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

Diffuse Intrinsic Pontine Glioma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02840123
• Other study ID #: FSJD-DIPG-DC
• Status: Active, not recruiting
• Phase: Phase 1
• First received: May 31, 2016
• Last updated: March 1, 2018
• Start date: June 2016
• Est. completion date: March 2019

Study information

• Verified date: February 2018
• Source: Fundació Sant Joan de Déu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diffuse Intrinsic Pontine Glioma
• Glioma

Intervention

Biological:
• Autologous dendritic cells

Locations

Country	Name	City	State
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Sant Joan de Déu	Institut d'Investigacions Biomèdiques August Pi i Sunyer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious adverse events per patient (after treatment administration		2 years
Secondary	Overall survival Progression free survival		1 year
Secondary	Time to first Serious Adverse Event (SAE)(after treatment)		1 year