Diffuse Intrinsic Pontine GliomaPhase 1NCT02840123
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines
A Phase 1 study testing Autologous dendritic cells in people with Diffuse Intrinsic Pontine Glioma, run by Fundació Sant Joan de Déu at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Diffuse Intrinsic Pontine Glioma
- What is being tested?
- Autologous dendritic cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2016to Mar 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Being tested
- Autologous dendritic cells
- Medical subject headings
- Diffuse Intrinsic Pontine Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous dendritic cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Autologous dendritic cells | Experimental | Not described Receives: Biological: Autologous dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events per patient (after treatment administration
Measured: 2 years
Secondary outcomes (2)
Overall survival Progression free survival
Measured: 1 year
Time to first Serious Adverse Event (SAE)(after treatment)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Intrinsic Pontine GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840123
- Sponsor's protocol ID
- FSJD-DIPG-DC
- Status last verified
- Feb 2018
- First submitted
- 31 May 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02840123
- Acronym / sponsor ID
- FSJD-DIPG-DC
- Conditions
- Diffuse Intrinsic Pontine Glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Institut d'Investigacions Biomèdiques August Pi i Sunyer
- Study start
- Jun 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous dendritic cells | Experimental | Biological: Autologous dendritic cells |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous dendritic cells | Biological | Autologous dendritic cells |
Primary outcome
Number of serious adverse events per patient (after treatment administration
Time frame: 2 years
2 secondary outcomes
Overall survival Progression free survival
Time frame: 1 year
Time to first Serious Adverse Event (SAE)(after treatment)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous dendritic cells in people with Diffuse Intrinsic Pontine Glioma, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events per patient (after treatment administration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.