de Novo GlioblastomaPhase 1DENDR-STEMNCT02820584
A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma
A Phase 1 study testing GSC-loaded autologous dendritic cells in people with de Novo Glioblastoma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
Trial summary
Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- de Novo Glioblastoma
- What is being tested?
- GSC-loaded autologous dendritic cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jun 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤70 years;
- Histological diagnosis of de novo GBM (i.e. not secondary GBM);
- Gross total resection as evaluated by MRI performed within 72 hours from surgery;
- Karnofsky Performance Status (KPS) ≥60 at the time of first progression;
- Written informed consent.
Who cannot join
- Pregnancy or breast feeding;
- Participation in other clinical trials with experimental drugs simultaneously;
- Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose;
- Presence of sub-ependymal diffusion of the tumor;
- Presence of multi-focal GBM lesion;
- Haematology: leukocytes (WBC) < 3x103/μl, absolute lymphocyte count< 0.5x103/μl, Absolute neutrophil count (ANC) < 1x103/μl, hemoglobin< 9 g/dL, platelets< 50x103/μl within two days prior to leukapheresis;
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- AST (SGOT)/ALT (SGPT) ≥3 X institutional Upper Limit Normal (ULN) at the time of leukapheresis;
- Serum creatinine>1.5 ULN or calculated creatinine clearance < 60 ml/min at time of surgery;
- Documented immune deficiency;
- Documented systemic autoimmune disease;
- Positivity for HBV, HIV, HCV, Treponema Pallidum;
- Allergies to any component of the DC vaccine;
- Other active malignancy.
About this study
Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. The primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. In particular we will investigate the effect of treatment on effector cells including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.
- Conditions
- de Novo Glioblastoma
- Being tested
- GSC-loaded autologous dendritic cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSC-loaded autologous dendritic cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| GSC-loaded autologous dendritic cells | Experimental | DC-GSC immunotherapy. Six vaccinations are envisaged. The first three vaccinations will be performed every two weeks; subsequent three vaccinations every month. The first vaccination will be performed using 20 million DC, the second and third with 10 million DC; and from the 4th vaccine 5 million DC Receives: Biological: GSC-loaded autologous dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: - incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE version 4.0; - maximum toxicity grade and percentage of patients experiencing grade 3-4 by each patient for each specific toxicity; - patients with at least a SAE.
Safety will be assessed as follows:
- Incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE, version 4.0
- Maximum toxicity grade experienced by each patient for each specific toxicity
- Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity
- Patients with at least a SAE
- Patients with at least a SADR
- Patients with at least a Suspected Unexpected Serious Associated Reaction (SUSAR).
Measured: 18 months
Incidence, severity and type of AEs throughout the study, and toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria for AE (CTCAE), version 4.0
Measured: 18 months
Secondary outcomes (6)
Probability to obtain the full vaccine dosage, i.e. the percentage of patients who will be treated with at least 2 vaccine injections.
Measured: 18 months
Immunologic activity
activity of immunotherapy in terms of its effect on immune response of predefined immune effector cells.
Measured: 18 months
Progression free survival (PFS)
Progression Free Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of second progression.
Measured: 18 months
Quality of life
Treatment effect on quality of life will be assessed using the EORTC QLQ-C30 and BN-20.
Measured: 18 months
Quality of life
Treatment effect on quality of life will be assessed using the BN-20 questionnaire.
Measured: 18 months
Overall survival (OS)
Overall Survival after immunotherapy is defined for each patient as the time of onset of immunotherapy to the date of death from any cause.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Novo GlioblastomaStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano Finocchiaro, MD, Principal investigator, Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820584
- Sponsor's protocol ID
- DENDR-STEM
- Acronym
- DENDR-STEM
- Status last verified
- Sep 2019
- First submitted
- 22 Feb 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Immunotherapy With GSC -Loaded Dendritic Cells in Patients With Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT02820584
- Acronym / sponsor ID
- DENDR-STEM / DENDR-STEM
- Conditions
- de Novo Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 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.
Mono-center, un-controlled, open label, first in human, clinical trial. Approximately 20 patients (in order to achieve 12 valuable patients). The expected accrual time would range between 12 and 18 months. Follow-up, including clinical, immune and radiological monitoring will end two years after the initial surgery of the last patient enrolled. The primary objective will be to assess the activity of immunotherapy in terms of its effect on immune response. In particular we will investigate the effect of treatment on effector cells including CD8 T cells, NK cells and Natural Killer T (NKT) cells. The sample size of 12 eligible patients was identified on ethical and practical considerations, rather than by a formal sample size calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GSC-loaded autologous dendritic cells | Experimental | Biological: GSC-loaded autologous dendritic cellsDC-GSC immunotherapy. Six vaccinations are envisaged. The first three vaccinations will be performed every two weeks; subsequent three vaccinations every month. The first vaccination will be performed using 20 million DC, the second and third with 10 million DC; and from the 4th vaccine 5 million DC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 and ≤70 years;
- Histological diagnosis of de novo GBM (i.e. not secondary GBM);
- Gross total resection as evaluated by MRI performed within 72 hours from surgery;
- Karnofsky Performance Status (KPS) ≥60 at the time of first progression;
- Written informed consent.
Key exclusion criteria (13 listed)
- Pregnancy or breast feeding;
- Participation in other clinical trials with experimental drugs simultaneously;
- Mandatory treatment with corticosteroids or salicylates in anti-inflammatory dose;
- Presence of sub-ependymal diffusion of the tumor;
- Presence of multi-focal GBM lesion;
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 |
|---|---|---|
| GSC-loaded autologous dendritic cells | Biological | GSC-loaded autologous dendritic cells |
Primary outcome
Safety: - incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE version 4.0; - maximum toxicity grade and percentage of patients experiencing grade 3-4 by each patient for each specific toxicity; - patients with at least a SAE.
Time frame: 18 months
Safety will be assessed as follows: * Incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE, version 4.0 * Maximum toxicity grade experienced by each patient for each specific toxicity * Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity * Patients with at least a SAE * Patients with at least a SADR * Patients with at least a Suspected Unexpected Serious Associated Reaction (SUSAR).
Incidence, severity and type of AEs throughout the study, and toxicities will be graded according to the National Cancer Institute Common Toxicity Criteria for AE (CTCAE), version 4.0
Time frame: 18 months
6 secondary outcomes
Probability to obtain the full vaccine dosage, i.e. the percentage of patients who will be treated with at least 2 vaccine injections.
Time frame: 18 months
Immunologic activity
Time frame: 18 months
Progression free survival (PFS)
Time frame: 18 months
Quality of life
Time frame: 18 months
Quality of life
Time frame: 18 months
Overall survival (OS)
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Individual participant dataSharing planned: No
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.
Gaetano Finocchiaro, MD principal investigator
Fondazione IRCCS Istituto Neurologico "Carlo Besta" di Milano
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSC-loaded autologous dendritic cells in people with de Novo Glioblastoma, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: - incidence, nature, severity and seriousness of AEs, according to NCI-CTCAE version 4.0; - maximum toxicity grade and percentage of patients experiencing grade 3-4 by each patient for each specific toxicity; - patients with at least a SAE. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 12 Sep 2019.