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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840123
Recruitment Status : Unknown
Verified February 2018 by Fundació Sant Joan de Déu.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

Study Description
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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


Condition or disease Intervention/treatment Phase
Diffuse Intrinsic Pontine Glioma Biological: Autologous dendritic cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous dendritic cells Biological: Autologous dendritic cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of serious adverse events per patient (after treatment administration [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Overall survival Progression free survival [ Time Frame: 1 year ]
  2. Time to first Serious Adverse Event (SAE)(after treatment) [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840123


Locations
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Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain, 08950
Sponsors and Collaborators
Fundació Sant Joan de Déu
Institut d'Investigacions Biomèdiques August Pi i Sunyer
More Information
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Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT02840123    
Other Study ID Numbers: FSJD-DIPG-DC
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Glioma
Diffuse Intrinsic Pontine Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Brain Stem Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases