A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

October 18, 2011

Primary Completion Date

February 5, 2016

Study Completion Date

January 29, 2020

Conditions
High Grade Glioma
Interventions
DRUG

Bevacizumab

10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days

RADIATION

Radiotherapy

Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase.

DRUG

Temozolomide (TMZ)

75 milligrams per square meter (mg/m\^2) daily continuous starting concomitantly with the first radiation fraction and ending with the last radiation fraction for a maximum number of treatment days = 49 days. During the TMZ adjuvant treatment phase and for participants from YPC: TMZ (150 to 200 mg/m\^2/day) x 12 cycles, 1st cycle 150 mg/m\^2/days 1-5, escalated to 200 mg/m\^2 on Days 1-5 from Cycle 2 onwards depending on the tolerance during the 1st cycle. Cycle length = 28 days.

Trial Locations (53)

1090

Medizinische Universität Wien, Vienna

1094

Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit, Budapest

2100

Rigshospitalet; Onkologisk Klinik, København Ø

2145

The Children's Hospital at Westmead, Westmead

3000

UZ Leuven Gasthuisberg, Leuven

4020

Kepler Universitätskliniken GmbH - Med Campus IV., Linz

8200

Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A, Aarhus N

13385

Hopital Timone Enfants; Onco Pediatrie, Marseille

15060

Fakultni Nemocnice V Motole, S.P., Prague

16147

Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia, Genoa

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

31059

Hopital Des Enfants; Service d Hemato-Oncologie, Toulouse

35056

CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique, Rennes

35128

Azienda Ospedaliera di Padova, Padua

37044

CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie, Tours

40138

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh, Bologna

42777

Hopital Nord;Consult Pediatrie, Saint-Priest-en-Jarez

46014

Hospital Universitario La Fe, Valencia

49033

Centre Hospitalier d'Angers; Service de cancérologie pédiatrique, Angers

54511

Hopital Brabois Enfants, Vandœuvre-lès-Nancy

59020

Centre Oscar Lambret; Service de Pediatrie, Lille

62500

Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice, Brno

63003

CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP), Clermont-Ferrand

67200

Hôpital Hautepierre, Strasbourg

69008

Centre Leon Berard, Lyon

75248

Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique, Paris

94805

Institut Gustave Roussy; Service Pediatrique, Villejuif

QLD 4101

Lady Cilento Children's Hospital; Oncology Services Group, Level 12b, South Brisbane

T3B 6A8

Alberta Children'S Hospital, Calgary

M5G 1X8

Hospital For Sick Children, Toronto

06200

Hopital Lenval; Service Hématologie Infantile, Nice

6525 GA

UMC St Radboud, Nijmegen

3015 GJ

Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology, Rotterdam

04-746

Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii, Warsaw

08950

Hospital Sant Joan De Deu, Esplugues de Llobregas

08035

Hospital Universitari Vall d'Hebron, Barcelona

416 85

Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus, Gothenburg

581 85

Universitetssjukhuset Linköping; Barn och Ungdomskliniken, Linköping

221 85

Skånes Universitetssjukhus, Lund

171 76

Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen, Solna

B4 6NH

Birmingham Childrens Hospital; Oncology Dept, Birmingham

BS2 8BJ

Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT, Bristol

CB2 0QQ

Addenbrookes Hospital; Paediatric Oncology Ward C2, Cambridge

EH91LF

Royal Hospital for Sick Children, Edinburgh

LS1 3EX

Leeds General Infirmary; Ward 35, Leeds

L12 2AP

Alder Hey Children's NHS Foundation Trust, Liverpool

NW1 2PG

University College London NHS Foundation Trust, London

WC1N 3JH

Great Ormond Street Hospital; Dept. Of Pediatric Oncology, London

M13 9WL

Royal Manchester Childrens Hospital, Manchester

NE1 4LP

Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NG7 2UH

Queens Medical Centre, Nottingham

SO16 6YD

Southampton General Hospital, Southampton

SM2 5PT

Royal Marsden Hospital; Pediatric Unit, Surrey

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01390948 - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma | Biotech Hunter | Biotech Hunter