- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02840123
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Barcelona
-
Esplugues de Llobregat, Barcelona, Spain, 08950
- Hospital Sant Joan de Déu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous dendritic cells
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of serious adverse events per patient (after treatment administration
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival Progression free survival
Time Frame: 1 year
|
1 year
|
Time to first Serious Adverse Event (SAE)(after treatment)
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Brain Stem Neoplasms
- Infratentorial Neoplasms
- Glioma
- Diffuse Intrinsic Pontine Glioma
Other Study ID Numbers
- FSJD-DIPG-DC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diffuse Intrinsic Pontine Glioma
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National Cancer Institute (NCI)RecruitingRecurrent Malignant Glioma | Recurrent Medulloblastoma | Refractory Malignant Glioma | Refractory Medulloblastoma | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Primary Central Nervous System Neoplasm | Refractory Primary Central Nervous System Neoplasm | Refractory Diffuse Intrinsic Pontine...United States, Canada
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University of California, San FranciscoTranslational Genomics Research InstituteCompletedDiffuse Intrinsic Pontine Glioma (DIPG)United States
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University of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS); The Chad-Tough... and other collaboratorsRecruitingDiffuse Intrinsic Pontine Glioma | Diffuse Midline Glioma, H3 K27M-Mutant | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Diffuse Midline Glioma, H3 K27M-Mutant | Recurrent WHO Grade III Glioma | WHO Grade III GliomaUnited States, Israel, Australia, Netherlands, Switzerland, New Zealand
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Sidney Kimmel Comprehensive Cancer Center at Johns...Solving Kids' CancerCompletedDiffuse Intrinsic Pontine Glioma (DIPG)United States
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Pediatric Brain Tumor ConsortiumNational Cancer Institute (NCI)CompletedMalignant Glioma | Recurrent Childhood Ependymoma | Recurrent Medulloblastoma | Recurrent Diffuse Intrinsic Pontine Glioma | Recurrent Atypical Teratoid/Rhabdoid Tumor | Refractory Diffuse Intrinsic Pontine Glioma | CNS Embryonal Tumor, Not Otherwise SpecifiedUnited States
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