No registrations found.
ID
Source
Brief title
Health condition
Neuroblastoom, immuuntherapie, farmacokinetiek van dinutuximab
Neuroblastoma, immunotherapy, pharmacokinetics of dinutuximab
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Study design
Not applicable
Intervention
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 the treatment (spread over 1.5 years)
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
* Incomplete informed consent
* Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7362 |
| NTR-old | NTR7571 |
| CCMO | NL66764.078.18 |
| OMON | NL-OMON52494 |