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

Phase 1

• Conditions: Diffuse Intrinsic Pontine Glioma
• Interventions: Biological: Autologous dendritic cells

• Registration Number: NCT02840123
• Lead Sponsor: Fundació Sant Joan de Déu

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-31
• Study Start: 2016-06
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Status Verified: 2018-02
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous dendritic cells	Autologous dendritic cells	-

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events per patient (after treatment administration	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival Progression free survival	1 year
Time to first Serious Adverse Event (SAE)(after treatment)	1 year

Trial Locations

Locations (1)

Hospital Sant Joan de Deu; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain