Actively Recruiting
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
Led by Nationwide Children's Hospital · Updated on 2026-04-22
120
Participants Needed
21
Research Sites
522 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 months to 39 years at enrollment
- For initial ribociclib and everolimus feasibility cohort: patients under 21 years
- Newly diagnosed high-grade glioma (HGG) including DIPG confirmed by biopsy or resection
- DIPG tumors with pontine epicenter involving at least two-thirds of the pons, WHO grade 2-4 glioma
- Other HGG tumors must be WHO grade 3 or 4
- Patients with localized, metastatic, multifocal, spinal cord, or radiation-related HGG are eligible
- Presence of at least one actionable genetic alteration activating cell cycle or PI3K/mTOR pathways
- For DHG, H3G34-mutant patients, must have H3G34 (R/V) mutation
- Karnofsky (≥50%) or Lansky (≥50%) performance status depending on age
- Prior surgery, radiation therapy, and dexamethasone allowed; temozolomide with RT allowed
- Radiation therapy started within 42 days of diagnosis, standard dosing per protocol
- Treatment must start between 28 and 35 days after completing radiation therapy
- Adequate bone marrow, renal, liver, cardiac, neurologic, and pulmonary function
- Ability to take medications orally (no feeding tubes for ribociclib and everolimus strata)
- Signed informed consent and assent as appropriate
- Willingness to use effective contraception if of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unwilling or unable to use effective contraception during and for 3 months after treatment
- Receiving other investigational drugs or anti-cancer agents (except temozolomide with RT)
- Taking strong CYP3A4/5 inducers or inhibitors, or medications that prolong QTc interval
- Receiving therapeutic anticoagulation with warfarin or coumadin derivatives
- Uncontrolled infections
- Inability to comply with safety monitoring
- Active malabsorption syndrome or conditions affecting drug absorption
- Significant medical or psychiatric conditions affecting safety or study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
5
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Duke University Health System
Durham, North Carolina, United States, 27708
Actively Recruiting
7
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
8
Nationwide Children's Hospital
Columbus, Ohio, United States, 43235
Actively Recruiting
9
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
10
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
11
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
12
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
13
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
14
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
Actively Recruiting
15
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
16
The Hospital for Sick Children (SickKids)
Toronto, Ontario, Canada, M5G1X8
Not Yet Recruiting
17
Montreal Children's Hospital
Montreal, Quebec, Canada, H4A3J1
Not Yet Recruiting
18
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Not Yet Recruiting
19
Princess Máxima Center
Utrecht, Netherlands, 3720
Not Yet Recruiting
20
Starship Children's Hospital
Auckland, Grafton, New Zealand, 1023
Not Yet Recruiting
21
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Not Yet Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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