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Klinische Studien

HIT-HGG-2007

AcronymISRCTNEudraCTClinicaltrials.govDRKS
HIT-HGG-2007ISRCTN198524532007-000128-42

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.

Status: Active

Purpose / Objectives

Primary Outcome

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 inferior in comparison
with the corresponding 6-months EFS rates of the HIT-GBM-C
and —D cohort. That means that the probability for “no event
CONFIDENTIAL
HIT-HGG-2007 Final version, 2008-05-01 Page 14 of 160
within the first 6 months after diagnosis” is not ≤ 46% for patients
with a pontine tumour and not ≤ 53% for patients with a nonpontine
tumour. The probability for being event-free 6 months
after diagnosis is different for patients with and without a pontine
tumour.

Secondary Outcomes

Secondary objectives
1. Do the overall survival (OS) and event-free survival (EFS) of
patients of the HIT-HGG-2007 trial differ from the OS / EFS of
patients of the historical control groups (HIT-GBM-C and-D)?
2. Does the HIT-HGG-2007 treatment leads to different toxicity
rates in comparison to the historical control group (HIT-GBM-C
and -D)?
3. Has the methylation of the O6-MGMT (O6-methylguanine-DNA
methyltransferase) gene promoter within the primary tumour an
influence on the EFS? (similar to reports in adult patients with
glioblastoma (Hegi et al. 2005))
4. Do the following clinical parameters have an influence on EFS or
OS?
• tumour location (ICD-O classification)
• tumour grading
• centrally reviewed histology (WHO classification; Louis et al.
2007)
• extent of tumour resection (as defined by early post surgical
imaging, preferentially magnetic resonance imaging)
• genetic syndromes
• secondary malignancies
• age at diagnosis
• gender
• relapse treatment
5. Is there an association between these clinical parameters and
the affiliation to one of the two patient groups HIT-HGG-2007

Diagnosis

Patient attributes

Age

3-18

Inclusion criteria

• newly diagnosed, previously untreated, and by refe-renzhistologische examination confirmed high-grade gliomas including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligo-godendrogliom (WHO III), anaplastic Mischgliom / ana-plastic oligoastrocytoma (WHO III), anaplastic pi-lozytischem astrocytoma (WHO III), anaplastic Gan-gliogliom (WHO III), anaplastic pleomorphic Xanthoa-strozytom (WHO III), giant cell glioblastoma (WHO IV) and gliosarcoma (WHO IV) • newly diagnosed, previously untreated, and by referenzradiologische review secured diffusesintrinsisches Ponsgliom all WHO grade
• newly diagnosed, previously untreated, and by-referenced assessment renzneuropathologische secure glioma cerebral ptosis of WHO grade
• Patients age ≥ 3 and <18 years at diagnosis
• Written consent for study participation of the patient or his legal representative

Exclusion criteria

• From the study protocol different pretreatment a glioblastoma multiforme (WHO IV), analastischen Astrozy-toms (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic Mischglioms / anaplastic Oligoa-strozytoms (WHO III), anaplastic pleomorphic xanthoastrocytomas (WHO III), giant cell glioblastoma (WHO IV), gliosarcoma (WHO IV), and diffuse intrinsic Ponsglioms Gliomatosis cerebri
• Known allergy / hypersensitivity
Temozolomide and dacarbazine
• Previous chemotherapy or radiation, according to the protocol to participate in the implementation of radiotherapy according to HIT-HGG-2007 no longer erlakönnen patients with glioma grade or on the HIT-HGG-2007 study.
• Other (simultaneous) malignancy
• Pregnancy / breastfeeding
• Sexually active patients who refuse an effective contraception (eg oral contraception, condoms as contraceptives are not sufficient)
• Current or recent (ie within 30 days before start of treatment according to HIT-HGG-2007) treatment with study medication or participation in another treatment study
• Very bad general condition with clinical need for mechanical ventilation and / oderintravenöser Katecholamingabe and / or severe neurological damage comparable to a Komaoder tetraplegia and complete lifting of communication skills (deafness, blindness, and mutism)
• Severe concomitant disease (eg immune deficiency syndrome)
• Known HIV positivity

Trial design

  • Phase II
  • Multicenter

Documents (password protected)

Responsibilities in overall trial

Martin Luther Universität Halle/Wittenberg

    National Coordinating Investigator

    Prof. Dr. med. Christof Kramm

    Study Sites

    Klinik für Kinder-Onkologie, -Hämatologie und Immunologie

    Status

    Active

    Klinik und Poliklinik für Kinder- und Jugendmedizin

    Study office

    Status

    Active (Recruitment Closed)

    Principal Investigator

    Prof. Dr. med. Thorsten Simon

    Deputy of Principal Investigator

    • Prof. Dr. med. Matthias Fischer
    • Dr. med. Barbara Hero
    • Dr. med. Marc Hömberg
    • Dr. med. Pablo Landgraf

    Subinvestigator

    • Dr. med. Rita Kiener
    • Dr. med. Diana Dworaczek, geb. Gomez Alcazar

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