Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children
Status:
Active, not recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate whether Bevacizumab (an anti-VEGF monoclonal
antibody) added to a backbone chemotherapy regimen (Temozolomide, Irinotecan-Temozolomide or
Topotecan-Temozolomide) demonstrates activity in children with relapsed or refractory
neuroblastoma. Also, to investigate whether the addition of Irinotecan or Topotecan to
Temozolomide increases the activity of chemotherapy.The primary objective of the study is the
best response (Complete Response or Partial Response) while trial treatment, within 18 or 24
weeks depending on the arm of the trial the participant is randomised to. Secondary endpoints
are assessing the side effects, the length of time before progression (Progression Free
Survival) and overall survival (OS).
This trial will address two important questions:
- does targeting blood vessel development using bevacizumab, (a monoclonal antibody
against the Vascular Endothelial Growth Factor (VEGF)), add to the effect on a tumour
when used with existing chemotherapy, compared to the effect of the existing
chemotherapy alone (temozolomide)? NOTE- This question has been completed.
- does the addition of a second chemotherapy drug (irinotecan or topotecan) increase the
effect on a tumour compared to the effect of one alone (temozolomide) NOTE - This
question has been completed.
- does the addition of dinutuximab beta added to a backbone chemotherapy (temozolomide or
temozolomide + topotecan) increase the effect of backbone alone.
Patients aged 1-21 years of age with relapsed or refractory high-risk neuroblastoma are
randomised to one of two treatment arms: temozolomide-topotecan (TTo) or dinutuximab
beta-temozolomide-topotecan (dBTTo). Temozolomide (T), irinotecan-temozolomide (IT),
bevacizumab-T (BT), BIT (bevacizumab-IT), bevacizumab-temozolomide-topotecan (BTTo) and
dinutuximab beta-temozolomide (dBT) are now closed to recruitment.
Phase:
Phase 2
Details
Lead Sponsor:
University of Birmingham
Collaborators:
Cancer Research UK EUSA Pharma, Inc. Imagine for Margo Roche Pharma AG