High-grade glioma (HGG), Diffuse intrinsic pontine glioma (DIPG)
Conditions
Brief summary
Feasibility, based on the proportion of (A) patients in the intention-to-treat (ITT) population that had successful leukapheresis, (B) patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements), (C) patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine), (D) efficacy evaluable patients in the ITT population, Safety: Occurrence of AEs and SAEs during DC vaccine administration and follow-up period (A) Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to DC vaccination, (B) Number and grade of (S)AEs in the safety population
Detailed description
Indicators of clinical activity: (A) Best overall response, (B) Progression free survival, (C) Overall survival, Immunogenicity, including, but not limited to, the following measures of (anti-tumor) immune responses: (A) Functional WT1-specific T cell responses, (B) Occurrence of WT1-specific CD8+ T cells, (C) Functional WT1-specific T cell responses, Quality of life: (A) How patients experience different phases of the study treatment schedule, (B) How patient- and proxy-reported disease-related symptoms evolve over time during the study, (C) How patient- and proxy-reported general quality of life evolves over time during the study
Interventions
DRUGWT1 LAMP mRNA DC
Sponsors
Antwerp University Hospital
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, based on the proportion of (A) patients in the intention-to-treat (ITT) population that had successful leukapheresis, (B) patients in the ITT population that had successful vaccine production (i.e. production of 9 or more vaccines meeting quality control requirements), (C) patients in the ITT population who complete the study treatment schedule (i.e. from leukapheresis until administration of the 9th vaccine), (D) efficacy evaluable patients in the ITT population, Safety: Occurrence of AEs and SAEs during DC vaccine administration and follow-up period (A) Proportion of patients of the safety population that experienced (S)AEs possibly, probably or definitely related to DC vaccination, (B) Number and grade of (S)AEs in the safety population | — |
Secondary
| Measure | Time frame |
|---|---|
| Indicators of clinical activity: (A) Best overall response, (B) Progression free survival, (C) Overall survival, Immunogenicity, including, but not limited to, the following measures of (anti-tumor) immune responses: (A) Functional WT1-specific T cell responses, (B) Occurrence of WT1-specific CD8+ T cells, (C) Functional WT1-specific T cell responses, Quality of life: (A) How patients experience different phases of the study treatment schedule, (B) How patient- and proxy-reported disease-related symptoms evolve over time during the study, (C) How patient- and proxy-reported general quality of life evolves over time during the study | — |
Countries
Belgium
Outcome results
None listed