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

Fundació Sant Joan de Déu

Status and phase

Unknown

Phase 1

Conditions

Diffuse Intrinsic Pontine Glioma

Treatments

Biological: Autologous dendritic cells

Study type

Interventional

Funder types

Other

Identifiers

NCT02840123

FSJD-DIPG-DC

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

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)