Spots Global Cancer Trial Database for A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
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Trial Identification
Brief Title: A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
Official Title: A Phase II Open-Label, Randomized, Multi-Centre Comparative Study Of Bevacizumab-Based Therapy In Paediatric Patients With Newly Diagnosed Supratentorial, Infratentorial Cerebellar, or Peduncular High-Grade Glioma
Study ID: NCT01390948
Conditions
Study Description
Brief Summary: This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children \>/= 6 months and \< 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.
Detailed Description:
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Lady Cilento Children's Hospital; Oncology Services Group, Level 12b, South Brisbane, Queensland, Australia
Kepler Universitätskliniken GmbH - Med Campus IV., Linz, , Austria
Medizinische Universität Wien, Wien, , Austria
UZ Leuven Gasthuisberg, Leuven, , Belgium
Alberta Children'S Hospital, Calgary, Alberta, Canada
Hospital For Sick Children, Toronto, Ontario, Canada
Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice, Brno, , Czechia
Fakultni Nemocnice V Motole, S.P., Prague, , Czechia
Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A, Aarhus N, , Denmark
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Centre Hospitalier d'Angers; Service de cancérologie pédiatrique, Angers, , France
CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP), Clermont Ferrand, , France
Centre Oscar Lambret; Service de Pediatrie, Lille, , France
Centre Leon Berard, Lyon, , France
Hopital Timone Enfants; Onco Pediatrie, Marseille, , France
Hopital Lenval; Service Hématologie Infantile, Nice, , France
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique, Paris, , France
CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique, Rennes, , France
Hopital Nord;Consult Pediatrie, St Priest En Jarez, , France
Hôpital Hautepierre, Strasbourg, , France
Hopital Des Enfants; Service d Hemato-Oncologie, Toulouse, , France
CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie, Tours, , France
Hopital Brabois Enfants, Vandoeuvre-les-Nancy cedex, , France
Institut Gustave Roussy; Service Pediatrique, Villejuif, , France
Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit, Budapest, , Hungary
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh, Bologna, Emilia-Romagna, Italy
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia, Genova, Liguria, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
Azienda Ospedaliera di Padova, Padova, Veneto, Italy
UMC St Radboud, Nijmegen, , Netherlands
Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology, Rotterdam, , Netherlands
Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii, Warsaw, , Poland
Hospital Sant Joan De Deu, Esplugues De Llobregas, Barcelona, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus, Göteborg, , Sweden
Universitetssjukhuset Linköping; Barn och Ungdomskliniken, Linkoeping, , Sweden
Skånes Universitetssjukhus, Lund, , Sweden
Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen, Solna, , Sweden
Birmingham Childrens Hospital; Oncology Dept, Birmingham, , United Kingdom
Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT, Bristol, , United Kingdom
Addenbrookes Hospital; Paediatric Oncology Ward C2, Cambridge, , United Kingdom
Royal Hospital for Sick Children, Edinburgh, , United Kingdom
Leeds General Infirmary; Ward 35, Leeds, , United Kingdom
Alder Hey Children's NHS Foundation Trust, Liverpool, , United Kingdom
University College London NHS Foundation Trust, London, , United Kingdom
Great Ormond Street Hospital; Dept. Of Pediatric Oncology, London, , United Kingdom
Royal Manchester Childrens Hospital, Manchester, , United Kingdom
Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, , United Kingdom
Queens Medical Centre, Nottingham, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Royal Marsden Hospital; Pediatric Unit, Surrey, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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