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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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:2008-001436-12
    Sponsor's Protocol Code Number:ITCC-013-TOTEM2
    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:2010-03-03
    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 number2008-001436-12
    A.3Full title of the trial
    Estudio Fase II no aleatorizado de tratamiento con Temozolamida combinada con Topotecan para neuroblastoma y otros tumores sólidos pediátricos en situación de recaída o progresión. "Phase 2 single-arm studies of Temozolamide incombination with Topotecan in refractory and relapsed neuroblastoma and other paediatric solid tumours"
    A.4.1Sponsor's protocol code numberITCC-013-TOTEM2
    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 SponsorFUNDACION PARA LA INVESTIGACION LA FE
    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 TEMODAL 5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH EUROPE
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPBuccal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTEMOZOLOMIDA
    D.3.9.1CAS number 85622-93-1
    D.3.9.3Other descriptive nameTEMOZOLOMIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 HYCAMTIN 4 mg polvo concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderSMITHKLINE BEECHAM PLC
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOPOTECAN HIDROCLORURO
    D.3.9.3Other descriptive nameTOPOTECAN HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Neuroblastoma, tumores cerebrales diferentes al meduloblastoma u otros tumores sólidos diversos en población pediátrica (de 6 meses a 20 años).
    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
    Evaluar la tasa de respuesta del la combinación de Temozolamida con Topotecan en pacientes diagnosticados de:
    o Neuroblastoma en recaída o progresión.
    o Tumores cerebrales diferentes de Meduloblastoma en recaída o progresión.
    o Otros tipos de tumores sólidos infantiles igualmente en recaída o progresión.
    E.2.2Secondary objectives of the trial
    - Determinar la duración de la respuesta, tiempo de progresión de la enfermedad, el tiempo para el fracaso del tratamiento y la supervivencia global.
    - Evaluar posibles efectos adversos y toxicidades de la combinación.
    - Evaluar la expresión del gen MGMT en muestras de material tumoral y la correlación con la respuesta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnostico confirmado por citología o histología (al diagnostico, no es necesaria una biopsia adicional para la inclusión en el estudio).
    - Se incluirán tumores que se encuentren en recaída o progresión de su enfermedad original y cuyos tratamientos estándar hayan fallado.
    - No mas de 2 líneas de quimioterapia previas.
    - La enfermedad primaria y/o la enfermedad metastásica debe ser medible por CT/MRI: al menos una lesión debe ser medible bi-dimensionalmente. Para pacientes diagnosticados de Neuroblastoma la enfermedad medible vienen definida por los criterios del INSS (International Neuroblastoma Staging System)(Brodeur et al. 1993). Completado con evaluación de la enfermedad mediante MIBG.
    - Edad en el momento de la inclusión de 6 meses a 20 años.
    - Lansky score &#8805; 70% o el estado funcional ECOG &#8804; 1
    - Esperanza de vida &#8805; 3 meses
    - Función de órganos adecuada:
    o Función hematológica adecuada: Hemoglobina &#8805; 80g/L, recuento de neutrofilos: &#8805; 1.0 x 109/L, recuento de plaquetas &#8805; 100 x 109/L. En caso de enfermedad en medula ósea: neutrofilos &#8805; 0.5 x 109/L y plaquetas &#8805; 75 x 109/L;
    Función renal adecuada: creatinina normal adecuada a la edad del paciente:
    • 0-1 año: &#8804; 40 &#956;mol/L
    • 1-15 años: &#8804; 65 &#956;mol/L
    • 15-20 años: &#8804; 110 &#956;mol/L
    o Función hepática adecuada: bilirrubina &#8804; 1.5 x ULN; AST y ALT &#8804; 2.5 x ULN (AST, ALT &#8804; 5 x ULN en caso de metástasis en hígado).
    - Haber pasado al menos 4 semanas desde el tratamiento con quimioterapia, 6 semanas si el tratamiento incluye nitrosoureas, 2 semanas en caso de tratamiento solo con Vincristina, 6 semanas en caso de radioterapia previa (excepto en caso de radioterapia paliativa o en que las lesiones no sean medibles).
    Los pacientes deben haberse recuperado de los efectos tóxicos agudos de todas las anteriores terapias antes de la inclusión en el estudio.
    - Pacientes tratados anteriormente con solo una de las dos drogas en estudio son elegibles.
    - Capaces de cumplir con el seguimiento previsto y con la monitorización de la toxicidad.
    - Todas las pacientes en edad fértil debe usar un método anticonceptivo eficaz de control de la natalidad mientras estén en el estudio. Las pacientes de edad mayor de 12 años deben tener un test de embarazo negativo dentro de los 7 días previos al comienzo del tratamiento del estudio.
    - Consentimiento informado firmado por los padres o por los tutores legales del paciente en caso de ser menor de edad, en caso de ser mayor de edad el consentimiento informado debe estar firmado por el paciente.
    E.4Principal exclusion criteria
    - Administración concomitante de cualquier otra terapia antitumoral.
    - Grave enfermedad sistémica concomitante (por ejemplo, infección activa, incluido el VIH o enfermedades cardiacas) que, en opinión del investigador, puedan comprometer la capacidad del paciente para completar el estudio
    - Historia de reacción alérgica a los componentes o sus disolventes de la medicación en estudio.
    - Historia de reacción alérgica al Dacarbazine (DITC)
    - Galactosemia, mala absorción de glucosa-galactosa o deficiencia de lactasa.
    - Embarazadas o mujeres jóvenes en periodo de lactancia.
    - La presencia de metástasis cerebrales sintomáticas en pacientes con tumores de sistema nervioso central.
    E.5 End points
    E.5.1Primary end point(s)
    El principal criterio de eficacia es la respuesta tumoral después de 2 ciclos = 8 semanas de tratamiento.
    El mismo método de evaluación radiológica pues ser usado tanto para la inclusión como para las evaluaciones de la respuesta al tratamiento:
    - Neuroblastoma: CT scan, MRI, MIBG. Se recomienda aspirados de medula ósea y biopsia.
    - Tumores cerebrales: MRI.
    Opcional: MRI funcional, gammagrafía con talio y escáner PET con Metionina.
    - Otros tumores sólidos: CT, MRI.
    Opcional: Ganmagrafia, aspirados de medula ósea y biopsias.
    La variable principal de evaluación de la eficacia es el porcentaje de pacientes que consiguieron una respuesta completa o parcial después de haber recibido 2 ciclos de Temozolomida - Topotecán (8 semanas).
    Cualquier CR y RP deberá ser confirmado de 4-6 semanas después con el mismo método radiológico.
    En los pacientes diagnosticados de Neuroblastoma la respuesta del tumor debe ser medida usando los criterios del INRC (International Neuroblastoma Response Criteria completados con score de MIBG. Para otros tumores la respuesta del tumor debe ser medida usando los criterios de la OMS. La eficacia se evaluará por separado en los 3 cohortes.
    Un comité externo revisará todos los resultados para validar las respuestas y los posibles fallos. Se confirmará la respuesta/estabilidad de la enfermedad cada 2 ciclos (2 meses) hasta la progresión del tumor o discontinuación del estudio. Los siguientes seguimientos se realizarán cada 3-4 meses.
    Las variables secundarias de eficacia son la duración de la respuesta, el tiempo hasta el fallo del tratamiento, el tiempo hasta la progresión de la enfermedad y la supervivencia global. La respuesta tumoral (completa o parcial) después de la evaluación de 2 ciclos será considerada en el análisis final.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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) Yes
    F.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-03-03. Yes
    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
    Menores (de 6 meses a 20 años)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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 Decision2010-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-10
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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