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    Summary
    EudraCT Number:2010-020233-56
    Sponsor's Protocol Code Number:DC-006
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-05-05
    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 ConcernedNorway - NOMA
    A.2EudraCT number2010-020233-56
    A.3Full title of the trial
    PHASE I/II TRIAL OF VACCINE THERAPY IN RELAPSED AND PLATINUM RESISTANT EPITHELIAL OVARIAN CANCER PATIENTS USING AUTOLOGOUS DENDRITIC CELLS LOADED WITH AMPLIFIED OVARIAN CANCER STEM CELL mRNA, hTERT mRNA AND SURVIVIN mRNA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II trial of vaccine therapy in patients with recurrent ovarian cancer.
    A.3.2Name or abbreviated title of the trial where available
    DC vaccine ovarian cancer
    A.4.1Sponsor's protocol code numberDC-006
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportOslo University Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointSteinar Aamdal
    B.5.3 Address:
    B.5.3.1Street AddressPostbox 4953 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number4722934000
    B.5.5Fax number4722935808
    B.5.6E-mailsteinar.aamdal@medisin.uio.no
    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 nameDentritic cell vaccine
    D.3.2Product code Dentritic cell vaccine
    D.3.4Pharmaceutical form Solution 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.3.9.3Other descriptive nameDendritic cells loaded with amplified ovarian cancer stem cell mRNA, hTERT mRNA and Survivin mRNA
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number200 to 400
    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
    Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.
    E.1.1.1Medical condition in easily understood language
    Patients with ovarian cancer that have already been treated with surgery and chemotherapy.
    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
    Safety and toxicity of vaccination with DCs transfected with amplified ovarian cancer stem cell mRNA, h-TERT mRNA and survivin mRNA in patients with relapsed and platinum resistant ovarian cancer.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •Determine immunological response to the vaccine (induction of specific T-cell response) and time of disease progession and survival time.
    •Monitor clinical treatment response with clinical examination, CA-125 evaluation and CT scans every third month.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Histologically confirmed epithelial ovarian cancer. Histologic documentation of the original primary tumor is required via pathology report.
    •Completed first line treatment (surgery and adjuvant or neoadjuvant treatment with carboplatine and paclitaxel)
    •Residual tumor ≤1 cm after primary surgery
    •Relapsed and platinum resistant epithelial ovarian carcinoma patients that have received one line of non-platinum chemotherapy in resistance disease setting.
    •Start of vaccine therapy within 4-6 weeks after end of last chemotherapy regimen.
    •If surgery is indicated, the patient should be surgically treated and then starts vaccination with a minimum interval of 28 days.
    •Must be ambulatory with an ECOG performance status 0 or 1.
    •Life expectancy ≥ 6 months
    •Must be of 18-75 years of age
    •Must have lab values as the following:
    -ANC ≥ 1.5 x 109/L
    -Platelets ≥ 100 x 109/L
    -Hb ≥ 9 g/dL (≥ 5.6 mmol/L)
    -Creatinine ≤ 140 ╬╝mol/L (1.6 mg/dL); if borderline, the creatinine clearance ≥ 40 mL/min
    -Bilirubin within the upper limit of normal
    -ASAT and ALAT ≤ 2.5 the upper limit of normal
    -Albumin levels above lower normal value
    •If the patient has preserved fertility after primary treatment, she must practice adequate contraception during the study treatment
    •Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    •Eligible to otherwise curative treatment.
    •History of prior malignancy, other than ovarian cancer, within the last 5 years, with the exception of curatively treated basal cell carcinoma and cancer in situ cervix uteri.
    •Prior surgery within the past 28 days
    •Symptoms of the recurrent disease that can be treated by chemotherapy.
    •Active infection requiring antibiotic therapy.
    •Have known active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis). Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out brain metastasis.
    •Significant cardiac or other medical or mental illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, serious cardiac arrhythmia or psychosis.
    •Pregnancy or lactation
    •Previous adverse reactions to vaccines such as asthma, anaphylaxis or other serious reactions.
    •History of immunodeficiency or autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis-dermatomyositis, juvenile onset insulin dependent diabetes, or a vasculitic syndrome.
    •Positive for HIV, Hepatitis B and C tests
    •Use of systemic glucocorticoids.
    •Prior anti-cancer treatment, including radiotherapy, chemotherapy immunotherapy and/or immunomodulating agents stopped for less than 4 weeks before first study treatment administration. Anti hormonal treatment, such as Tamoxifen, may continue until first study treatment administration.
    •Previous treatment with dacarbazin or temozolomide at any time prior to study entry
    •Any reason why, in the opinion of the investigator, the patient should not participate
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point of this study is: Safety and toxicity of the vaccination with mRNA transfected DCs in terms of occurrence of related adverse events, especially grade 3/4 adverse events assessed by reference to the NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Those endpoints are evaluated continously. Patients are coming every 4 weeks to the site during the 3 years vaccination period.
    E.5.2Secondary end point(s)
    The secondary end-points of this study are:
    •Biochemistry and hematology results, vital signs and ECOG performance status.
    •Evaluation of immunological responses in terms of SI ≥ 2 or delta ≥ 10.000 measured by the 3H-thymidine proliferation test.
    •Evaluation of clinical responses in terms of time to disease progression, also slow progressive disease, and survival time measured from the time of study-enrolment.


    E.5.2.1Timepoint(s) of evaluation of this end point
    Biochemistry and hematology results, vital signs and ECOG performance status will be measured every 4 weeks.

    Immune response will be measured 8 and 12 weeks after start of vaccination and every 3 months thereafter.

    Clinical response will be evaluated via:
    -measurement of CA-125 every 4 weeks
    -physical examination every 3rd months
    -CT taken every 3rd months
    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 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 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
    End of trial when 20 patients have undergone the treatment and follow up period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    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 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: 10
    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 No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    As provided in the protocol.
    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 Decision2011-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-24
    P. End of Trial
    P.End of Trial StatusOngoing
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