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    Summary
    EudraCT Number:2013-003632-71
    Sponsor's Protocol Code Number:DEND/TIA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-12
    Trial results View 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 number2013-003632-71
    A.3Full title of the trial
    Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
    INMUNOTERAPIA BASADA EN EL USO DE CÉLULAS DENDRÍTICAS EN TUMORES SÓLIDOS AVANZADOS DE NIÑOS Y ADULTOS JÓVENES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
    INMUNOTERAPIA BASADA EN EL USO DE CÉLULAS DENDRÍTICAS EN TUMORES SÓLIDOS AVANZADOS DE NIÑOS Y ADULTOS JÓVENES
    A.4.1Sponsor's protocol code numberDEND/TIA
    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 SponsorClínica Universidad de Navarra/Universidad de Navarra
    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 supportPor determinar
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClínica Universidad de Navarra
    B.5.2Functional name of contact pointUCICEC
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Pío XII, 36
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number34948255 4001142
    B.5.5Fax number34948296 667
    B.5.6E-mailucicec@unav.es
    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 No
    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 nameCélulas dendríticas autólogas
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCélulas dendríticas autólogas
    D.3.9.3Other descriptive nameAutologous peripheral blood differentiated adult dendritic cells from monocites and loaded with aoutologous tumor cell lysate
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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) Yes
    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
    Children and young adults with advanced solid tumours: relapsed or metastatic sarcomas or central nervous system tumours.
    Níños y adultos jóvenes con tumores sólidos avanzados: recidivas o metástasis de sarcomas o tumores del sistema nervioso
    E.1.1.1Medical condition in easily understood language
    Dendritic cell-based immunotherapy for advanced solid tumours of children and young adults
    Tratamiento complementario en tumores sólidos infantiles y adultos jóvenes
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the safety of the proposed treatment in terms of:
    - Effects attributable to the generation and administration of dendritic cells
    - Adverse effects during treatment
    - Autoimmunity
    El estudio propuesto tiene como objetivo primario evaluar la seguridad del tratamiento en estudio, mediante la evaluación de los:
    - Efectos atribuibles directamente a la obtención y administración celular,
    - Acontecimientos adversos durante el tratamiento,
    - Fenómenos autoinmunes.
    E.2.2Secondary objectives of the trial
    As secondary objectives we will analyze the effect of treatment with dendritic cells upon clinical parameters of efficacy
    - Reduction of tumoral lesions
    - Time to progression
    - Event-free survival
    - Overall survival
    - Quality of life according to EORTC tests

    Immunogenicity of the vaccine (biological efficacy) by in vitro analysis of the immune response:
    - Humoral response against autologue tumor cells, tumor lysates
    - Cellular response (prolifearation, cytokine production, specific cytotoxicity)
    - Phenotypic analysis of the different populations in peripheral blood

    Finally, we will characterize the cellular product and correlate the findings with clinical efficacy
    Como objetivos secundarios se valorará:
    El impacto del tratamiento en estudio sobre parámetros clínicos de eficacia
    - Disminución objetiva de las lesiones tumorales
    - Tiempo hasta progresión
    - Supervivencia libre de progresión
    - Supervivencia global
    - Calidad de vida medida según cuestionarios EORTC

    La inmunogenicidad de la vacuna (eficacia biológica) mediante estudios in vitro de la respuesta inmune humoral y celular

    - Respuesta humoral frente células tumorales autólogas/lisados tumorales
    - Respuesta celular (proliferación, producción de citoquinas, citotoxicidad específica)
    - Estudios fenotípicos de las poblaciones de sangre periférica

    Por último se caracterizará el producto celular y se correlacionarán los hallazgos con la eficacia clínica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients must fulfil the following inclusion criteria in order to be selected and participate in the study:
    1. Informed consent signed by the patient or his/her legal representative if minor
    2. Diagnosis of metastatic or relapsed sarcoma or high grade central nervous system tumor
    3. Age between 3 and 40 years-old
    4. The patient will receive the standard treatment for his disease, including surgery, In patients with CNS tumors residual tumor volume after surgery should be minimal
    5. The patient must be able to fulfil all the clinical trial assay requirements, according to the researcher´s criteria.

