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    Summary
    EudraCT Number:2013-002723-42
    Sponsor's Protocol Code Number:HH1222
    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:2013-08-22
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2013-002723-42
    A.3Full title of the trial
    Electrochemotherapy of Head and Neck Cancer
    Elektrokemoterapi af hoved-hals cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Electrochemotherapy of Head and Neck Cancer
    Elektrokemoterapi af hoved-halskræft.
    A.3.2Name or abbreviated title of the trial where available
    Electrochemotherapy of Head and Neck Cancer
    Elektrokemoterapi af hoved-hals cancer.
    A.4.1Sponsor's protocol code numberHH1222
    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 SponsorRigshospitalet
    B.1.3.4CountryDenmark
    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 supportRigshospitalet, Øre-Næse-Hals Kirurgisk Klinik
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet
    B.5.2Functional name of contact pointØre-Næse-Hals Kirurgisk Klinik
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004535452071
    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 Bleomycin
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter A/S, Gydevang 43, 3450 Allerød, Denmark
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBLEOMYCIN SULFATE
    D.3.9.1CAS number 9041-93-4
    D.3.9.4EV Substance CodeSUB00844MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    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) No
    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 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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeIt is a glycopeptide antibiotic used as an anticancer agent
    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
    Head and Neck Cancer.
    We would like to investigate the possible use of electrochemotherapy in recurrent head and neck cancer. Surgery and radiotherapy, with the possible addition of chemotherapy, cures a large part of patients with head and neck cancer. However, in the event of recurrence curative options may be exchausted and the patient is referred for palliative chemotherapy. It is for this patient group, that we would like to propose electrochemotherapy in a clinical
    trial.
    Kirurgi og strålebehandling, eventuelt i kombination med kemoterapi, helbreder i dag en stor del af patienter med hovedhalskræft, og ved recidiv af sygdommen kan man i visse tilfælde operere eller strålebehandle yderligere. Imidlertid er der en patientgruppe som henvises til lindrende kemoterapi fordi der ikke er mulighed for yderligere lokal behandling. Disse patienter vil vi gerne tilbyde elektrokemoterapi, som forsøgsbehandling.
    E.1.1.1Medical condition in easily understood language
    Recurrent Head and Neck Cancer
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10068476
    E.1.2Term Electrochemotherapy
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Electric pulses may be used to transiently permeabilise cell membranes, enabling passage of otherwise non-permeating molecules. This dramatically enhances the cytotoxic effect of certain chemotherapeutic agents, and is termed electrochemotherapy.

    We would like to investigate the possible use of electrochemotherapy in recurrent head and neck cancer. Surgery and radiotherapy cures a large part of patients with head and neck cancer. However, in the event of recurrence curative options may be exhausted. It is for this patient group, that we propose electrochemotherapy in a clinical trial.

    The electrochemotherapy is administered as a once-only treatment, with possible retreatment after eight weeks. Under general anesthesia, chemotherapy (Bleomycin) is administered, followed by application of electric pulses to the tumor area. Before treatment, the location and spread of the tumor is determined by imaging.

    Main objective is evaluation of tumor response on PET/CT scans.
    E.2.2Secondary objectives of the trial
    The trial includes evaluation of response by MRI and PET/CT-scans, tissue samples, as well as adverse events registration and questionnaires on quality of life.

    We will compare the different modalities for evaluating the effect of electrochemotherapy; CT scan, MRI scan, PET scan, biopsies and a clinical photography. Resulting in a guideline for future response evaluation to electrochemotherapy in the head and neck area.

    An evaluation of the utility of electrochemotherapy in the head and neck area. Is it usable to apply the treatment on mucosal tumors in the mouth and pharynx? Is the treatment tolerable for the patients?

    This project shall visualize the response of electrochemotherapy in the treatment of head and neck cancer, and gather as many information’s regarding the patients wellbeing, the cellular response and image modality during the treatment. Thereby enabling us to construct a guideline for future treatment with electrochemotherapy in head and neck cancer.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically verified cancer of any type in the head and neck area.
    2. Progressive and/or metastatic disease
    3. Primary disease not eligible for surgery for patient’s general conditions or for the need of extensive surgery
    4. Patients must have been offered standard treatments
    5. Measurable lesions suitable for application of electric pulses
    6. Age> 18 yrs
    7. Performance status (Karnofsky ≥ 70; WHO ≤ 2)
    8. Life expectancy> 3 months
    9. Treatment free interval of at least 4 weeks after previously applied chemo- or radiotherapy to the target lesions
    10. Patients must be mentally capable of understanding the information given and sign informed consent
    E.4Principal exclusion criteria
    1. Other symptomatic lesions not under control
    2. Lesions not suitable for electrochemotherapy (bony invasion, large vessels infiltration, etc.)
    3. Acute lung infection
    4. Symptoms of poor lung function necessitates DLCO and patient can not be treated if this is abnormal
    5. Severe coagulation disorders not correctable
    6. Previous allergic reactions to bleomycin
    7. If cumulative dose of 240000 IU BLM/m2 was previously exceeded
    8. Chronic renal dysfunction (creatinine > 150 µmol/L)
    9. Pregnancy or lactation
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is to evaluate tumour response in the treated target lesion. This is
    achieved by CT and MRI imaging where the size of the tumour is measured by set criteria (RECIST criteria, version 1.1 - Response Evaluation Criteria In Solid Tumors).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The patients are scanned before treatment, 4 and 8 weeks after treatment and 4,8 and 12 months after treatment.
    The scanning performed 8 weeks after treatment will be the first evaluation-scan.

    If the tumor progresses, the patient will not be evaluated further. If the tumor is stable or reduce in size the patient will be followed and evaluated until 12 months after treatment.
    E.5.2Secondary end point(s)
    Secondary endpoints are:

    • Evaluation of PET-response in the tumour before and after treatment.

    • Evaluation of cellular response before and after treatment.

    • Evaluation of how well MRI imaging visualises the treated tumour site.

    • Recording of side effects to the treatment.

    • Recording of pain score and consumption of analgesics.

    • Evaluation of quality of life through questionnaires before and after treatment.

    • Recording of total and progression free survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Image modalities can be evaluated 4 weeks, 8 weeks, 4,8 and 12 months after treatment.

    Biopsies (cellular response) are performed during treatment, 7 and 35 days after treatment.

    The patient is examined, side effects, pain score, consumption of analgesics and "quality of life"-questionnaire are recorded in the first 3 days after treatment during hospitalization, and in outpatient visits 7, 14, 35 and 63 days after treatment and at 3, 4, 5, 6, 8, 10 and 12 months after treatment.

    Progression free and total survival will be followed during the year each patient is examined and afterwards the patients will be routinely examined once each year.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    phase II, non-comparative, observatory study
    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 No
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 29
    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 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 state29
    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)
    The patients, ending participation in the trial, continues treatment and follow up in our oncological departments as described in the danish guidelines for Head and Neck Cancer (DAHANCA).
    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 Decision2013-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-16
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