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    Clinical Trial Results:
    Calcium electroporation for the treatment of cutaneous metastases.

    Summary
    EudraCT number
    		 2012-005704-17
    Trial protocol
    		 DK  
    Global end of trial date
    23 Jan 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    AA1232
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01941901
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Oncology, University Hospital Herlev
    Sponsor organisation address
    Herlev Ringvej 75, Herlev, Denmark, 2730
    Public contact
    Department of Oncology, Herlev Hosp. In 2017 Julie Gehl changed position to Zealand Uni. Hosp., Department of Oncology, Herlev Hospital, 45 93577626, kgeh@regionsjaelland.dk
    Scientific contact
    Department of Oncology, Herlev Hosp. In 2017 Julie Gehl changed position to Zealand Uni. Hosp., Department of Oncology, 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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate tumorresponse of calcium elctroporation and eletrochemotherapy with intratumoral bleomycin on cutaneous metastases, and compare the effect of the two treatments.
    Protection of trial subjects
    Patients included had consented in writing and fulfilled all eligibility criteria. Standard safety monitoring was performed during treatment.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    2
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from one site (Herlev Hospital).

    Pre-assignment
    Screening details
    		 Patients with any solid cancer and cutaneous metastases could be screened for inclusion. Patients could recieve other treatment, and could be included if there was no sign of regression of the cutaneous metastases - or progression.

    Period 1
    Period 1 title
    inclusion, treatment and follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Carer, Assessor, Subject
    Blinding implementation details
    Patients with cutaneous metastases were included in the study. The cutaneous metastases were identified by a number and measured. The measurements of these numbered metastases were given to the pharmacy unit through a hatch. The pharmacy mixed the correct volume of either calcium og bleomycin in one syringe per identified metastasis. Treatment proceded without the subject or investigator knowing whether the injected matter was calcium or bleomycin. At 6 monhts follow up the code was revealed.

    Arms
    Arm title
    		 Treatment
    Arm description
    		 All patients were treated. Individual metastases were assigned to either calcium electroporation or electroporation with bleomycin.
    Arm type
    		 Experimental

    Investigational medicinal product name
    calcium chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intratumoral use
    Dosage and administration details
    The dose of calcium chloride was estimated from preclinical studies and set to 9 mg/ml (220 mmol/l). Initially, the injected volume for both bleomycin and calcium chloride were 0.5 ml/cm3 tumor volume. After treatment of five patients, the volume for the smaller tumors (0.5 cm3) was amended to 1 ml/cm3. Tumor volume was calculated as axbxbxpi/6, a = largest diameter, b = largest diameter perpendicular to a.

    Investigational medicinal product name
    bleomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intratumoral use
    Dosage and administration details
    The dose of bleomycin was set to 1000 IU/ml in accordance with European Standard Operating Procedures for Electrochemotherapy (ESOPE). Initially, the injected volume for both bleomycin and calcium chloride were 0.5 ml/cm3 tumor volume. After treatment of five patients, the volume for the smaller tumors (0.5 cm3) was amended to 1 ml/cm3. Tumor volume was calculated as axbxbxpi/6, a = largest diameter, b = largest diameter perpendicular to a.

    Number of subjects in period 1
    		Treatment
    Started
    7
    Completed
    7

    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
    		 7 7
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 5 5
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 All patients were treated. Individual metastases were assigned to either calcium electroporation or electroporation with bleomycin.

    Primary: Response to treatment

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    End point title
    		 Response to treatment [1]
    End point description
    This reporting system does not allow reporting results from all treated metastases (as there a 7 subjects treated, but 37 metastases evaluated), which is the primary endpoint as reported in the paper listed. This endpoint reporting then lists the number of patients who have experienced response of treated lessions in the reporting period. Response is then that one or more treated metastases have at least a partial response (reduction of lesion by 30% or more, up to compete remission), and the number listed is the amount of patients which had at least one partial or complete response in the treated lesions.
    End point type
    Primary
    End point timeframe
    6 months
    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: The endpoint of this trial is based on evaluating treatment of 37 cutaneous metases, in 7 patients that each had one or more metastases. The paper from the study describes this including statistical analysis. It was not possible to report number of metastases across patients in the EudraCT reporting system, so we had to list the patients experiencing response.
    End point values
    		 Treatment
    Number of subjects analysed
    7
    Units: patients
        Patients with objective response of metastases
    6
        Patients without objective response of metastases
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline through completion of last 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
    		 All patients were treated. Individual metastases were assigned to either calcium electroporation or electroporation with bleomycin.

    Serious adverse events
    		 Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (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
    7 / 7 (100.00%)
    Skin and subcutaneous tissue disorders
    ulceration
    Additional description: ulceration of treated cutaneous metastasis (more than one metastasis could be treated in the same patient)
         subjects affected / exposed
    4 / 7 (57.14%)
         occurrences all number
    4
    Itch
    Additional description: Itching localized to the treated cutaneous metastases
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3
    exudation
    Additional description: Exudation of the cutaneous metastasis treated (more than one metastasis can be treated in each patient).
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3
    Hyperpigmentation
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28816072
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