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    Summary
    EudraCT Number:2011-004391-11
    Sponsor's Protocol Code Number:RCC-DC-2011
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-09-14
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2011-004391-11
    A.3Full title of the trial
    Treatment of metastatic renal cell carcinoma using interleukin-12 secreting dendritic cells. Phase I/II clinical trial.
    Léčba metastázujícího renálního karcinomu s využitím dendritických buněk produkujících interleukin-12. Klinická studie fáze I/ II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of metastatic renal cell carcinoma by dendritic cells vaccination.
    Léčba metastázujícího renálního karcinomu s využitím vakcíny z dendritických buněk.
    A.4.1Sponsor's protocol code numberRCC-DC-2011
    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 SponsorMasaryk University
    B.1.3.4CountryCzech Republic
    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 supportMasaryk University
    B.4.2CountryCzech Republic
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMasaryk University
    B.5.2Functional name of contact pointDepartment of Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressKamenice 5
    B.5.3.2Town/ cityBrno
    B.5.3.3Post code625 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number00420549493070
    B.5.5Fax number00420549493070
    B.5.6E-maildemlova@med.muni.cz
    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 nameDendritic cells producing IL-12
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    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
    Metatastic renal cell carcinoma
    Metastazující renální karcinom
    E.1.1.1Medical condition in easily understood language
    Metatastic kidney cancer
    Metastazující karcinom ledvin
    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
    Study objective of the RCC-DC-2011 trial are to evaluate efficacy and safety of IL-12 producing DC vaccination in patients with metastatic renal cell carcinoma who are treated with Sunitinib or Sorafenib as the first line standard treatment.
    Primárním cílem studie je zhodnocení účinnosti a bezpečnosti léčivého přípravku u pacientů s metastatickým renálním buněčným karcinomem, kteří jsou léčeni Sunitinibem nebo Sorafenibem (v případě toxicity na Sunitinib).
    E.2.2Secondary objectives of the trial
    • Progression-free survival (PFS) 12 months after diagnosis of mRCC.
    • Overall survival (OS) in patients with mRCC.
    • Quality of life in patients treated with DC vaccination.
    • Immune response demonstrated by delayed type hypersensitivity (DTH) testing before, during and after the vaccination course, and by testing specific immune response in in vitro assays.
    Sekundárním cílem je stanovit medián času do progrese a celkovou dobu přežití pacientů léčených kombinací standardní léčby 1. linie a experimentální vakcinací dendritickými buňkami.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients, aged between 18-80 years.
    • Eligible for TKI treatment with Sunitinib or Sorafenib according the doctor's instructions.
    • The patients must undergo nephrectomy or nephron-sparing surgery or metastasectomy.
    • At least one measurable lesion at baseline as per the RECIST criteria, determined by CT scan or MRI.
    • ECOG performance status 0-1.
    • Histologically confirmed clear cell mRCC after surgery is necessary.
    • Written informed consent obtained prior to study entry.
    • Muži a ženy ve věku 18 - 80 let.
    • Histologicky potvrzený světlobuněčný renální karcinom. Pacient s nejméně jednou měřitelnou lézí v základní stupnici nádorové progrese podle RECIST kritérií, která je určená pomocí CT nebi MRI.
    • ECOG 0-1.
    • Negativní těhotenský test.
    • Adekvátní mechanická (kondom) a farmakologická (hormonální přípravek) antikoncepce žen před menopauzou (trvalou ztrátou menstruace) bránící otěhotnění v průběhu léčby.
    • Pacienti s metastatickým renálním karcinomem po nefrektomii, částečné nefrektomii nebo metastasectomii, kteří jsou léčeni Sunitinibem, p59padn2 Sorafenibem.
    • Negativní serologické testy (HIV1+2, Anti-HBc, HBsAg, anti-HCV, Treponema pallidum)
    • Podepsaný informovaný souhlas.
    E.4Principal exclusion criteria
    • Pregnancy or nursing.
    • Prior immune suppressive therapy (less than 4 week before screening).
    • Evidence of an active infectious disease or active autoimmune disease.
    • Other malignancies within the last 5 years.
    • Renal insufficiency requiring haemodialysis.
    • Impaired renal function (serum creatinine >2.0 times upper limit of normal (ULN).
    • Impaired hepatic function (ALT or AST >2.5 times ULN).
    • At least two out of three positive risk factors (modified from Molina et al.):
    • Lactate dehydrogenase >1.5 times ULN;
    • Serum calcium >2.5 mmol/l
    • Haemoglobin < 120 g/l (in women), < 130 g/l (in men).
    • Impaired haematological parameters, including WBC < 4x109/l, haemoglobin < 100 g/l, or platelet count <100x109/l.
    • History of significant cardiovascular disease (myocardial infarct <3 months, unstable angina, NYHA (New York Heart Assotiation) class II-IV, serious cardiac arrhythmia requiring medication).
    • Untreated hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg).
    • Sero-positivity for HIV1, 2, Treponema pallidium or active Hepatitis B or C infection.
    Neprovedení nefrektomie (ani částečné nefrektomie) nebo jiné okolnosti vyžadující alternativní protinádorovou léčbu jako je chemoterapie, immunosupresívní léčba nebo léčba pomocí cytokinů.
    Kojení, těhotenství.
    Aktivní infekční nebo autoimunitní onemocnění.
    Jiné malignity, které se vyskytly v posledních pěti letech.
    Renální insuficience vyžadující hemodialýzu.
    Zhoršené ledvinové funkce (kreatin-serum >2,0 krát vyšší než horní hranice normy=upper limit of normal - ULN)
    Zhoršené jaterní funkce (SGOT a SGPT >2,5 krát ULN)
    Zhoršené hematologické parametry včetně WBC <1000G/l, hemoglobinu <7,5 g/dl, destičky <100,0/mm3
    Závažné kardiovaskulární onemocnění (infarkt myokardu <3 měsíce, nestabilní angina pectoris, NYHA třída II-IV, hemodynamicky významná arytmie)
    Nekontrolovaná hypertenze.
    Seropositivita na HIV1,2, Treponema pallidium, hepatitis B, C.
    Intolerance léčby (toxicita stupně IV, CDC).
    E.5 End points
    E.5.1Primary end point(s)
    Safety of DC vaccination when combined with Sunitinib/Sorafenib.
    Progression free survival (PFS)
    Best overall response (BOR)
    Účinnost a bezpečnost léčivého přípravku, čas do progrese, celkové přežití
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after diagnosis
    12 měsíců od diagnózy
    E.5.2Secondary end point(s)
    Quality of life in patients treated with DC vaccination.
    Immune response demonstrated by delayed type hypersensitivity (DTH) testing before, during and after the vaccination course, and by testing specific immune response in in vitro assays.
    Zhodnocení statutu ECOG (Eastern cooperative Oncology Group).
    DTH (delayed type hypersensitivity) kožní test ke stanovení protinádorové imunity
    Imunologické in vitro rozbory k určení protinádorové imunitity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months after diagnosis
    12 měsíců od diagnózy
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Retrospectivně srovnáno s historickými kontrolami
    Retrospective comparison with historical control
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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
    NA
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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
    Ethical commision will take that responsibility temporarily in case the patient is uncounscious at the time of surgery. Patient must be consented whenever possible.
    Na zodpovědnost etické komise v případě bezvědomí pacienta v době operace. Pacient musí podepsat informovaný souhlas, jakmile to bude možné.
    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.4.2.2In the whole clinical trial 30
    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)
    NA
    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 Decision2012-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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