International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
The HIT-HGG-2013 trial offers an innovative high-quality diagnostics and science program for
children and adolescents >3 years, suffering from one of the following types of high grade
gliomas:
1. glioblastoma WHO grade IV (GBM)
2. diffuse midlineglioma histone 3 K27M mutated WHO grade IV (DMG)
3. anaplastic astrocytoma WHO grade III (AA)
4. diffuse intrinsic pontine glioma (DIPG)
5. gliomatosis cerebri (GC) For 1.-3. diagnosis has to be confirmed by neuropathological
survey, for 4. and 5. diagnosis has to be confirmed by neuroradiological survey.
In addition to standard treatment (radiotherapy and temozolomide chemotherapy) the effect of
valproic acid which is traditionally used for treatment of seizure disorder, will be
investigated. The aim of the trial will be to investigate whether this drug may increase the
effects of radio- and chemotherapy, resulting in a better survival of the treated patients.
Scientific studies provided evidence for anti-tumoral effects of valproic acid: the drug
seems to be a so-called histondeacetylase inhibitor (HDAC inhibitor), controlling important
genetic processes of tumor growth.
Studies in cell culture, animals and first clinical trials in adults as well provided
evidence for efficacy of valproic acid in the treatment of glioblastoma. Due to this we hope
children and adolescents suffering from GBM, DMG, AA, DIPG und GC will benefit from the
treatment, too.
The aim of the HIT-HGG-2013 trial will be to compare the effects of Valproic acid with data
of the HIT-HGG-2007 trial (children and adolescents with same diseases, only treated with
simultaneous temozolomide radiochemotherapy).
Phase:
Phase 3
Details
Lead Sponsor:
University of Göttingen
Collaborators:
Deutsche Kinderkrebsstiftung Hannover Clinical Trial Center GmbH Hannover Medical School