HIT-HGG-2007

автор: Julia Dobke, HIT HGG 2007 Studie, erstellt am: 2010/03/19, Последнее изменение: 2019/03/13

HIT-HGG-2007 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.
Формы рака First line treatment of high grade gliomas, diffuse intrinsic pontine glioma, and gliomatosis cerebri in paediatric patients ≥ 3 years and <18 years of age.
Вид исследования Multinational, prospective, non-randomized phase II trial concerning treatment efficacy and toxicity in regards to the subsequent initiation of a phase III trial.
Цель исследования

Based on the positive results of the EORTC-Trial with adult patients with a Glioblastoma, who were treated with oral Temozolomide and radiotherapy (Stupp et al. 2005), a clinical Phase-II-trial with oral Temozolomide and radiotherapy,followed by consolidation chemotherapy will be carried out.
The trial includes patients >= 3 years and < 18 years with a new diagnozed and not treated high grade Glioblastoma, diffuse intrinsic pontine glioma or Gliomatosis cerebri. The aim of this trial is the survey, if the parameter "6 month event-free-survival (EFS)" will support the initiation of a phase- III- trial within the same group of patients.
The 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.
It will be the aim of the the phase-III-trial to verify the results of the phase-II-trial with temozomolide and radiotherapy regarding the long time event-free survival and the efficacy of an additional randomized Immunotherapy element.

Лечение

All participants will be treated in the same study-arm. The treatment starts with surgery. The primary objective for tumour surgery is to resect as much tumour tissue as possible since the extent of tumour resection.
For planning of the radiotherapy, the precise extent of tumour disease must be known, and, therefore, pre- and postsurgical MRI should be available. Temozolomide chemotherapy will start at the first day of radiotherapy and will end at the last day of radiotherapy. It will be given as one single daily dose of [75 mg/m2/d] during the whole duration of radiotherapy including radiotherapy-free days, i.e. on weekend days, holidays etc., but not longer than for 49 continuous days.
Maintenance chemotherapy with temozolomide will start at earliest 4 weeks after the end of radiochemotherapy. It will be given as one single daily dose of [150-200 mg/m2/d] on days 1 to 5, repeated every 28 days for up to 12 cycles.

Кого берут в протокол
  • 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
  • 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
Кого не берут в протокол
  • Pre-treatment of 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), gliosarcoma (WHO IV), diffuse intrinsic pontine glioma and gliomatosis cerebri 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, condoms)
  • 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
Сколько пациентов должно пройти через исследование Multinational, prospective, non-randomized phase II trial concerning treatment efficacy and toxicity in regards to the subsequent initiation of a phase III trial.
Status 1. Recruitment: 01.07.2009-28.02.1011; Interim analysis: 08/2011, 2. Recruitment: 01.03.2011- 29.02.2012; Final analysis: 09/2012
EudraCT 2007-000128-42
Entry Study Register
Руководитель протокола Prof. Dr. med. Christof Kramm
E-Mail hit-hgg-studie@med.uni-goettingen.de
С кем можно связаться

Principal Investigator

Prof. Dr. med. Christof Kramm Klinik- für Kinder- und Jugendmedizin Leiter Abteilung Pädiatrische Hämatologie/Onkologie Robert-Koch-Str. 40 37075 Göttingen Telefon +49 551/39-63080/63081 Fax +49 551/39 63083 christof.kramm@med.uni-goettingen.de

Study coordination

Dr. rer. nat. Marion Hoffmann Universitätsmedizin Göttingen Klinik für Kinder und Jugendmedizin, Pädiatrische Onkologie und Hämatologie Robert-Koch-Str. 40 37075 Göttingen Telefon +49 (551) 39 63085 Fax +49 (551) 39 63083 mhoffmann@med.uni-goettingen.de

Documentation

Denise Lauerer UMG Universitätsmedizin Göttingen HIT-HGG-Studienzentrale Robert-Koch-Str. 40 37075 Göttingen Telefon +49 (551) 39 20 632 denise.lauerer@med.uni-goettingen.de

Reference pathology

Prof. Dr. med. Torsten Pietsch Institut für Neuropathologie ME der Universität Sigmund-Freud-Str. 25 53105 Bonn Telefon +49 (228) 287 16602 Fax +49 (228) 287 14331 t.pietsch@uni-bonn.de

National Coordinator Austria

Univ. Prof. Dr. med. Martin Benesch Universitätsklinik für Kinder- und Jugendheilkunde Abt. Pädiatrische Hämatologie/Onkologie Auenbruggerplatz 30 A 8010 Graz Telefon +43-316-385-80427 Fax +43-316-385-3450 martin.benesch@klinikum-graz.at

National Coordinator Swizzerland

Dr. med. Nicolas Gerber Kinderspital Zürich Onkologie Steinwiesstr. 75 8032 Zürich Telefon +41 (044) 266 74 55 Fax +41 (044) 266 78 34 nicolas.gerber@kispi.uzh.ch

Участники исследования GPOH, Österreich, Schweiz
Кто финансирует Deutsche Kinderkrebsstiftung