    All patients must fulfil the following inclusion criteria in order to receive the experimental treatment:
    6. Tumor availability and possibility to obtain dendritic cells (apheresis)
    7. Development of enough quantity of mature dendritic cells to initiate treatment
    8. Negative pregnancy test
    Todos los pacientes deben cumplir los siguientes criterios de inclusión para poder ser seleccionados y participar en el estudio:

    1. Consentimiento informado otorgado por el paciente o su representante legal, en el caso de pacientes menores de edad.

    2. Pacientes con diagnóstico de sarcoma metastásico o recidivado o tumor de alto grado del SNC.

    3. Edad de 3 a 40 años.

    4. El paciente va a recibir el tratamiento estándar para su enfermedad, en el que se incluye la realización de cirugía. En los pacientes con tumores del SNC el volumen tumoral residual tras la cirugía deberá ser mínimo

    5. El paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.



    Criterios de inclusión para la administración del tratamiento en estudio:

    Todos los pacientes seleccionados podrán recibir el tratamiento en estudio si se cumplen los siguientes criterios:

    6. Disponibilidad de tumor adecuado y posibilidad de conseguir células dendríticas (aféresis).

    7. Desarrollo de suficiente cantidad de células dendríticas maduras para iniciar el tratamiento.

    8. Test de embarazo negativo.
    E.4Principal exclusion criteria
    Patients who present any of the following characteristics will not be admitted in the clinical trial:
    1. Liver, renal or bone marrow toxicity that advise against the patients´s participation, according to the researcher´s criteria
    2. Pregnant women or in breastfeeding period
    3. Diagnosis of any other cancer, except basal cell carcinoma, treated cervical carcinoma or any other tumor type in remission for a period longer than three years.
    4. Patients who need immunosuppressive treatment
    5. Active infection by HIV, HBV, HCV or syphilis
    6. Complete contraindication to receive the remaining standard treatment against the tumour (chemo and/or radiotherapy and surgery).
    Los pacientes que presenten alguno de los siguientes criterios de exclusión no podrán participar en el ensayo clínico:

    1. Toxicidad o insuficiencia hepática, renal o medular que desaconsejen la participación del paciente en el estudio, según el criterio del investigador.

    2. Mujeres embarazadas o en período de lactancia.

    3. Pacientes diagnosticados de otras neoplasias, salvo carcinoma de células basales escamosas de piel, carcinoma cervical in situ adecuadamente tratado u otros tumores tratados de forma curativa sin recidiva durante 3 o más años. Se valorarán individualmente los casos en que coexistan tumores de buen pronóstico a largo plazo.

    4. Pacientes que precisen medicación inmunosupresora.

    5. Infección activa por VIH, hepatitis B (HbsAg positivo), hepatitis C o sífilis.

    6. Contraindicación absoluta para recibir los restantes tratamientos estándar para el cáncer que padece (quimioterapia, cirugía, radioterapia)
    3. Pacientes diagnosticados de otras neoplasias, salvo carcinoma de células basales escamosas de piel, carcinoma cervical in situ adecuadamente tratado u otros tumores tratados de forma curativa sin recidiva durante 3 o más años. Se valorarán individualmente los casos en que coexistan tumores de buen pronóstico a largo plazo.
    4. Pacientes que precisen medicación inmunosupresora.
    5. Infección activa por VIH, hepatitis B (HBsAg), hepatitis C o Sífilis VDRL
    6. Contraindicación absoluta para recibir los restantes tratamientos estándar para el cáncer que padece (quimioterapia, cirugía, radioterapia)
    E.5 End points
    E.5.1Primary end point(s)
    Primary end points are safety of treatment and clinical efficacy (decrease of the size of the lesion, event-free survival and overall survival of vaccinated patients)
    Las variables primarias son la seguridad del tratamiento y la eficacia clínica (disminución del tamaño del tumor y supervivencia global de los pacientes vacunados)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points will be evaluated during treatment and afterwards, following the completion of vaccination. Regular follow-up of patients will continue over a period of three years. After this time, the patient will be still followed but outside the context of this clinical trial.
    Las variables primarias serán evaluadas durante el tratamiento y posteriormente una vez completado el tratamiento con las vacunas. Además el seguimiento de los pacientes continuará durante un periodo superior a tres años. Después de este tiempo se continuará siguiendo al paciente pero fuera del ensayo clínico
    E.5.2Secondary end point(s)
    Secondary end points are studies of specific immune response induced by the vaccine (determination of antibodies and cellular immune response).
    Las variables secundarias respuesta inmunológica antitumoral inducida para la vacuna (determinación de anticuerpos y respuesta celular inmune)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The immune response studies will be performed two weeks after the last vaccine for each patient. Therefore, the time point for this end point will be two months after the last vaccine for each patient.
    El estudio de respuesta inmune se llevará a cabo dos semanas después de la administración de la última vacuna a cada paciente. De este modo el periodo de evaluación será dos meses después de la última vacun a para cada paciente.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    New diagnostic indication and new age range, including pediatric patients
    Nueva indicación diagnóstica y nuevo rango de edad, incluyendo pacientes pediátricos
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    E.8.1.2Open No
    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 No
    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 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 No
    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
    LVLS
    LVLS
    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.1.1Number of subjects for this age range: 10
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 3
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patient must be between 3 and 40 years old.
     Patients diagnosed with metastatic sarcoma or recurrent high-grade tumor or CNS
    El paciente deberá tener entre 3 y 40 años de edad.
    Pacientes con diagnóstico de sarcoma metastásico o recidivado o tumor de alto grado del SNC
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    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 Decision2014-07-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
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