Diffuse intrinsic pontine glioma (DIPG) MedDRA version: 19.0 Level: PT Classification code 10006143 Term: Brain stem glioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Cél. dendríticas dif. adultas autólogas de sangre perif. expand. cargadas con lisado de lín. tumoral
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Células dendríticas
Sponsors
Fundació Sant Joan de Déu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Newly diagnosed DIPG Patients without progressive disease Aged between 3 and 18 yo Lansky scale >50 (Karnosfsky for patients aged more than 16 yr) Life expectancy > 8 weeks Preserved bone marrow function Normal hepatic and renal function Are the trial subjects under 18? yes Number of subjects for this age range: 10 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Impossibility to perform aphaeresis Patient part of other experimental study within the last 3 months Patient under antitumor treatment in the last 4 weeks Co-morbidity that does not allow the study treatment Patients requiring > 2mg/day of dexametasone treatment Corticoid-dependent patients Patients under uncontrolled infection Positive serologies of HIV, HCV or HBV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluate the nonspecific immune response generated in peripheral blood and CSF by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation;Main Objective: To assess the safety of a first in human administration of DCs vaccination pulsed with tumor lysate from a pool of eight K27M positive DIPG cell lines;Primary end point(s): Number of serious adverse events per patient (after treatment administration);Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival Progression free survival Time to first SAE (after treatment) Immunologic parameters Changes in radiological images Relationship between immunological response and clinical response Relationship between histological, and molecular characterization, and clinical and cellular response generated by vaccination Safety parameters evaluation Performance;Timepoint(s) of evaluation of this end point: 1 year | — |
Countries
Spain
Contacts
Public ContactCTU CLINIC
Clinical Trial Unit Hospital Clínic Barcelona
Outcome results
None listed