Neuroblastoom, immuuntherapie, farmacokinetiek van dinutuximab Neuroblastoma, immunotherapy, pharmacokinetics of dinutuximab
Conditions
Interventions
In this study there are no interventions. We will collect extra blood (5 ml) one time (for low risk and medium risk neuroblastoma patients) or 18 times (for high risk neuroblastoma patients) during th
Sponsors
Prinses Máxima Centrum
Eligibility
Inclusion criteria
Inclusion criteria: * Signed informed consent * Newly diagnosed NBL, histologically proven diagnosis * Initial staging of the tumor * Between 1-18 years old at diagnosis
Exclusion criteria
Exclusion criteria: * Incomplete informed consent * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to gain data on the different responses of the immune system between patients during (immune)therapy by exploring the presence, phenotype and function of multiple immune cell subsets in peripheral blood: 1.Regulatory T-cells 2.Natural Killer cells 3.Effector/memory T-cells 4.Thelper-cells 5.B-cells 6.Dendritic cells 7.Myeloid derived suppressor cells | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are the following: 1. If possible, we will compare immune status of patients with progressive or relapsed disease, with patients that remained disease-free throughout and following the completing of therapy. 2. Explore the variation in CH14.18 levels between patients and between treatment cycles and validate the current detection method (via liquid chromatography tandem-mass spectrometry). 3. We will study the PK and pharmacodynamics properties of CH14.18 (and GM-CSF and IL-2) in NBL patients and if applicable relate exposure parameters to efficacy and toxicity. | — |
Outcome results
None listed