Treatment of children with newly diagnosed brain tumour (known as supratentorial, infratentorial cerebellar, or peduncular high-grade glioma) using bevacizumab, an anti-angiogenic drug, added to conventional therapy (surgery, chemotherapy with temozolomide and radiation therapy).

Phase 1

• Conditions: ewly diagnosed high-grade glioma; MedDRA version: 17.1Level: LLTClassification code 10030288Term: Oligodendroglioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: LLTClassification code 10002226Term: Anaplastic ependymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: LLTClassification code 10027744Term: Mixed astrocytoma-oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10030286Term: OligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10018338Term: GliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.1Level: PTClassification code 10026659Term: Malignant oligodendrogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-022189-28-HU
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-27
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

- Written informed consent obtained from the patient/parents or legally acceptable representative
- Paediatric patients, age >/=3 years and <18 years
- Newly diagnosed localized, supratentorial- or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
- Local histological diagnosis confirmed by a designated central reference neuropathologist
- Availability of a 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Metastatic (HGG) defined as evidence of neuraxis dessimination 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Event-free Survival (EFS) as assessed by the central radiology review committee;Timepoint(s) of evaluation of this end point: 12 months after last evaluable patients has been randomized;Main Objective: To determine the benefit in terms of EFS of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.;Secondary Objective: To evaluate the efficacy, safety and tolerability of the addition of bevacizumab to postoperative radiotherapy with concomitant and adjuvant TMZ.