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JOURNAL ONKOLOGIE – STUDIE
MEMMAT

Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma and ATRT

Rekrutierend

NCT-Nummer:
NCT01356290

Studienbeginn:
April 2014

Letztes Update:
30.01.2024

Wirkstoff:
Bevacizumab, Thalidomide, Celecoxib, Fenofibric acid, Etoposide, Cyclophosphamide, etoposide phosphate, Cytarabine

Indikation (Clinical Trials):
Ependymoma, Medulloblastoma, Recurrence

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 2

Sponsor:
Medical University of Vienna

Collaborator:
-

Studienleiter

Andreas Peyrl, MD
Principal Investigator
Medical University of Vienna
Monika Chocholous, MD
Study Chair
Medical University of Vienna

Kontakt

Andreas Peyrl, MD
Kontakt:
Phone: +43 1 40400
Phone (ext.): 32320
E-Mail: andreas.peyrl@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(3 von 22)

Ann & Robert H. Lurie Children's Hospital of Chicago
60611-2605 Chicago
United StatesAbgebrochen» Google-Maps
Dana-Farber Cancer Institute and Boston Children's Hospital
02215 Boston
United StatesAbgebrochen» Google-Maps
Helen DeVos Children's Hospital
48503 Grand Rapids
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Rebecca Loret de Mola
Phone: 616-267-0334
E-Mail: rebecca.loretdemola@helendevoschildrens.org» Ansprechpartner anzeigen
Medical University of Graz
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Elisabeth Hulla-Gumbsch
Phone: +43 316 385
Phone (ext.): 82686
E-Mail: elisabeth.hulla-gumbsch@klinikum-graz.at» Ansprechpartner anzeigen
Medical University of Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Yvonne Ennemoser, MSc
Phone: +43 512 504
Phone (ext.): 23605
E-Mail: yvonne.ennemoser@tirol-kliniken.at» Ansprechpartner anzeigen
Kepler Universitätsklinikum Med Campus IV
4020 Linz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Martina Winkler
Phone: +43 5 7680 84
Phone (ext.): 24302
E-Mail: martina.winkler@gespag.at» Ansprechpartner anzeigen
Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Andreas Peyrl, MD
Phone: +43 1 40400
Phone (ext.): 32320
E-Mail: andreas.peyrl@meduniwien.ac.at

Irene Slavc, MD
Phone: +43 1 40400
Phone (ext.): 32320
E-Mail: irene.slavc@meduniwien.ac.at» Ansprechpartner anzeigen
Onkologisk-hematologisk seksjon Barneklinikken Haukeland universitetssjukehus
5021 Bergen
NorwayRekrutierend» Google-Maps
Ansprechpartner:
Ingrid Torsvik
Phone: +4705300
Phone (ext.): +4755975147
E-Mail: ingrid.kristin.torsvik@helse-bergen.no» Ansprechpartner anzeigen
Hospital Infantil Universitario Nino Jesus
28009 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
Alvaro Lassaletta, MD, PhD
Phone: +34 915 035938
Phone (ext.): 377
E-Mail: alvaro.lassaletta@salud.madrid.org» Ansprechpartner anzeigen
Sahlgrenska Universitetssjukhuset
416 85 Göteborg
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Karin Fritzson
Phone: +46 31 343 58 65
E-Mail: karin.fritzson@vgregion.se

Anna Schröder- Håkansson
Phone: +46 31 343 58 65
E-Mail: anna.schroder_hakansson@vgregion.se» Ansprechpartner anzeigen
Universitetssjukhuset Linköping
581 85 Linköping
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Birgitta Hellström
Phone: +46 10 103 13 54
E-Mail: birgitta.hellstrom@regionostergotland.se

Pernilla Augustsson
Phone: +46 10-103 13 50
E-Mail: pernilla.augustsson@regionostergotland.se» Ansprechpartner anzeigen
Skånes universitetssjukhus
221 85 Lund
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Yvonne Håkansson
Phone: +46 46-17 80 64
E-Mail: Yvonne.Hakansson@skane.se

Simon Johansson
Phone: +46 46-17 80 64
E-Mail: simon.johansson@skane.se» Ansprechpartner anzeigen
Karolinska University Hospital
SE-171 76 Stockholm
SwedenRekrutierend» Google-Maps
Ansprechpartner:
Carina Rinaldo
Phone: +46 8 517 701 51
E-Mail: carina.rinaldo@karolinska.se

Yvonne Copeland
Phone: +46 8 517 724 84
E-Mail: yvonne.copeland-wahlo@karolinska.se» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Efficacy (Time Frame - 8 years):
Response rate (Complete remission, partial response, stable disease =[CR+PR+SD]/n) 6 months after start of antiangiogenic treatment



Secondary outcome:

1. Overall survival rate (Time Frame - 8 years):
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

2. Progression free survival rate (Time Frame - 8 years):
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.

3. Toxicity (Time Frame - 8 years):
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.

4. Feasibility (Time Frame - 6 years):
To evaluate the feasibility of achieving the prescribed drug doses given the reduced bone marrow tolerance after multiple relapses.

5. Quality of life (Time Frame - 8 years):
Quality of Life (QoL) will be evaluated by a generic quality of life instrument for children (the KINDL®-questionnaire).

6. Prognostic factors (Time Frame - 8 years):
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.

7. Angiogenic factors (Time Frame - 8 years):
To evaluate serum markers for in-vitro correlative studies of tumor response.

Geprüfte Regime

  • Bevacizumab (Avastin):
    10mg/kg, intravenous (iv), biweekly, 1 year
  • Thalidomide:
    3mg/kg, oral, daily, 1 year
  • Celecoxib:
    50-400mg, oral bid, daily, 1 year
  • Fenofibric acid:
    90mg/m2, oral, daily, 1 year
  • Etoposide:
    35-50 mg/m2, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
  • Cyclophosphamide:
    2.5mg/kg, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
  • Etoposide phosphate:
    0.5mg, intrathecal, day 1-5, every four weeks, alternating with intrathecal liposomal cytarabine, 1 year
  • Cytarabine:
    16-30mg, intrathecal, twice weekly for two weeks out of every four weeks, alternating with intrathecal etoposide phosphate, 1 year

Quelle: ClinicalTrials.gov


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