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 version: 19.1 Level: PT Classification code 10002224 Term: Anaplastic astrocytoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1
Conditions
Interventions
Trade Name: Temodal
Product Name: Temozolomide
Pharmaceutical Form: Capsule, hard
Sponsors
Martin-Luther-University Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 456 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).; Secondary Objective: 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? ; Primary 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 | — |
Countries
Austria, Germany
Contacts
Public ContactHIT-HGG-Studienzentrale
Universitätsmedizin Göttingen
Outcome results
None listed