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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

Tracking Information
First Submitted Date  ICMJE May 31, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date March 2, 2018
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
Number of serious adverse events per patient (after treatment administration [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Overall survival Progression free survival [ Time Frame: 1 year ]
  • Time to first Serious Adverse Event (SAE)(after treatment) [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diffuse Intrinsic Pontine Glioma
Intervention  ICMJE Biological: Autologous dendritic cells
Study Arms  ICMJE Experimental: Autologous dendritic cells
Intervention: Biological: Autologous dendritic cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 20, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840123
Other Study ID Numbers  ICMJE FSJD-DIPG-DC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Sant Joan de Déu
Study Sponsor  ICMJE Fundació Sant Joan de Déu
Collaborators  ICMJE Institut d'Investigacions Biomèdiques August Pi i Sunyer
Investigators  ICMJE Not Provided
PRS Account Fundació Sant Joan de Déu
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP