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    Summary
    EudraCT Number:2011-003621-10
    Sponsor's Protocol Code Number:IC2011.05
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2011-12-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2011-003621-10
    A.3Full title of the trial
    CONSERVATIVE TREATMENT OF PATIENTS WITH RETINOBLASTOMA
    A.3.2Name or abbreviated title of the trial where available
    RETINO 2011
    A.4.1Sponsor's protocol code numberIC2011.05
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINSTITUT CURIE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportINSTITUT CURIE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CURIE
    B.5.2Functional name of contact pointSylvie MARAL
    B.5.3 Address:
    B.5.3.1Street Address26 RUE D'ULM
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75005
    B.5.3.4CountryFrance
    B.5.4Telephone number+33156245632
    B.5.5Fax number+33153104029
    B.5.6E-mailsylvie.maral@curie.net
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ALKERAN Injectable
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name CARBOPLATINE TEVA 10 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA BV
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCARBOPLATINE
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name ETOPOSIDE 20 mg
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMA BV
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    RETINOBLASTOMA
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10038918
    E.1.2Term Retinoblastoma NOS
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Traitements conservateurs des patients atteints de rétinoblastomes par chimio-thérapie néoadjuvante IV suivie de thermothérapie sans laser J8 :
    Evaluer le maintien de l’efficacité du traitement en termes de conservation oculaire et de recours à une radiothérapie externe chez les patients traités par une chimiothérapie néoadjuvante (VP16 carboplatine) suivie d’une combinaison chimiothérapie et laser (thermochimiothérapie TCT), tout en diminuant le nombre de traitements par laser.

    2. Traitements conservateurs des patients atteints de rétinoblastome par Melphalan intraartériel :
    Evaluer l’efficacité de la chimiothérapie par Melphalan, administrée par voie intra-artérielle super-selective, combinée à des traitements locaux , en termes de conservation oculaire et de recours à une radiothérapie externe.
    E.2.2Secondary objectives of the trial
    Poursuivre l’évaluation de l’efficacité de la stratégie conservatrice (traitements locaux suivant une phase de chimiothérapie néoadjuvante en cas de lésions n’étant pas accessibles directement aux traitements conservateurs oculaires).
    Réaliser une étude prospective des effets secondaires systémiques et oculaires, à court, moyen et long terme, de la chimiothérapie intraveineuse, intra-artérielle exclusive ou combinée aux trai-tements locaux.
    Evaluation radiologique de la réponse à la chimiothérapie intra-artérielle
    Etude dosimétrique de la scopie réalisée pendant les traitements intra-artériels.
    Chiffrer le risque de survenue d’une seconde tumeur à long terme.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Etude de chimiothérapie néoadjuvante IV suivie de thermothérapie sans laser de J8 :
    - Patients atteints de rétinoblastomes unilatéraux groupe A, B, C ou bilatéraux Groupe A, B, C, D (à l’exclusion des formes avec menace maculaire), accessibles à un traitement conservateur au moins d’un côté pour les atteintes bilatérales mais inaccessibles d’emblée à une thermochimio-thérapie en raison de la topographie des lésions, ou du diamètre et de l’épaisseur tumorales, (tumeur de plus de 4 mm de diamètre) ou entraînant un risque visuel ou de rechute vitréenne.
    - Non antérieurement traités par chimiothérapie ou radiothérapie pour cette tumeur ou un autre cancer.
    - Ne présentant pas de contre-indication aux traitements envisagés.
    - Pour lequel un suivi à long terme est possible.

    2- Etude de phase II du Melphalan IA :
    - Enfants atteints d’un rétinoblastome unilatéral Groupe C ou D.
    - Enfants atteints d’un rétinoblastome bilatéral très asymétrique avec un œil Groupe D et l’autre accessible à des traitements locaux sans chimiothérapie.
    - Non antérieurement traités par chimiothérapie ou radiothérapie pour cette tumeur ou un autre cancer.
    - Ne présentant pas de contre-indication aux traitements envisagés et au cathétérisme de l’artère ophtalmique par voie fémorale.
    - Pour lequel un suivi à long terme est possible.
    E.4Principal exclusion criteria
    1- Etude de chimiothérapie néoadjuvante IV suivie de thermothérapie sans laser de J8 :
    - Patients pour qui un traitement local conservateur est possible sans chimiothérapie néo-adjuvante tumeur de moins de 4 mm à distance de la macula ou du nerf optique
    - Patient présentant un rétinoblastome unilatéral groupe D (étendu) ou E pour qui une énucléa-tion est envisagée d’emblée ou après CT néoadjuvante.
    - Patient présentant un rétinoblastome bilatéral avec atteinte très asymétrique pour lequel un trai-tement conservateur local sans chimiothérapie est envisagée pour l’œil le moins atteint et un trai-tement par Melphalan IA pour l’œil le plus atteint.
    - Patients présentant un rétinoblastome avec atteinte extra oculaire.
    - Patient présentant une pathologie associée contre-indiquant la chimiothérapie.
    - Patient antérieurement traité par chimiothérapie ou irradiation externe ou pour une autre affection tumorale maligne.
    - contre indication à l’utilisation d’un des produits expérimentaux de l’étude mentionnée dans le RCP du Produit des produits expérimentaux de l’étude (cf. annexe 6 du Protocole).

    2 - Etude de phase II du Melphalan IA :
    - Patient présentant un rétinoblastome unilatéral groupe D (très étendu), ou E pour qui une énucléation est envisagée d’emblée ou après CT néoadjuvante.
    - Patients présentant un rétinoblastome avec atteinte extra oculaire.
    - Patient présentant une pathologie associée contre-indiquant la chimiothérapie.
    - Patient antérieurement traité par chimiothérapie, ou par irridiation externe ou pour une autre affection tumorale maligne.
    - contre indication à l’utilisation d’un des produits expérimentaux de l’étude mentionnée dans le RCP du Produit des produits expérimentaux de l’étude (cf. annexe 6 du Protocole).


    E.5 End points
    E.5.1Primary end point(s)
    Critère de succès pour les deux essais :
    Absence de recours à l’irradiation externe ou à l’énucléation secondaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 MONTHS
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    étude en fonction du degré de la pathologie
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned24
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 88
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state88
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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