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    Clinical Trial Results:
    Irinotecan single drug treatment for children with refractory or relapsed hepatoblastoma

    Summary
    EudraCT number
    		 2005-002925-29
    Trial protocol
    		 AT  
    Global end of trial date
    31 Dec 2005

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Apr 2021
    First version publication date
    09 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    200605
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52 A, Innsbruck, Austria, 6020
    Public contact
    Ao. Univ.Prof. Dr. Bernhard Meister, Paediatrics I (hematoloy, oncoloy and stem cell transplantation) Anichstrasse 35, 6020 Innsbruck, +43 (0)512-504-23525, bernhard.meister@tirol-kliniken.at
    Scientific contact
    Ao. Univ.Prof. Dr. Bernhard Meister, Paediatrics I (hematoloy, oncoloy and stem cell transplantation) Anichstrasse 35, 6020 Innsbruck, +43 (0)512-504-23525, bernhard.meister@tirol-kliniken.at
    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
    31 Dec 2005
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2005
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2005
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the biologic activity of Irinotecan single drug treatment - when given on a prolonged schedule - in children with refractory or recurrent hepatoblastoma measured by tumour response rate and rate of early progression.
    Protection of trial subjects
    A new course of therapy should not begin until the absolute neutrophil count (ANC) has recovered to ≥ 1.0 G/L, the platelet count has recovered to ≥ 75 G/L, and treatement related diarrhea or other non-hematological toxicity is fully resolved. If the patient has not recovered after a 2 week delay, consideration should be given to discontinuing the trial. In patients who experience reversible grade 3-4 toxicity , a 20% dose reduction is permitted for the subsequent courses.
    Background therapy
    		 Management of side effects: 1. Administration of intravenous or subcutaneous atropine should be considered in patients experiencing diaphoresis, abdominal cramping or early diarrhea (dose of atropine 0.01mg/kg, maximum 0.4mg) 2. Late-onset diarrhea (onset more than 2 hours after completion of the Irinotecan infusion) should be treated with Loperamide with a maximum of 0.5mg/kg/day. 3. Administration of Irinotecan should be interrupted if neutropenic fever occurs.These patients should be hospitalised and treated with antibiotics. Subsequent doses of Irinotecan should be reduced. 4: Nausea and vomiting: Pre-medication and treatment with antiemetic agents - preferably the combination of a 5-HT3 blocker and dexamethasone - is recommended.
    Evidence for comparator
    		 No evidence for a comparator.
    Actual start date of recruitment
    20 Sep 2005
    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
    Austria: 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)
    1
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was open for children and young people with a refractory or recurrent hepatoblastoma - with or without metastases - after first or second line treatment.

    Pre-assignment
    Screening details
    		 Within the restrictions definded in the eligibility and exclusion criteria, all patients may entered the trial regardless of the type and duration of prior chemotherapy.

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

    Arms
    Arm title
    		 Irinotecan
    Arm description
    		 All patients included in the trial were treated with a total of 4 courses of Irinotecan given 3 weekly as single agent chemotherapy unless tumor progression occured or resectability of the tumor was achieved.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Campto
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan was available in 2mL and 5mL vials containing 40mg and 100mg, respectively. The approriate amount of irinotecan was mixed with 5% dextrose injection. Irinotecan was administered as a 60 minutes intravenous infusion at a dose of 20g/ m2 daily for 5 consecutive days and for 2 consecutive weeks repeated every 21 days (day 1-5 and day 8-12).

    Number of subjects in period 1
    		Irinotecan
    Started
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 1 1
    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)
    		 1 1
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Irinotecan
    Reporting group description
    		 All patients included in the trial were treated with a total of 4 courses of Irinotecan given 3 weekly as single agent chemotherapy unless tumor progression occured or resectability of the tumor was achieved.

    Primary: Response rate

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    End point title
    		 Response rate [1]
    End point description
    Subject showed CR
    End point type
    Primary
    End point timeframe
    The duration of overall response was measured from the time measurement criteria, that were met for CR (Complete Response) or PR (Partial Response) until the first date that recurrent or progressive disease was objectively documented.
    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 only one patient was enrolled in this trial no statistical analysis was done.
    End point values
    		 Irinotecan
    Number of subjects analysed
    1
    Units: Lesions [mm]
        number (not applicable)
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20.09.2005-31.12.2005
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Irinotecan
    Reporting group description
    		 All patients included in he trial will be treated with a total of 4 courses of irinotecan given 3 weekly as single agent chemotherapy unless tuor progression occurs or resectability of the tumor is achieved.

    Serious adverse events
    		 Irinotecan
    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
    		 Irinotecan
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Gastrointestinal disorders
    Diarrhoea
         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.
    Only one subject was enrolled in this trial.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22835780
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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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