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    Clinical Trial Results:
    Electrochemotherapy as a palliative treatment for brain metastases

    Summary
    EudraCT number
    		 2010-023356-90
    Trial protocol
    		 DK  
    Global end of trial date
    30 Jul 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2021
    First version publication date
    29 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01322100
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Julie Gehl moved to Zealand University Hospital in 2017, Herlev Hospital, 45 93577626, kgeh@regionsjaelland.dk
    Scientific contact
    Julie Gehl moved to Zealand University Hospital in 2017, Herlev Hospital, 45 93577626, kgeh@regionsjaelland.dk
    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
    30 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.
    Protection of trial subjects
    Written informed consent was mandatory for inclusion and patients were informed according to guidelines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Apr 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Place of recruitment was the Department of Oncology at Herlev Hospital.

    Pre-assignment
    Screening details
    		 Patients with brain metastases from any solid tumor cancer. Patients must have been offered all standard treatments.

    Period 1
    Period 1 title
    inclusion, treatment and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Treatment
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    15000 IU of bleomying/m2 BSA administered by infusion before delivery of electric pulses. Once only treatment.

    Number of subjects in period 1
    		Treatment
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    inclusion, treatment and follow-up
    Reporting group description
    		 -

    Reporting group values
    		 inclusion, treatment and follow-up Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 1 1
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Primary: Safety

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    End point title
    		 Safety [1]
    End point description
    Adverse events and serious adverse events were reported according to CTCAE 4.0
    End point type
    Primary
    End point timeframe
    From inclusion through treatment and follow-up period
    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: Because only one subject was included in the trial statistical analysis can not be performed.
    End point values
    		 Treatment
    Number of subjects analysed
    1
    Units: Adverse events
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion through treatment and follow-up
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Seizure
    Additional description: One incident with brief seizure in the postoperative period was recorded
         subjects affected / exposed
    1 / 1 (100.00%)
         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.
    The patient group to be included in this study were patients with brain metastases who had been offered all standard treatments. It was observed that recruitment was difficult and for this reason the trial was terminated after treatment of just 1 pt.
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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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