Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant

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 diagno

Trial Details

NCT ID

NCT05843253

Phase

PHASE2

Sponsor

Nationwide Children's Hospital

Status

RECRUITING

Cancer Type

Glioblastoma (GBM) Brain Cancer

Locations (sample)

Aurora, Colorado, United States|39.72943,-104.83192
Washington D.C., District of Columbia, United States|38.89511,-77.03637
Chicago, Illinois, United States|41.85003,-87.65005
Boston, Massachusetts, United States|42.35843,-71.05977
Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility Criteria

Inclusion criteria already met to enroll on TarGeT-SCR (central molecular and histopathologic screening) based on:
1) Age: patients must be ≥12 months and ≤39 years of age at the time of enrollment on TarGeT-SCR. For the Part 1 Initial Feasibility Cohort (receiv…
2) Diagnosis: patients with newly-diagnosed HGG, including DIPG are eligible. All patients must have histologic confirmation tumor tissue from diag…
For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopatholo…

For full eligibility, visit ClinicalTrials.gov.

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