Safety Study of DIPG Treatment With Autologous Dendritic... | NCT02840123

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

NCT02840123

Sponsor

Fundació Sant Joan de Déu

Status

Unknown status

Last Update Posted

Mar 2, 2018Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Diffuse Intrinsic Pontine Glioma

Interventions

Autologous dendritic cells

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Mar 2019Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

May 31, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2018

Last Update Posted Date

Mar 2, 2018Actual

Name	Class
Institut d'Investigacions Biomèdiques August Pi i Sunyer	OTHER

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Autologous dendritic cells	Experimental		Biological: Autologous dendritic cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous dendritic cells	Biological		Autologous dendritic cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of serious adverse events per patient (after treatment administration		2 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival Progression free survival		1 year
Time to first Serious Adverse Event (SAE)(after treatment)		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Sant Joan de Deu		Esplugues de Llobregat	Barcelona	08950	Spain

Type	Date	Date Unknown
Release	May 15, 2024
Reset	Sep 20, 2024

Submission Tracking

Estimated Results First Submitted Date

May 15, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 15, 2024			Sep 20, 2024

Condition Browse Module

MeSH Terms

ID	Term
D000080443	Diffuse Intrinsic Pontine Glioma

Ancestor Terms

ID	Term
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided