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    Summary
    EudraCT Number:2007-000128-42
    Sponsor's Protocol Code Number:HIT-HGG-2007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000128-42
    A.3Full title of the trial
    International cooperative Phase II trial of the HIT-HGG study group for the treatment of high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children ≥ 3 years and adolescents < 18 years.
    A.3.2Name or abbreviated title of the trial where available
    HIT-HGG-2007
    A.4.1Sponsor's protocol code numberHIT-HGG-2007
    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 SponsorMartin-Luther-University Halle-Wittenberg
    B.1.3.4CountryGermany
    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 organisationUniversitätsmedizin Göttingen
    B.5.2Functional name of contact pointHIT-HGG-Studienzentrale
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Koch-Str. 40
    B.5.3.2Town/ cityGöttingen
    B.5.3.3Post code37075
    B.5.3.4CountryGermany
    B.5.4Telephone number004955139 66201
    B.5.5Fax number004955139 66231
    B.5.6E-mailchristof.kramm@med.uni-goettingen.de
    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 Temodal
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough Europe
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTemozolomide
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    Enteral use (Noncurrent)
    Nasogastric use (Noncurrent)
    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 Yes
    D.3.11.13.1Other medicinal product typeanti-neoplastic chemotherapeutic drug
    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
    1st line therapy of newly diagnosed, previously untreated high grade glioma, diffuse intrinsic pontine glioma, and gliomatosis cerebri in children and adolescents ≥ 3 years and < 18 years
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10002224
    E.1.2Term Anaplastic astrocytoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10030288
    E.1.2Term Oligodendroglioma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10066254
    E.1.2Term Gliomatosis cerebri
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10026659
    E.1.2Term Malignant oligodendroglioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10018340
    E.1.2Term Gliosarcoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10065443
    E.1.2Term Malignant glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10006143
    E.1.2Term Brain stem glioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10060971
    E.1.2Term Astrocytoma malignant
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10017701
    E.1.2Term Ganglioglioma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10003572
    E.1.2Term Astrocytoma malignant NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10018337
    E.1.2Term Glioblastoma multiforme
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10008093
    E.1.2Term Cerebral astrocytoma, high grade
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is treatment with temozolomide efficacious? Treatment is considered to be efficacious if the probability for “no event within the first 6 months after diagnosis” is not markedly inferior in comparison with the corresponding 6-months EFS-rates of the historical control group which was defined from patients of cohorts HIT-GBM-C and –D. That means that the probability for “no event within the first 6 months after diagnosis” is not ≤ 46% for patients with a pontine tumour and not ≤ 53% for patients with a non-pontine tumour. (6-months EFS-rates of historical control group from HIT-GBM-C+D were: 51% for patients with a pontine tumour, 58% for patients with a non-pontine tumour).
    E.2.2Secondary objectives of the trial
    1.Do the overall survival (OS) and event-free survival (EFS) of patients of the HIT-HGG-2008 trial differ from the OS / EFS of patients of the historical control groups (HIT-GBM-C and -D)?
    2. Does the HIT-HGG-2008 treatment lead to different toxicity rates in comparison to the historical control group (HIT-GBM-C and -D)?
    3. Has the methylation of the O6-MGMT gene promoter within the primary tumour an influence on the EFS?
    4. Do the clinical parameters (tumour location (ICDO classification), tumour grading and centrally reviewed histology, extent of tumour resection, genetic syndromes, secondary malignancies, age at diagnosis, gender, and relapse treatment within HIT-HGG-2008) have an influence on EFS or OS?
    5. Is there an association between these clinical parameters and the affiliation to one of the two patient groups HIT-HGG-2008 and HIT-GBM-C/-D?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Newly diagnosed, previously untreated high grade glioma with central neuropathological review including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic mixed glioma/anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV)

    •Newly diagnosed, previously untreated diffuse intrinsic pontine glioma of all tumour grades or without histology when confirmed by central neuroradiological review

    •Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuropathological review and neuroradiological review

    •Patient aged 3 years and older but under 18 years at time of diagnosis

    •Written informed consent of the patient and/or the patient’s parents or legal guardian according to national laws
    E.4Principal exclusion criteria
    •Pre-treatment differing from study protocol

    •Known hypersensitivity or contraindication to study drugs and/or dacarbazine

    •Prior chemotherapy or radiotherapy which prevents adequate performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary malignant glioma after a previous malignant brain tumour, e.g. medulloblastoma, supratentorial PNET. If previous treatment does not prevent the adequate performance of the outlined treatment protocol patients with secondary malignant glioma will be eligible for the present trial.

    •Other (simultaneous) malignancies

    •Pregnancy and / or lactation

    •Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)

    •Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial

    •Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)

    •Severe concomitant diseases (e.g. immune deficiency syndrome)

    •Known HIV positivity

    •Country-specifically very young patients may be excluded to comply with national laws or formal insurance requirements
    E.5 End points
    E.5.1Primary end point(s)
    Event-status 6 months after diagnosis: event / no event (i.e. by magnetic resonance imaging). An “event” is defined as

    •progression/relapse of disease
    •diagnosis of a secondary malignancy
    •death of any cause.

    We assume that each patient will be observed at least 6 months after diagnosis.
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life. establishment of network for routine native tumour sampling
    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 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
    historical control group: patients from HIT-GBM-C and –D
    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
    historical control group: patients from HIT-GBM-C and –D
    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 concerned60
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Scheduled to start on June 1, 2009. Recruitment period for interim
    analysis of the first stage last 24 months (May 31, 2011). Patient
    recruitment will continue for 70 more months till
    March 31, 2017. Sample size and duration of recruitment period of the
    whole trial was determined after the interim analysis.
    Individual follow-up for at least 2 years after study entry is required for
    this protocol, i.e. end of study will be June 30, 2019.
    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 months1
    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 months1
    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 Yes
    F.1.1Number of subjects for this age range: 456
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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
    Children under the age of 16 incapable of giving consent personally parents/guardians will give informed consent on behalf of these subjects.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state456
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 456
    F.4.2.2In the whole clinical trial 456
    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 participation in the trial of any subjects ends by the time of 2 years after the start of treatment. This includes treatment (one year) and the follow-up period. Thereafter, it is recommended that the patient will be followed by a certified paediatric oncology centre.
    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 Decision2008-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-30
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