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    Clinical Trial Results:
    Vascular Targeted Photodynamic therapy with WST11 for T1a Renal Tumours. PHASE IIa histological follow up trial

    Summary
    EudraCT number
    2011-003311-27
    Trial protocol
    GB  
    Global end of trial date
    11 Feb 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Feb 2019
    First version publication date
    15 Feb 2019
    Other versions
    Summary report(s)
    VTPfinalreport

    Trial information

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    Trial identification
    Sponsor protocol code
    CLIN1102KCM201
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Old Road, Oxford, United Kingdom,
    Public contact
    Tom Leslie, Nuffield Department of Surgical Sciences, University of Oxford, tom.leslie@nds.ox.ac.uk
    Scientific contact
    Tom Leslie, Nuffield Department of Surgical Sciences, University of Oxford, tom.leslie@nds.ox.ac.uk
    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
    22 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate efficacy of VTP treatment as assessed by histology in T1a Renal Tumours
    Protection of trial subjects
    General anaesthetic given for procedure to prevent pain and post-operative pain relief as required. Eye protection immediately post treatment to prevent eye problems in natural light.
    Background therapy
    None
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Jun 2012
    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
    United Kingdom: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Screening details included a history and clinical examination, performed by a trial enrolled doctor. The Trial nurse went through inclusion and exclusion criteria. Blood tests including a full blood count, urea and electrolytes and liver function tests were performed together with an electrocardiogram. CT or MRI showing a renal mass was confirmed

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

    Arms
    Arm title
    single arm
    Arm description
    Treatment of renal tumour with WST11
    Arm type
    Experimental

    Investigational medicinal product name
    WST11
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Prepared infusion. Dosage given as 2mgs/kg or 4mgs/kg as per trial protocol. Single dosage

    Number of subjects in period 1
    single arm
    Started
    5
    Completed
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    5 5
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    2 2
        From 65-84 years
    3 3
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    2 2

    End points

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    End points reporting groups
    Reporting group title
    single arm
    Reporting group description
    Treatment of renal tumour with WST11

    Primary: Extent of necrosis in renal tumour histologically

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    End point title
    Extent of necrosis in renal tumour histologically [1]
    End point description
    The end point used was to assess tumour cell death caused by the trial treatment
    End point type
    Primary
    End point timeframe
    Necrosis was measured histologically in the surgical specimen (partial or radical nephrectomy) which was performed approximately 4 weeks following the VTP treatment
    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: Histological analysis based on microscopic assessment, n = 5 and unable to do any meaningful statistical analysis on this
    End point values
    single arm
    Number of subjects analysed
    5
    Units: percentage necrosis in whole tumour
    number (not applicable)
        Percentage necrosis in tumour following treatment
    27.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From VTP treatment until 18 months post VTP treatment
    Adverse event reporting additional description
    Collected as per CTCAE definition. Cases assessed on day 1,2 and 12 following the VTP treatment. Further assessment was made based on individual adverse events and included 1 referral to an Opthalmologist regarding eye symptoms, follow up of a urine leak radiologically and a completion nephrectomy.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.03
    Reporting groups
    Reporting group title
    APTIV
    Reporting group description
    -

    Serious adverse events
    APTIV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Surgical and medical procedures
    Surgical failure
    Additional description: Unable to locate tumour correctly following VTP treatment. Initial attempt at partial nephrectomy based on apparently ablated tissue but normal tissue excised and second operation to remove whole kidney required to excise tumour
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    APTIV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    Surgical and medical procedures
    Urine leak
    Additional description: I case leaked urine following the partial nephrectomy. This is a recognised complication of a standard partial nephrectomy but it is not clear if the ablation may have increased the risk of this
         subjects affected / exposed
    1 / 5 (20.00%)
         occurrences all number
    1
    Eye disorders
    blurred vision and irritated eyes
    Additional description: Both settled spontaneously though Opthalmology opinion requested for eye irritation
         subjects affected / exposed
    2 / 5 (40.00%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2015
    The recruitment period was extended by 12 months. The number of cases to recruit was reduced from 12 to 8 and the lower age threshold for recruitment was reduced from 60 to 50

    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.
    Early termination due to slow recruitment. leading to a smaller number than intended subjects for analysis together with the inability of MRI scanning post treatment to demonstrate the ablation zone
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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