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

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

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.

Study Overview

• Status: Completed
• Conditions: High Grade Glioma
• Intervention / Treatment: Drug: Bevacizumab; Drug: Temozolomide (TMZ); Radiation: Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • The Children's Hospital at Westmead
  • Queensland
    • South Brisbane, Queensland, Australia, QLD 4101
      • Lady Cilento Children's Hospital; Oncology Services Group, Level 12b
• Austria
  • Linz, Austria, 4020
    • Kepler Universitätskliniken GmbH - Med Campus IV.
  • Wien, Austria, 1090
    • Medizinische Universität Wien
• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven Gasthuisberg
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 6A8
      • Alberta Children's Hospital
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Hospital for Sick Children
• Czechia
  • Brno, Czechia, 62500
    • Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice
  • Prague, Czechia, 15060
    • Fakultni Nemocnice V Motole, S.P.
• Denmark
  • Aarhus N, Denmark, 8200
    • Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A
  • København Ø, Denmark, 2100
    • Rigshospitalet; Onkologisk Klinik
• France
  • Angers, France, 49033
    • Centre Hospitalier d'Angers; Service de cancérologie pédiatrique
  • Clermont Ferrand, France, 63003
    • CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP)
  • Lille, France, 59020
    • Centre Oscar Lambret; Service de Pediatrie
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille, France, 13385
    • Hopital Timone Enfants; Onco Pediatrie
  • Nice, France, 06200
    • Hopital Lenval; Service Hématologie Infantile
  • Paris, France, 75248
    • Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique
  • Rennes, France, 35056
    • CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique
  • St Priest En Jarez, France, 42777
    • Hopital Nord;Consult Pediatrie
  • Strasbourg, France, 67200
    • Hôpital Hautepierre
  • Toulouse, France, 31059
    • Hopital Des Enfants; Service d Hemato-Oncologie
  • Tours, France, 37044
    • CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie
  • Vandoeuvre-les-Nancy cedex, France, 54511
    • Hôpital Brabois Enfants
  • Villejuif, France, 94805
    • Institut Gustave Roussy; Service Pediatrique
• Hungary
  • Budapest, Hungary, 1094
    • Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit
• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh
  • Liguria
    • Genova, Liguria, Italy, 16147
      • Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedaliera di Padova
• Netherlands
  • Nijmegen, Netherlands, 6525 GA
    • UMC St Radboud
  • Rotterdam, Netherlands, 3015 GJ
    • Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology
• Poland
  • Warsaw, Poland, 04-746
    • Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Valencia, Spain, 46014
    • Hospital Universitario La Fe
  • Barcelona
    • Esplugues De Llobregas, Barcelona, Spain, 08950
      • Hospital Sant Joan de Déu
• Sweden
  • Göteborg, Sweden, 416 85
    • Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus
  • Linkoeping, Sweden, 581 85
    • Universitetssjukhuset Linköping; Barn och Ungdomskliniken
  • Lund, Sweden, 221 85
    • Skånes universitetssjukhus
  • Solna, Sweden, 171 76
    • Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Childrens Hospital; Oncology Dept
  • Bristol, United Kingdom, BS2 8BJ
    • Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrookes Hospital; Paediatric Oncology Ward C2
  • Edinburgh, United Kingdom, EH91LF
    • Royal Hospital for Sick Children
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary; Ward 35
  • Liverpool, United Kingdom, L12 2AP
    • Alder Hey Children's NHS Foundation Trust
  • London, United Kingdom, NW1 2PG
    • University College London NHS Foundation Trust
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital; Dept. Of Pediatric Oncology
  • Manchester, United Kingdom, M13 9WL
    • Royal Manchester Childrens Hospital
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Nottingham, United Kingdom, NG7 2UH
    • Queens Medical Centre
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Surrey, United Kingdom, SM2 5PT
    • Royal Marsden Hospital; Pediatric Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria - Main cohort :

• Paediatric participants, aged >= 3 years and < 18 years
• Written informed consent obtained from the participant/parents or legally acceptable representative
• Newly diagnosed localised, supratentorial or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
• Local histological diagnosis confirmed by a designated central reference neuropathologist
• Availability of the baseline magnetic resonance imaging (MRI) performed according to imaging guidelines
• Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
• Adequate bone marrow, coagulation, liver, and renal function

Young Participant Cohort

• Written informed consent obtained from parents or legal representative
• Age at enrollment: from >= 6 months to < 3 years of age
• Progressive or relapsed metastatic or localised, supra- or infratentorial, non-brain stem WHO Grade III or IV glioma (local pathology confirmation made either at initial diagnosis or at relapse)
• Availability of a baseline MRI performed according to imaging guidelines
• Adequate organ function (bone marrow, coagulation, liver, kidney)

Exclusion Criteria - Main cohort:

• Metastatic HGG defined as evidence of neuraxis dissemination by MRI or positive cerebrospinal fluid (CSF) cytology
• WHO-defined Gliomatosis cerebri (multifocal HGG)
• 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
• Radiological evidence of surgically related intracranial bleeding
• Prior diagnosis of a malignancy and disease-free for 5 years
• Prior systemic anti-cancer therapy
• Previous cranial irradiation

