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International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)

NCT03243461 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2022-06-06

No results posted yet for this study

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).

In the present study, it was originally planned to investigate the therapeutic efficiency and safety of valproic acid and the autophagy inhibitor chloroquine, both in addition to temozolomide therapy. Since distribution of Resochin junior (chloroquine phosphate) was terminated, recruitment of new patients was stopped on August 8, 2019. For continuation of the trial, the chloroquine arm was closed but the patients already recruited in this arm will be followed up.

Conditions

  • Glioblastoma WHO Grade IV
  • Diffuse Midline Glioma Histone 3 K27M WHO Grade IV
  • Anaplastic Astrocytoma WHO Grade III
  • Diffuse Intrinsic Pontine Glioma
  • Gliomatosis Cerebri

Interventions

DRUG

Temozolomide + Valproic Acid

Valproic acid additionally to simultaneous radiochemotherapy with temozolomide

Sponsors & Collaborators

  • Deutsche Kinderkrebsstiftung

    collaborator OTHER

  • Hannover Medical School

    collaborator OTHER

  • University of Göttingen

    lead OTHER

Principal Investigators

  • Christof Kramm, Prof., MD · University of Göttingen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-17
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243461 on ClinicalTrials.gov