High Grade Glioma Clinical Trial
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
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.
n/a
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