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    Summary
    EudraCT Number:2006-002202-54
    Sponsor's Protocol Code Number:Dandrit 02, April 2006
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-19
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-002202-54
    A.3Full title of the trial
    Vaccination med autologe dendritiske celler pulset med allogent tumorlysat (MelCancerVac) til behandling af patienter med avanceret eller metastatisk ikke-småcellet lungecancer
    A.3.2Name or abbreviated title of the trial where available
    MelCancerVac_NSCLC
    A.4.1Sponsor's protocol code numberDandrit 02, April 2006
    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 SponsorDandrit Biotech A/S
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Information not present in EudraCT
    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 Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMelCancerVac
    D.3.9.3Other descriptive nameautologe dendritiske celler pulset med allogent tumorlysat
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,2 ml to injektion
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    avanceret eller metastatisk ikke-småcellet lungecancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    undersøge virkningen af vaccination med autologe dendritiske celler pulset med et allogent tumorlysat (MelCancerVac) på patienter med avanceret, dissimineret ikke-småcellet lungecancer
    E.2.2Secondary objectives of the trial
    at vurdere patienternes livskvalitet via et spørgeskema, at måle overlevelsestid og respons ihenhold til RECIST kriterierne
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Alder > 18 år
    2. Patienter med inoperabel lokoregional eller avanceret NSCLC uanset histologisk subtype, hvor de kemoterapeutiske behandlingsmuligheder vurderes at være udtømte
    3. Histologisk eller cytologisk bekræftet diagnose
    4. Adgang til histologisk tumormateriale fra patienten
    5. Pkt. 5 udgået/slettet ultimo 2006
    6. Performance < 2 (Eastern Cooperative Oncology Group (ECOG) performance scale)
    7. Forventet restlevetid på minimum 12 uger
    8. Inklusion skal ske mindst 4 uger efter sidste dosis af kemoterapi.
    9. Inklusion skal ske mindst 4 uger efter sidste strålebehandling
    10. Inklusion skal ske mindst 1 uge efter sidste behandling med immunsupprimerende medicin (herunder Prednisolon)
    11. Patienter, som er kommet sig (CTC<1) fra den akutte toksicitet i forbindelse med enhver anden tidligere behandling.
    12. Granulocyt tal ≥ 1.5 x 109 / L og trombocyt tal > 100 x 109 / L
    13. Serum bilirubin ≤ 1.5 øvre normal grænse (ULN)
    14. ASAT og/eller ALAT ≤ 2 x ULN (eller ≤ 5 x ULN hvis grundet levermetastaser)
    15. Lever og nyretal < 2 x ULN, dog kan LDH være forhøjet uden begrænsning.
    16. Serum kreatinin ≤ 1.5 ULN eller kreatinin clearance ≥ 60 ml / min.
    17. Kvinder i den fertile alder skal anvende sikker antikonception.
    18. Mindst én målbar parameter efter RECIST kriterier
    19. Underskrevet samtykkeerklæring efter såvel mundtlig som skriftlig information.
    20. Patienten skal være villig til at anvende adjuvanserne (celecoxib (200 mg/dgl.), Jern C (100 mg/dgl.), Aldara creme 5 % og IL-2) fra 1. vaccination og til udgang af forsøget, medmindre bivirkninger nødvendiggør seponering.
    E.4Principal exclusion criteria
    1. Malign sygdom indenfor de sidste 5 år.
    2. Pkt. 2 udgået/slettet ultimo 2006
    3. Enhver form for ustabil systemisk sygdom, inkluderende akut infektion og grad 4 hypertention, ustabil angina, hjertesygdom, samt lever- og nyresygdomme og metaboliske sygdomme
    4. Patienter, der ikke kan indtage medicin per-oralt eller tidligere fået foretaget kirurgiske indgreb, der afficerer fødeoptagelse
    5. Patienter med nuværende eller tidligere ulcussygdom eller dyspeptiske gener de sidste 3 måneder. Dog kan patienter, der indtager antacida, H2 blokkere eller PPI inkluderes
    6. Alvorlig medicinsk lidelse, f.eks. svær astma, dårlig reguleret hjerte/kar sygdom
    7. Akut/kronisk infektion med f.eks. HIV, hepatitis, tuberkulose
    8. Alvorlig allergi eller tidligere anafylaktiske reaktioner
    9. Autoimmune sygdomme (f.eks. Autoimmun neutropeni/trombocytopeni eller hæmolytisk anæmi, systemisk lupus erythematosus, Sjøgrens syndrom, sclerodermi, myastenia gravis, Goodpastures syndrom, Addisons sygdom, Hashimotos tyroiditis, aktiv Graves sygdom)
    10. Gravide og ammende kvinder
    11. Psykiatriske lidelser, som ifølge investigators mening kan indvirke på patientens compliance med forsøget.
    12. Kendt overfølsomhed overfor indholdsstofferne i adjuvanserne (celecoxib, Jern C, Aldara creme, ”plaster”, IL-2)
    13. Samtidig behandling med immunsupprimerende medicin (herunder Prednisolon)
    14. Samtidig behandling med andre eksperimentelle stoffer
    15. Samtidig anden systemisk anticancerbehandling.
    E.5 End points
    E.5.1Primary end point(s)
    at måle den specifikke immunologiske reaktion mellem vaccineantigener og patienternes immunsystem hvilket måles

    in vivo ved hudtest med lokal reaktivitet (DTH) mod MelCancerVac og
    in vitro ved måling af MelCancerVac specifikke T lymfocytter i perifert blod (ELISPOT)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Yes
    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) 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    sidste patients sidste besøg
    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 days
    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 Information not present in EudraCT
    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 2006-05-19. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    såfremt en patient stadig responderer på behandling efter endt primær og responderforløb kan off study behandling tilbydes, ellers tilbydes ingen behandling udover den i protokollen beskrevet forsøgsbehandling
    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 Decision2006-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-01
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