SarcomaPhase 1/2DEND/TIANCT02496520
Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
A Phase 1/2 study testing dendritic cells, Surgery as needed by the patient´s tumor and stage and Chemotherapy as needed by the patient´s tumor and stage in people with Sarcoma and Central Nervous System Tumor, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or… Read more about this study
- Who is it for?
- Ages 3 to 40 years
- Conditions the study is for
- Sarcoma, Central Nervous System Tumor
- What is being tested?
- dendritic cells, Surgery as needed by the patient´s tumor and stage and Chemotherapy as needed by the patient´s tumor and stage
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2014to 27 May 2019
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent
- Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor
- From 3 to 40 years
- Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal.
Who cannot join
- Toxicity or liver, medullar, renal insufficiency that advise against participation
- Pregnant or breast feeding women
- Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma
- Immunosuppressive treatment
- Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection
Trial locations and contacts
1 site in 1 country.
About this study
Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.
Read the detailed description
Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.
- Conditions
- Sarcoma, Central Nervous System Tumor
- Being tested
- dendritic cells, Surgery as needed by the patient´s tumor and stage, Chemotherapy as needed by the patient´s tumor and stage, Radiation therapy as needed by the patient´s tumor and stage
- Keywords
- dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy
- Medical subject headings
- Sarcoma, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cellsBiological
vaccines with dendritic cells pulsed with tumor lysate
Surgery as needed by the patient´s tumor and stageProcedure or surgery
Chemotherapy as needed by the patient´s tumor and stageDrug
Radiation therapy as needed by the patient´s tumor and stageRadiation
| Study group | Role | What they receive |
|---|---|---|
| Vaccines with autologous dendritic cells | Experimental | Vaccines with autologous dendritic cells Receives: Biological: dendritic cells; Procedure: Surgery as needed by the patient´s tumor and stage; Drug: Chemotherapy as needed by the patient´s tumor and stage; Radiation: Radiation therapy as needed by the patient´s tumor and stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of adverse events detected in the follow up as a measure of safety and tolerability
Measured: 24 months
Secondary outcomes (3)
Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy
Measured: 36 months
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.
Measured: 2 weeks to 24 months
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start30 Sep 2014
- Primary completion16 Sep 2018
- Study completion27 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Patiño-García, PhD, Principal investigator, CUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496520
- Sponsor's protocol ID
- DEND/TIA
- Other IDs
- 2013-003632-71
- Acronym
- DEND/TIA
- Status last verified
- May 2019
- First submitted
- 15 Jun 2015
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults
- ClinicalTrials.gov ID
- NCT02496520
- Acronym / sponsor ID
- DEND/TIA / DEND/TIA
- Conditions
- Sarcoma, Central Nervous System Tumor
- Keywords
- dendritic cell vaccination, sarcoma, central nervous system tumor, childhood, adolescent, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 30 Sep 2014 (actual)
- Primary completion
- 16 Sep 2018 (actual)
- Study completion
- 27 May 2019 (actual)
- First posted
- 14 Jul 2015 (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.
Phase I/II, open, prospective clinical trial, historically controlled. The objective is to evaluate the safety and, as a secondary measure, the efficacy of an experimental treatment based on a cellular therapy (vaccination with autologous dendritic cells pulsed with tumor lysate) in patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors.
Detailed description
Phase I/II, open, prospective clinical trial, historically controlled. Patients affected of metastatic or relapsed sarcomas or (Central Nervous System) CNS tumors will be included. The patients will receive standard treatment and experimental treatment based on a cellular therapy with vaccination with autologous dendritic cells pulsed with tumor lysate. The immunization schedule includes 4 monthly vaccines, 4 bimonthly and quarterly remaining vaccines. The vaccines will be administered intradermally in combination with standard treatment for each type of tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccines with autologous dendritic cells | Experimental | Biological: dendritic cells, Procedure: Surgery as needed by the patient´s tumor and stage, Drug: Chemotherapy as needed by the patient´s tumor and stage, Radiation: Radiation therapy as needed by the patient´s tumor and stageVaccines with autologous dendritic cells |
Who may qualify
- Ages
- 3 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Signed informed consent
- Diagnosis or metastatic or relapsed sarcoma or high grade central nervous system tumor
- From 3 to 40 years
- Surgery feasibility. In the central nervous system tumors, residual tumor after surgery must be minimal.
Key exclusion criteria (5 listed)
- Toxicity or liver, medullar, renal insufficiency that advise against participation
- Pregnant or breast feeding women
- Diagnosis of other tumor than basal cell squamous carcinoma of the skin or in situ cervix carcinoma
- Immunosuppressive treatment
- Human Immunodeficiency virus (HIV), hepatitis B, hepatitis C or syphilis infection
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 |
|---|---|---|
| dendritic cellsvaccines with dendritic cells pulsed with tumor lysate | Biological | Vaccines with autologous dendritic cells |
| Surgery as needed by the patient´s tumor and stage | Procedure or surgery | Vaccines with autologous dendritic cells |
| Chemotherapy as needed by the patient´s tumor and stage | Drug | Vaccines with autologous dendritic cells |
| Radiation therapy as needed by the patient´s tumor and stage | Radiation | Vaccines with autologous dendritic cells |
Primary outcome
Number and type of adverse events detected in the follow up as a measure of safety and tolerability
Time frame: 24 months
3 secondary outcomes
Event free progression, overall survival, time to progression and number and size of existent tumoral lesions as measures of clinical efficacy
Time frame: 36 months
Humoral and cellular immune response as a measure of the immunogenicity of the vaccine.
Time frame: 2 weeks to 24 months
Quality of life measured with QLQ-C30, QLQ-BN20 questionnaires.
Time frame: 36 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 21 Feb 2020.
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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.
Ana Patiño-García, PhD principal investigator
CUN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing dendritic cells, Surgery as needed by the patient´s tumor and stage and Chemotherapy as needed by the patient´s tumor and stage in people with Sarcoma and Central Nervous System Tumor, run by Clinica Universidad de Navarra, Universidad de Navarra 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 5 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 21 Feb 2020. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number and type of adverse events detected in the follow up as a measure of safety and tolerability (time frame: 24 months). 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 21 Feb 2020.