High risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed/relapsed as high-risk neuroblastoma), which is histologically proven as per International Neuroblastoma Staging System (INSS) definition.
Conditions
Brief summary
Progression-Free Survival time (as per INRC 2017) – for Tier 1 (randomised comparison), Definition of a safe and tolerable combination regimen – for Tier 2 (dose expansion-confirmation cohorts)
Detailed description
Best objective response (complete and partial response) as per INRC 2017 during trial treatment (12 cycles), Clinical benefit (complete, partial and minor response and stable disease) as per INRC 2017., Time response to progression (for responders), Overall Survival time, Quality of life measured by Peds-QL questionnaires, Incidence and Severity of AEs
Interventions
DRUGTEMOZOLOMIDE
DRUGBEVACIZUMAB
DRUGIRINOTECAN
DRUGKimozo 40 mg/ml
DRUGTOPOTECAN
Sponsors
The University Of Birmingham
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival time (as per INRC 2017) – for Tier 1 (randomised comparison), Definition of a safe and tolerable combination regimen – for Tier 2 (dose expansion-confirmation cohorts) | — |
Secondary
| Measure | Time frame |
|---|---|
| Best objective response (complete and partial response) as per INRC 2017 during trial treatment (12 cycles), Clinical benefit (complete, partial and minor response and stable disease) as per INRC 2017., Time response to progression (for responders), Overall Survival time, Quality of life measured by Peds-QL questionnaires, Incidence and Severity of AEs | — |
Countries
Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden
Outcome results
None listed