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

NCT ID: NCT02840123

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Diffuse Intrinsic Pontine Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Autologous dendritic cells

Group Type EXPERIMENTAL

Autologous dendritic cells

Intervention Type BIOLOGICAL

Interventions

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Autologous dendritic cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut d'Investigacions Biomèdiques August Pi i Sunyer

OTHER

Sponsor Role collaborator

Fundació Sant Joan de Déu

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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FSJD-DIPG-DC

Identifier Type: -

Identifier Source: org_study_id

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