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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-005238-19
    Sponsor's Protocol Code Number:CD-2007-01
    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:2010-11-25
    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 number2006-005238-19
    A.3Full title of the trial
    Estudio fase II con inmunoterapia mediante células dendríticas y linfocitos infiltrantes de tumor en tumores sólidos
    A.4.1Sponsor's protocol code numberCD-2007-01
    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 SponsorInstituto Cientifico y Tecnologico 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 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 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 nameAutologous dendritic cells
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntralesional use
    Intralymphatic use
    Intraperitoneal use
    Intrapleural use
    Intravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAutologous dendritic cells
    D.3.10 Strength
    D.3.10.1Concentration unit EID50 50% Embryo Infective Dose
    D.3.10.2Concentration typeup to
    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) Information not present in EudraCT
    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 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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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
    Melanoma, renal cell carcinoma, hepatocarcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10007050
    E.1.2Term Cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Response rate
    E.2.2Secondary objectives of the trial
    Immunologic response
    Overall survival
    Progression-free survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Podrán ser incluidos en el estudio los pacientes que cumplan los siguientes requisitos:
    1. Edad superior a 18 años
    2. Diagnóstico confirmado histológicamente de:
    -melanoma metastásico a nivel subcutáneo o partes blandas (estadios III no resecables o M1a) o metástasis pulmonares (M1b).
    - carcinoma renal de células claras avanzado no susceptible de tratamiento curativo
    - hepatocarcinoma no susceptible de tratamiento curativo, con función hepática estadio IB de Child o menor. Se podrán incluir pacientes en los que se haya realizado tratamiento con embolización si se considera necesario.
    3. Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio.
    4. Enfermedad medible según los criterios RECIST (v. apéndice 3).
    5. Situación basal <2 según la escala ECOG (v. apéndice 4)
    6. Adecuada función hepática, renal y medular, definidas por los siguientes parámetros obtenidos en los 14 días previos al inicio del tratamiento del estudio:
    - Creatinina sérica <1.5 x el límite superior de normalidad del laboratorio (LSN)
    - SGOT y SGPT <5 x LSN
    - Bilirrubina sérica <2 x LSN (confirmar si es aceptable para hepatocarcinoma)
    - Leucocitos >3000/ mm3, plaquetas >5.000/ mm3.
    7. Pruebas serológicas negativas frente a VIH.
    8. Disponibilidad de tejido tumoral que permita madurar las células dendríticas y, en los casos en que se considere necesario, obtener células TIL. Si no existe tejido tumoral disponible, se valorará la realización de nuevas biopsias, pero teniendo en cuenta el carácter investigacional del tratamiento, no se propondrá la realización de biopsias que requieran cirugía mayor o de zonas que por su localización o por su proximidad a otras estructuras conlleven un riesgo considerable de hemorragia, perforación de víscera hueca, neumotórax u otras complicaciones relevantes.
    E.4Principal exclusion criteria
    1. Infección o enfermedades graves que desaconsejen la participación del paciente en el estudio, según el criterio del investigador.
    2. Participación en otro ensayo clínico. En el caso de que el paciente haya participado previamente en otro ensayo, se deberá esperar un tiempo de lavado y de recuperación determinado por el investigador, antes de tratar al paciente en este estudio.
    3. Administración concurrente de otro tratamiento antitumoral. En el caso de que el paciente haya recibido otro tratamiento previamente, se deberá esperar un tiempo de lavado, cuya duración la determinará el investigador.
    4. Pacientes diagnosticados de otras neoplasias, salvo carcinoma de células basales o escamosas de piel, carcinoma cervical in situ adecuadamente tratados, así como otros tumores que tratados de forma curativa sin recidiva durante al menos 3 años.
    5. Mujeres embarazadas o en período de lactancia. Mujeres que puedan quedar embarazadas durante el tratamiento.
    6. Pacientes que precisen medicación inmunosupresora.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate
    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 Yes
    E.6.7Pharmacodynamic Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state41
    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)
    State of the art treatment upon progression (no treatment required if no progression)
    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 Decision2007-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
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