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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Fundació Sant Joan de Déu
Sponsor:
Collaborator:
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Information provided by (Responsible Party):
Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier:
NCT02840123
First received: May 31, 2016
Last updated: August 2, 2016
Last verified: July 2016
  Purpose

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 Intervention Phase
Diffuse Intrinsic Pontine Glioma
Biological: Autologous dendritic cells
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Fundació Sant Joan de Déu:

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

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

Estimated Enrollment: 10
Study Start Date: June 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous dendritic cells Biological: Autologous dendritic cells

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02840123

Contacts
Contact: Andrés Morales La Madrid, MD +34932804000 amorales@sjdhospitalbarcelona.org

Locations
Spain
Hospital Sant Joan de Deu Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Contact: Andrés Morales La Madrid, MD    +34932804000    amorales@sjdhospitalbarcelona.org   
Contact: Ofelia Cruz, MD    +34932804000    Ocruz@sjdhospitalbarcelona.org   
Principal Investigator: Morales LaMadrid Andres, MD         
Sponsors and Collaborators
Fundació Sant Joan de Déu
Institut d'Investigacions Biomèdiques August Pi i Sunyer
  More Information

Responsible Party: Fundació Sant Joan de Déu
ClinicalTrials.gov Identifier: NCT02840123     History of Changes
Other Study ID Numbers: FSJD-DIPG-DC
Study First Received: May 31, 2016
Last Updated: August 2, 2016

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 22, 2017