Childhood aggressive gliomas are rare brain tumors with very poor prognosis. Due to the tumor's location and infiltrative nature, surgical removal is not always possible, and even when resection is performed and combined with chemo- and/or radiotherapy, tumor cells frequently persist, eventually giving rise to tumor recurrence. A promising strategy to eradicate persisting tumor cells is vaccination with dendritic cells (DC). DC are immune cells that play an important role in organizing the body's defense against cancer. The goal of DC vaccination is to activate these natural anti-tumor defense mechanisms to delay or prevent tumor progression or recurrence. Previous clinical studies have demonstrated that DC vaccination is well-tolerated, safe and capable of eliciting tumorspecific immunity. A clinical study including 10 pediatric patients (aged ≥ 12 months and \< 18 years at the time of signing the informed consent) with brain (stem) tumors is initiated at the Antwerp University Hospital to investigate intradermal vaccination with WT1 mRNA-loaded autologous monocyte-derived DCs, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies. The general objective of this phase I/II clinical study is (1) to demonstrate that WT1-targeted DC vaccine production and administration in pediatric patients with HGG and DIPG, either combined with first-line chemoradiation treatment or administered as adjuvant therapy following previous therapies, is feasible and safe, (2) to study vaccine-induced immune responses, (3) to document patients' quality of life and clinical outcome for comparison with current patients' outcome allowing indication of the added value.
Age range
12 Months – 17 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Feasibility of leukapheresis in pediatric patients with HGG and DIPG
Timeframe: Vaccine production and quality testing (i.e. from leukapheresis until 4 weeks after)
Feasibility of WT1-targeted DC vaccine production
Timeframe: Vaccine production and quality testing (i.e. from leukapheresis until 4 weeks after)
Feasibility of DC vaccine administration in pediatric patients with HGG and DIPG (administration of 1st vaccine)
Timeframe: At the administration of the 1st vaccine (i.e. +- 2 months after leukapheresis)
Feasibility of DC vaccine administration in pediatric patients with HGG and DIPG according to the study treatment schedule
Timeframe: Study treatment scheme (i.e. from leukapheresis to administration of the 9th vaccine, +- 34 weeks)
Safety of DC vaccine administration in pediatric patients with HGG and DIPG: Related (Severe) Adverse Events ((S)AEs)
Timeframe: over the entire study duration (i.e. from inclusion to end of follow-up, which lasts until 90 days after the last DC vaccine, or 24 months after inclusion, whichever occurs later)
Safety of DC vaccine administration in pediatric patients with HGG and DIPG: total (S)AEs (number)
Timeframe: over the entire study duration (i.e. from inclusion to end of follow-up, which lasts until 90 days after the last DC vaccine, or 24 months after inclusion, whichever occurs later)
Safety of DC vaccine administration in pediatric patients with HGG and DIPG: total (S)AEs (grade)
Timeframe: over the entire study duration (i.e. from inclusion to end of follow-up, which lasts until 90 days after the last DC vaccine, or 24 months after inclusion, whichever occurs later)