Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
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)
1 other identifier
interventional
10
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
July 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 2, 2018
February 1, 2018
2.7 years
May 31, 2016
March 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of serious adverse events per patient (after treatment administration
2 years
Secondary Outcomes (2)
Overall survival Progression free survival
1 year
Time to first Serious Adverse Event (SAE)(after treatment)
1 year
Study Arms (1)
Autologous dendritic cells
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, 08950, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
July 21, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
March 2, 2018
Record last verified: 2018-02