Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines

Fundació Sant Joan de Déu10 enrolled

Overview

The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Newly diagnosed DIPG Patients without progressive disease * Aged between 3 and 18 yo Lansky scale \>50 (Karnofsky for patients aged more than 16 yr) * Life expectancy \> 8 weeks * Preserved bone marrow function Normal hepatic and renal function Exclusion Criteria: * Impossibility to perform aphaeresis * Patient participation 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 dexamethasone treatment Corticoid-dependent patients * Patients under uncontrolled infection * Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)

Outcomes

Primary Outcomes

Number of serious adverse events per patient (after treatment administration

Time frame: 2 years

Secondary Outcomes

Overall survival Progression free survival

Time frame: 1 year

Time to first Serious Adverse Event (SAE)(after treatment)