Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

August 1, 2021

Study Completion Date

February 28, 2026

Conditions
Neuroblastoma
Interventions
DRUG

Bevacizumab

10mg/kg IV (in the vein) on Days 1 and 15 of a 4 week cycle, for 6 cycles or until progression

DRUG

Temozolomide

200mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression

DRUG

Temozolomide

100mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 3 week cycle, for 6 cycles or until progression

DRUG

Irinotecan

50mg/m2/d IV (in the vein) on Days 1 to 5 of a 3 week cycle, for 6 cycles or until progression

DRUG

Bevacizumab

15mg/kg IV (in the vein) on Day 1 of a 3 week cycle, for 6 cycles or until progression

DRUG

Topotecan

0.75mg/m2/d IV (in the vein) on Days 1-5 of a 4 week cycle, for 6 cycles or until progression

DRUG

Temozolomide

150mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression

DRUG

Dinutuximab Beta

10mg/m2/d IV (in the vein) on Days 1 to 7 of a 4 week cycle, for 6 cycles or until progression

DRUG

Cyclophosphamide

250mg/m2/d IV (in the vein) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression

Trial Locations (10)

3008

Swiss Paediatric Oncology Group, Bern

31059

Hopital des Enfants, Toulouse

46026

Instituto de Investigacion Sanitaria, Valencia

A-1090

St Anna Children's Hospital and CCRI/Studies and Statistics, Vienna

Unknown

University Hospital, Ghent

Natasha van Eijkelenburg, Utrecht

DK-2100

University Hospital Rigshospitalet, Copenhagen

Dublin 12

Our Ladys Children's Hospital Dublin, Dublin

00165

Ospedale Pediatrico Bambino Gseu, Rome

SM2 5PT

The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, Sutton

Sponsors
All Listed Sponsors
collaborator

Cancer Research UK

OTHER

collaborator

Roche Pharma AG

INDUSTRY

collaborator

Imagine for Margo

UNKNOWN

collaborator

EUSA Pharma, Inc.

INDUSTRY

lead

University of Birmingham

OTHER