Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01390948 : A Study of Avastin (Bevacizumab) in Combination With Temolozomide (TMZ) and Radiotherapy in Paediatric and Adolescent Patients With High-Grade Glioma
PhasePhase 2
AgesMin: 6 Months Max: 18 Years
Eligibility
Inclusion Criteria:

- Paediatric patients, aged >= 3 years and < 18 years

- Written informed consent obtained from the patient/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 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, renal function

Young Patient 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 magnetic resonance imaging (MRI) performed according to
imaging guidelines

- Adequate organ function (bone marrow, coagulation, liver, kidney)

Exclusion Criteria:

- Metastatic (HGG) defined as evidence of neuraxis dissemination by MRI or positive 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 Patient Cohort

- WHO-defined Gliomatosis cerebri (multifocal high-grade glioma)

- Newly diagnosed high-grade glioma 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01390948      |      Link to official Clinicaltrials.gov listing
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