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    Summary
    EudraCT Number:2009-010737-47
    Sponsor's Protocol Code Number:HSJD-RTB-QTIA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-04-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-010737-47
    A.3Full title of the trial
    Ensayo de fase II, no randomizado, abierto, unicéntrico, de quimioterapia intraarterial con melfalán para el tratamiento del retinoblastoma (RTB) en fase intraocular avanzada.

    Phase II trial, no randomized, open, one centre, of intraarterial quimiotherapy with melfalan for the treatement of retinoblastoma (RTB) in advanced intraocular phase.
    A.4.1Sponsor's protocol code numberHSJD-RTB-QTIA
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHOSPITAL SANT JOAN DE DÉU
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 MELFALAN GLAXOSMITHKLINE inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMELFALAN
    D.3.9.1CAS number 148-82-3
    D.3.9.3Other descriptive nameMELPHALAN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 UNILATERAL AVANZADO

    ADVANCED INTRAOCULAR RETINOBLASTOMA
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Valorar el salvamento de ojos afectos de RTB que hubiesen sido destinados a su enucleación, mediante exploración de fondo de ojo y exploración mediante RetCam, evaluadas en porcentaje de respuesta parcial (RP) o completa (RC) al tratamiento realizado.
    La respuesta se valorará en función de tamaño volumétrico tumoral mediante comparación entre imágenes obtenidas en exploraciones de fondo de ojo y RetCam sucesivas.
    E.2.2Secondary objectives of the trial
    El salvamento de ojos afectos de RTB destinados a la enucleación, la preservación del máximo porcentaje posible de agudeza visual en dichos ojos y su consecución mediante la ausencia de efectos secundarios importantes, tanto oftalmológicos como sistémicos y sin incrementar en ninguna mediada el riesgo vital de los pacientes elegidos.

    En colaboración con el proyecto inicial de Nueva York, se pretende ayudar a consolidar el tratamiento referido como alternativa a la enucleación en la mayoría de casos afectos de RTB intraocular avanzado y estudiar la posible indicación futura en otros estadios de RTB. 1. Preservar la agudeza visual, mediante el análisis del ojo afecto después del tercer ciclo de tratamiento.
    2. Modificar el resultado de los estudios electroretinográficos y de potenciales evocados visuales después del tercer ciclo de tratamiento.
    3. Evaluar la seguridad de la técnica y fármaco empleados, mediante la valoración de efectos secundarios tanto oftalmológicos como sistémic
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Serán candidatos al estudio todos aquellos pacientes con diagnóstico de RTB realizado por los oftalmólogos de la Unidad de RTB del Hospital Sant Joan de Déu de Esplugues de Llobregat, Barcelona (HSJDBCN).
    La elección de pacientes se realizará en el Comité de Tumores de la Unidad de Retinoblastoma del HSJDBCN (Dres Jaume Mora, Joan Prat, Ofelia Cruz, Andreu Parareda (IP) y Jaume Català), incluído en el Comité de Tumores del Departamento de Oncología del Desarrollo del HSJDBCN.
    Para su inclusión, deben cumplirse la totalidad de los siguientes criterios:
    1. Pacientes afectos de RTB unilaterales.
    2. Afectación intraocular avanzada, correspondientes a estadío D de la Clasificación Internacional (ver Apéndice 6.1), que hayan sido elegidos por el comité de Tumores de la Unidad de Retinoblastoma.
    A diferencia de los cánceres en general, en el caso del RTB está contraindicada la confirmación histológica previa al inicio del tratamiento, y en nuestro caso, cualquier biopsia practicada de la tumoración constituye criterio de exclusión. (ver 2.3.9 ).
    3. La única alternativa de tratamiento es la enucleación.
    4. Edad superior a seis meses en el momento del diagnóstico y menor de seis años.
    5. Consentimiento informado de los padres o representante legal.
    E.4Principal exclusion criteria
    Los pacientes no deben presentar ninguno de los siguientes criterios:
    1. Edad inferior a 6 meses en el momento del diagnóstico.
    2. Función renal anormal, con aclaramiento de creatinina inferior a 80mL/min/1,73m2 o creatinina sérica por encima de 0,7 mg/dL.
    3. Función hepática anormal, siendo definida la normal como bilirrubina total inferior a 1,5 veces el valor límite normal por edad y ALT inferior a 5 veces el valor límite normal por edad
    4. Pacientes con algún tipo de coagulopatía que impida el procedimiento o hayan tenido previamente al diagnóstico algún tipo de proceso trombótico.
    5. Anomalías cerebrales congénitas diagnosticadas previamente o detectadas mediante angioresonancia previa al tratamiento Afectación extraocular por RTB demostrada mediante técnicas de imagen, citología del líquido cefalorraquídeo (LCR) o citomorfología de aspirados de médula ósea (AMO), o expresión positiva de GD2 sintasa en LCR o AMO.
    6. Pacientes con enfermedades cardíacas, hipertensión arterial, otras enfermedades del sistema nervioso central distintas de las referidas en el punto 5 anterior, o con infecciones activas que impidan el procedimiento después de valoración por el Servicio de Anestesiología responsable del procedimiento.
    7. La no elección para el tratamiento quimioterápico intraarterial a través de arteria oftálmica por cualquier otro motivo distinto de los expuestos en el Comité de Tumores de la Unidad de RTB del HSJD.
    8. Administración concurrente de cualquier otro tratamiento antineoplásico.
    9. Cualquier procedimiento, quirúrgico o no, que haya podido alterar la estructura ocular y por lo tanto, favorecer el riesgo de diseminación, incluyendo la confirmación histológica previa al tratamiento.
    10. Participación en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Respuesta objetiva al tratamiento mediante exploración de fondo de ojo y exploración mediante RetCam, evaluadas en porcentaje de respuesta parcial (RP) al tratamiento realizado o respuesta completa (RC). La respuesta se valorará en función de tamaño volumétrico tumoral mediante comparación entre imágenes obtenidas en exploraciones RetCam sucesivas.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    Finalización del tratamiento con quimioterapia intraartrerial del último paciente reclutado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) No
    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 Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pacientes menores de edad. Por tanto el consentimiento lo han de dar los padres o representantes legales.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    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 Decision2009-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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