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    Summary
    EudraCT Number:2010-023356-90
    Sponsor's Protocol Code Number:1020
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-30
    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 number2010-023356-90
    A.3Full title of the trial
    Electrochemotherapy as a palliative treatment for brain metastases
    A.4.1Sponsor's protocol code number1020
    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 SponsorOncology Department
    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 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 Bleomycin "Baxter"
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter A/S, Gydevang 43, 3450 Allerød
    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.3.1Product namebleomycin "Baxter"
    D.3.4Pharmaceutical form Powder for infusion*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntratumoral use
    Intravenous use
    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
    Patient with brain metastases from cancer of any histology. A phase I trial.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10006128
    E.1.2Term Brain metastases
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary endpoint is safety of the trial treatment, electrochemotherapy for brain metastases. This is evaluated by regularly registrations of adverse events (serious adverse events and adverse events) using the CTCAE criteria version 4.0.
    E.2.2Secondary objectives of the trial
    The secondary endpoint is efficacy of the trial treatment, electrochemoterapy for brain metastases. This is evaluated by tumor response on MRI scans of the brain using the RECIST criteria.

    Performance in basic Activities of Daily Living (ADL) measured by the Barthel Index.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients > 18 years.
    2. ECOG performance status < 2.
    3. Diagnosis of brain metastases originated from histological or cytological verified cancer of any histology.
    4. Patients should have received whole-brain radiation therapy (WBRT) with a time interval of at least 2 months from completion of WBRT until inclusion in this study.
    5. Patients must have been offered every available standard treatment. If there is no more standard treatment available or if a patient does not wish to receive the standard treatment, the patient can be included in this study.
    6. Endocrine anti-cancer treatment may be continued if the patient can benefit from this treatment i.e. obtain or gain control of the cancer outside the brain.
    7. Ongoing chemotherapy that has had no effect on the present brain metastases may be continued. However, no chemotherapy should be given 3 weeks prior to and 2 weeks after treatment with electrochemotherapy.
    8. Patients can be initiated on chemotherapy during this study as long as the treatment has no documented effect on brain metastases.
    9. Local surgery or radiotherapy of a palliative nature and with no documented effect on brain metastases can be performed during the study.
    10. Brain metastases to be treated must be > 10 millimetre and < 27 millimetre.
    11. Brain metastases to be treated must be accessible for treatment. This assessment is performed by a neurosurgeon using a MRI scan of the brain.
    12. Patients may have more brain metastases than are being treated.
    13. Estimated remaining life time must be more than 3 months.
    14. Patients must have adequate organ functions:
    o Adequate bone marrow reserve: Leucocytes (WBC) > 3.0 x 109/l, thrombocytes > 75 x 109/l, hemoglobin > 7 g/dl.
    o Hepatic: Alkaline phosphate, ALAT or ASAT and bilirubin must not be increased more than 2 times, pp > 40, APTT in normal range. Medical correction is allowed, e.g. correction of low pp using vitamin K.
    o Renal: if creatinin > 150 micromolar do a GFR examination (Chrom-EDTA). If Chrom-EDTA clearance is less than 48 ml/min, treatment cannot be offered
    15. Patients must not have a blood pressure (BP) over 180 mm Hg systolic and 110 mm Hg diastolic. In the case of BP>180/110 mm Hg, this can be medically corrected, and the patient can be included, when the BP is below this threshold.
    16. Sexually active men and women of childbearing potential must use adequate birth control during this study and 6 month after the administration of bleomycin (contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches).
    17. Participating patients must be able to understand the patient information (‘Deltagerinformation’).
    18. Participating patients must have signed a written informed consent and power of attorney prior to inclusion in this study.
    E.4Principal exclusion criteria
    1. Acute lung infection.
    2. Previous bleomycin treatment with more than 200.000 Units/m2.
    3. Previous allergic reaction to bleomycin.
    4. Allergy towards the sedation used.
    5. Pregnancy or breastfeeding. Pregnancy in fertile women is excluded by a measurement of HCG in a blood sample. Sterile or infertile women are excluded from the requirement to use anticonception. To be considered sterile or infertile, the patient must have undergone surgical sterilization (vasectomy/bilateral tubectomy, hysterectomy and bilateral ovarectomy) or be post-menopausal defined as the absence of menstruation.
    6. Treatment with G-CSF (Granulocyte Colony Stimulating Factor) or other cytokines.
    7. Lung diffusion capacity (DLCO) below normal. DLCO is to be performed in case of suspected (anamnestic or clinical) reduced lung function.
    8. Physician’s assessment that meningeal carcinomatosis (leptomeningeal disease) is a likely cause of the patient’s symptoms.
    9. Treatment with anticoagulants (marevan, marcumar, innohep). If the physician finds it safe to pause the administration of anticoagulants the patient can be included. This decision should be made using the Neurosurgery Department’s Guideline.
    10. Allergic to nickel, chromium or cobalt.
    11. Participation in another clinical study with an experimental drug up to 4 weeks prior to inclusion.
    12. Illnesses, medical, social or physiological, that may affect the patient’s ability to understand the patient information and participate in the follow-up.
    13. Other serious systemic illnesses (i.e. active infection, abnormal EKG) that the investigator finds may affect the patient’s safety and/or ability to complete the study.
    14. Treatment with Immunosuppressant drugs such as methotrexat and cyclosporine during the study. Treatment with prednisolone is accepted during the study.
    15. Implanted pacemaker, defibrillators or hearth valve prosthetics.
    16. Implanted devices such as neurostimulators, eartransplants, insulinpump, metallic tracheostomy.
    17. Catheters with metal such as Port á cath, Swan Ganz, P-dialysis cath., ventriculoartrial and -peritoenal shunts, bladder cath. with thermo measurement.
    18. Metallic clips/prosthetics/magnets from surgery such as neuro- or abdominal clips, tooth- or other prosthetics.
    19. Disorganised metallic material such as metal fragments in the eyes, shrapnel, gun shot injuries.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this dose-escalating fase I clinical trial is safety of the trial treatment. This is evaluated by regularly registrations of adverse events (Serious Adverse Events and Adverse Events) using the CTCAE criteria version 4.0. Determination of dose limiting toxicity (DLT) is defined as any CTCAE grade 4 toxicity.
    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 Yes
    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 Yes
    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
    From the 1 st inclusion untill the last visit of the last subject
    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
    E.8.9.2In all countries concerned by the trial years0
    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.1.3Elderly (>=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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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 Decision2011-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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