Young Participant Cohort

• WHO-defined Gliomatosis cerebri (multifocal HGG)
• Newly diagnosed HGG below the age of 3 years
• Relapsed HGG below the age of 6 months or above the age of 3 years regardless of the age at first onset
• Indication for concomitant cranial irradiation, regardless of age
• Any disease or condition that contraindicates the use of the study medication/treatment or places the child at an unacceptable risk of experiencing treatment-related complications
• Any specific contraindication to MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bevacizumab + TMZ Young Patient Cohort (YPC); Participants aged greater than or equal to (>/=) 6 months and less than (<) 3 years will receive 10 milligrams per kilogram (mg/kg) Bevacizumab every 2 weeks and 150 to 200 milligrams per meter squared (mg/m^2) of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.	Drug: Bevacizumab; 10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days; Other Names: Avastin; 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.
Experimental: Main Cohort: Chemoradiation + Bevacizumab + TMZ; Participants will receive a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab will be given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.	Drug: Bevacizumab; 10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days; Other Names: Avastin; 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.; 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.
Active Comparator: Main Cohort: Chemoradiation + TMZ; Participants will receive a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)	EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.	From the time of randomization to the date of any defined event (up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method.	From the time of randomization to the date of death (up to approximately 60 months)
Percentage of Participants With 1-Year Survival	1-year survival was estimated using the Kaplan-Meier method.	1 year after end of treatment
Percentage of Participants With EFS as Determined by the CRRC at 6 Months	EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.	6 months
Percentage of Participants With EFS as Determined by the CRRC at 1 Year	EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.	1 year
EFS as Assessed by the Investigator	EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or >/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.	From the time of randomization to the date of any defined event (up to 12 months)
Objective Response Rate (ORR)	ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions >/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: ≥ 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline.	From the time of randomization to the date of any defined event (up to 12 months)
Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival	Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion.	Up to 12 months
Health Status as Measured by the Health Utility Index (HUI)	HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older.	Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up)
Neurological Psychological Function as Measured by the Wechsler Scale	The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability.	End of treatment (approximately 58 weeks post-baseline)
Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations		From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)
Percentage of Participants With a Treatment Delay or Discontinuation		From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)
Number of Radiotherapy Dose Administrations in the Concurrent Phase	Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.	Beginning of the concurrent phase to end of treatment break (10 weeks)
Number of Dose Administrations of TMZ and Bevacizumab in the Concurrent Phase	Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.	Beginning of the concurrent phase to end of treatment break (10 weeks)
Percentage of Participants With an Adverse Event (AE)	An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.	From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Rodriguez D, Calmon R, Aliaga ES, Warren D, Warmuth-Metz M, Jones C, Mackay A, Varlet P, Le Deley MC, Hargrave D, Canete A, Massimino M, Azizi AA, Saran F, Zahlmann G, Garcia J, Vassal G, Grill J, Peet A, Dineen RA, Morgan PS, Jaspan T. MRI and Molecular Characterization of Pediatric High-Grade Midline Thalamic Gliomas: The HERBY Phase II Trial. Radiology. 2022 Jul;304(1):174-182. doi: 10.1148/radiol.211464. Epub 2022 Apr 12.
• Varlet P, Le Teuff G, Le Deley MC, Giangaspero F, Haberler C, Jacques TS, Figarella-Branger D, Pietsch T, Andreiuolo F, Deroulers C, Jaspan T, Jones C, Grill J. WHO grade has no prognostic value in the pediatric high-grade glioma included in the HERBY trial. Neuro Oncol. 2020 Jan 11;22(1):116-127. doi: 10.1093/neuonc/noz142.
• Rodriguez D, Chambers T, Warmuth-Metz M, Aliaga ES, Warren D, Calmon R, Hargrave D, Garcia J, Vassal G, Grill J, Zahlmann G, Morgan PS, Jaspan T. Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas. AJNR Am J Neuroradiol. 2019 Mar;40(3):568-575. doi: 10.3174/ajnr.A5982. Epub 2019 Feb 28.
• Mackay A, Burford A, Molinari V, Jones DTW, Izquierdo E, Brouwer-Visser J, Giangaspero F, Haberler C, Pietsch T, Jacques TS, Figarella-Branger D, Rodriguez D, Morgan PS, Raman P, Waanders AJ, Resnick AC, Massimino M, Garre ML, Smith H, Capper D, Pfister SM, Wurdinger T, Tam R, Garcia J, Thakur MD, Vassal G, Grill J, Jaspan T, Varlet P, Jones C. Molecular, Pathological, Radiological, and Immune Profiling of Non-brainstem Pediatric High-Grade Glioma from the HERBY Phase II Randomized Trial. Cancer Cell. 2018 May 14;33(5):829-842.e5. doi: 10.1016/j.ccell.2018.04.004.
• Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Canete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. doi: 10.1200/JCO.2017.76.0611. Epub 2018 Feb 7.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2011
• Primary Completion (Actual): February 5, 2016
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 11, 2011

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Temozolomide; Bevacizumab
• Other Study ID Numbers: BO25041; 2010-022189-28 (EudraCT Number); ITCC-019 (Other Identifier: Innovative Therapies for Children with Cancer Consortium (ITCC)); HGG-01 (Other Identifier: SIOP-E-Brain Tumour Group)