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

Primary Purpose

Diffuse Intrinsic Pontine Glioma

Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Autologous dendritic cells
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hospital Sant Joan de Deu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous dendritic cells

Arm Description

Outcomes

Primary Outcome Measures

Number of serious adverse events per patient (after treatment administration

Secondary Outcome Measures

Overall survival Progression free survival
Time to first Serious Adverse Event (SAE)(after treatment)

Full Information

First Posted
May 31, 2016
Last Updated
March 1, 2018
Sponsor
Fundació Sant Joan de Déu
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer
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1. Study Identification

Unique Protocol Identification Number
NCT02840123
Brief Title
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
Official Title
Phase Ib Clinical Trial on the Safety of Immunotherapy With Autologous Dendritic Cells Primed With Lysate Allogeneic Tumor Lines in Patients With Diffuse Intrinsic Pontine Glioma (DIPG)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Institut d'Investigacions Biomèdiques August Pi i Sunyer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Intrinsic Pontine Glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Autologous dendritic cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Autologous dendritic cells
Primary Outcome Measure Information:
Title
Number of serious adverse events per patient (after treatment administration
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall survival Progression free survival
Time Frame
1 year
Title
Time to first Serious Adverse Event (SAE)(after treatment)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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