Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant (NCT05843253)
Phase 2 Study of Ribociclib-Containing Post-Radiotherapy Combinations in Pediatric and Young Adult Patients Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma: Ribociclib and Everolimus for HGG/DIPG Which Harbor Alterations of the Cell Cycle and/or PI3K/mTOR Pathways AND Ribociclib and Temozolomide for DHG, H3G34-mutant
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital Colorado — Aurora, Colorado
Age range: 12 Months to 39 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (20 Sites)
- Children's Hospital Colorado — Aurora, Colorado
- Children's National Medical Center — Washington D.C., District of Columbia
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Dana-Farber Cancer Institute — Boston, Massachusetts
- C.S. Mott Children's Hospital — Ann Arbor, Michigan
- Duke University Health System — Durham, North Carolina
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Texas Children's Hospital — Houston, Texas
- Seattle Children's Hospital — Seattle, Washington
- Sydney Children's Hospital — Randwick, New South Wales
- Queensland Children's Hospital — South Brisbane, Queensland
- Royal Children's Hospital — Melbourne, Victoria
- Perth Children's Hospital — Perth, Western Australia
- The Hospital for Sick Children (SickKids) — Toronto, Ontario
- Montreal Children's Hospital — Montreal, Quebec
- Hopp Children's Cancer Center at NCT Heidelberg (KiTZ) — Heidelberg, Baden-Wurttemberg
- Starship Children's Hospital — Auckland, Grafton
- Great Ormond Street Hospital — London,
📞 Contact the Study Coordinator
Phone: (614) 722-3284
Email: kelsey.troyer@nationwidechildrens.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in High Grade Glioma
- Study of DSP-0390 in Patients With Recurrent High-Grade Glioma — San Francisco, California
- Circulating Tumor DNA Collection From Patients With High Grade Gliomas — Toronto, Ontario
- A Phase 1b Study of PTC596 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma and High Grade Glioma — Aurora, Colorado
- PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma — Aurora, Colorado
- Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors — Aurora, Colorado
- MRI in High-Grade Glioma Patients Undergoing Chemoradiation — Winston-Salem, North Carolina
Explore by condition: All High Grade Glioma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.