashley Ratcliffe

aeRatcliff@ascension.org

512-628-1900

International Sites

Medical University of Graz, Graz, Austria

Status

Recruiting

Address

Medical University of Graz

Graz, , 8036

Site Contact

Elisabeth Hulla-Gumbsch

elisabeth.hulla-gumbsch@klinikum-graz.at

+43 316 385 #82686

Medical University of Innsbruck, Innsbruck, Austria

Status

Recruiting

Address

Medical University of Innsbruck

Innsbruck, , 6020

Site Contact

Yvonne Ennemoser, MSc

yvonne.ennemoser@tirol-kliniken.at

+43 512 504 #23605

Linz, Austria

Status

Recruiting

Address

Kepler Universitätsklinikum Med Campus IV

Linz, , 4020

Site Contact

Martina Winkler

martina.winkler@gespag.at

+43 5 7680 84 #24302

Salzburger Universitätsklinikum, Salzburg, Austria

Status

Recruiting

Address

Salzburger Universitätsklinikum

Salzburg, , 5020

Site Contact

Agnes Gamper, MD

a.gamper@salk.at

+43 662 448257 #759

Medical University of Vienna, Vienna, Austria

Status

Recruiting

Address

Medical University of Vienna

Vienna, , 1090

Site Contact

Andreas Peyrl, MD

andreas.peyrl@meduniwien.ac.at

+43 1 40400 #32320

University Hospital Brno, Brno, Czechia

Status

Recruiting

Address

University Hospital Brno

Brno, , 61300

Site Contact

Alexandra Martincekova, MD

Martincekova.Alexandra@fnbrno.cz

+420532234755

Motol University Hospital Prague, Prague, Czechia

Status

Recruiting

Address

Motol University Hospital Prague

Prague, , 15006

Site Contact

Klara Hruba

klara.hruba@fnmotol.cz

+42 0224436401

University hospital Rigshospitalet, Copenhagen, Denmark

Status

Recruiting

Address

University hospital Rigshospitalet

Copenhagen, , 2100

Site Contact

Karsten Nysom, MD

karsten.nysom@regionh.dk

+45 3545 0809

Centre Oscar Lambret, Lille, France

Status

Terminated

Address

Centre Oscar Lambret

Lille, , 59037

Bergen, Norway

Status

Recruiting

Address

Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus

Bergen, , 5021

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Nino Jesus

Madrid, , 28009

Site Contact

Alvaro Lassaletta, MD, PhD

alvaro.lassaletta@salud.madrid.org

+34 915 035938 #377

Sahlgrenska Universitetssjukhuset, Göteborg, Sweden

Status

Recruiting

Address

Sahlgrenska Universitetssjukhuset

Göteborg, , 416 85

Site Contact

Karin Fritzson

karin.fritzson@vgregion.se

+46 31 343 58 65

Universitetssjukhuset Linköping, Linköping, Sweden

Status

Recruiting

Address

Universitetssjukhuset Linköping

Linköping, , 581 85

Skånes universitetssjukhus, Lund, Sweden

Status

Recruiting

Address

Skånes universitetssjukhus

Lund, , 221 85

Site Contact

Yvonne Håkansson

Yvonne.Hakansson@skane.se

+46 46-17 80 64

Karolinska University Hospital, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital

Stockholm, , SE-171 76

Site Contact

Carina Rinaldo

carina.rinaldo@karolinska.se

+46 8 517 701 51

Norrlands Universitetssjukhus, Umeå, Sweden

Status

Recruiting

Address

Norrlands Universitetssjukhus

Umeå, , 901 85

Site Contact

Marita Wikström-Larsson

Marita.Vikstrom.Larsson@vll.se

+46 90-785 02 44

Akademiska sjukhuset, Uppsala, Sweden

Status

Recruiting

Address

Akademiska sjukhuset

Uppsala, , 751 85

Site Contact

Katarina Vallin

katarina.vallin@akademiska.se

+46 18 611 34 94