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    Clinical Trial Results:
    Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults

    Summary
    EudraCT number
    		 2013-003632-71
    Trial protocol
    		 ES  
    Global end of trial date
    03 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2021
    First version publication date
    03 Nov 2021
    Other versions
    Summary report(s)
    		 Final report summary

    Trial information

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    Trial identification
    Sponsor protocol code
    DEND/TIA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Clínica Universidad de Navarra
    Sponsor organisation address
    Avda. Pío XII, 36, Pamplona, Spain, 31008
    Public contact
    UCEC, Clínica Universidad de Navarra, 34 948255 4001142, ucicec@unav.es
    Scientific contact
    UCEC, Clínica Universidad de Navarra, 34 948255 4001142, ucicec@unav.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Apr 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the safety of the proposed treatment in terms of: - Effects attributable to the generation and administration of dendritic cells - Adverse effects during treatment - Autoimmunity
    Protection of trial subjects
    - Clinical trial supervised by the CEIm of Navarra - In accordance with the GCP guidelines - Patient confidentiality will be safeguarded in accordance with current legislation
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    01 Jul 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 6
    Worldwide total number of subjects
    6
    EEA total number of subjects
    6
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    1
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were selected in the Pediatric and Neurosurgery consultations of the Clínica Universidad de Navarra. Patients were recruited between 09-30-14 (first patient) and 10-30-17 (last patient). Screening failures were two patients with CNS tumors that turned out to be low grade, the exclusion criterion set by the trial.

    Pre-assignment
    Screening details
    		 NA

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dendritic cell-based
    Investigational medicinal product code
    09-033
    Other name
    AUTOLOGOUS DENDRITIC CELLS DERIVED FROM MONOCYTES CHARGED WITH AUTOLOGOUS TUMOR LISTING
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    The cells are administered in suspension, at doses between 5x106 and 10x106, of administration repeated intradermal or intranodal.

    Number of subjects in period 1
    		Treatment
    Started
    6
    Completed
    6

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy.

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    percentage of AE and relationship with treatment
    End point type
    Primary
    End point timeframe
    4 years.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As indicated in the protocol: The main variable of the study is the evaluation of safety. A descriptive analysis of the adverse events observed during the study will be carried out, both in global frequency and per patient, as well as changes in cell populations.
    End point values
    		 Treatment
    Number of subjects analysed
    6
    Units: Percentage
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 years
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 The time of administration of the vaccines is different for each type of tumor. After surgery, treatment for advanced sarcomas includes cycles of chemotherapy every three weeks (x6) that are given concomitantly with vaccines. The administration of vaccines includes 4 vaccines every three weeks 4 vaccines every two months and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy. For CNS tumors, after surgery, treatment consists of radiation therapy plus chemotherapy. Chemotherapy cycles will be given every 3 weeks (x5). The administration of the vaccines includes 4 vaccines every three weeks, 4 vaccines every two months, and 4 vaccines every three months. The rest of the vaccines are given without chemotherapy.

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
         number of deaths (all causes)
    5
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    General disorders and administration site conditions
    general discomfort
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Fever
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    induration and redness
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    5
    headache
         subjects affected / exposed
    3 / 6 (50.00%)
         occurrences all number
    3
    odynophagia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    cough
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    low-grade fever
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    paresthesia
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    immobility on right foot
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Itchy throat
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Cold
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    pulpitis
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Social circumstances
    short-term memory failure
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    anxiety
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    abdominal pain
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    2
    Vomits
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    upper respiratory infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    paronychia
         subjects affected / exposed
    2 / 6 (33.33%)
         occurrences all number
    2
    wart infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    chafing
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    ingrown toenail
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    pruritus
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1
    toe infection
         subjects affected / exposed
    1 / 6 (16.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    NA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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