TarGeT-A: Phase 2 Study of Ribociclib and Everolimus Following Radiotherapy in Pediatric and Young Adult Patients Newly Diagnosed with High-Grade Glioma (HGG), including Diffuse Intrinsic Pontine Glioma (DIPG), which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways
Primary Investigator
Upadhyaya, Santhosh
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT05843253
UM Number
2025.041
Age Group
Children
Management Group
CTSU - Michigan
Oncology Group
Childhood Cancers
ID (Protocol)
59807
Secondary Protocol No
HUM00272106
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Brain and Nervous System
Summary
The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target or 2) ribociclib and temozolomide to treat pediatric and young adult patients newly diagnosed with diffuse hemispheric glioma (DHG), H3G34-mutant.
The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.
The main question the study aims to answer is whether the combinations of ribociclib and everolimus or ribociclib and temozolomide can prolong the life of patients diagnosed with HGG/DIPG or DHG H3G34-mutant.
Eligibility:
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