Immunomonitoring in neuroblastoma patients
- Conditions
- euroblastoom, immuuntherapie, farmacokinetiek van dinutuximabNeuroblastoma, immunotherapy, pharmacokinetics of dinutuximab
- Registration Number
- NL-OMON24604
- Lead Sponsor
- Prinses Máxima Centrum
- Brief Summary
El Amrani M, Szanto CL, Hack CE, Huitema ADR, Nierkens S, van Maarseveen EM.Quantification of total dinutuximab concentrations in neuroblastoma patients with liquid chromatography tandem mass spectrometry. Anal Bioanal Chem. 2018;1–10
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
* Signed informed consent
* Newly diagnosed NBL, histologically proven diagnosis
Exclusion Criteria
* Incomplete informed consent
* Pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br><br /><br /><br>1.Regulatory T-cells<br /><br>2.Natural Killer cells<br /><br>3.Effector/memory T-cells<br /><br>4.Thelper-cells<br /><br>5.B-cells<br /><br>6.Dendritic cells<br /><br>7.Myeloid derived suppressor cells <br>
- Secondary Outcome Measures
Name Time Method The secondary objectives are the following:<br /><br>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.<br /><br>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). <br /><br>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. <br>