This trial will test if a combo of drugs can help extend life for pediatric and young adult patients with HGG, like DIPG.
- Diffuse Intrinsic Pontine Glioma (DIPG)
- Diffuse Intrinsic Pontine Glioma
- Metastatic Brain Tumors
- Grade III Glioma
- Brain Tumor
- Anaplastic Astrocytoma
- Diffuse Midline Glioma, H3 K27M-Mutant
3 Primary · 5 Secondary · Reporting Duration: From date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months
Awards & Highlights
4 Treatment Groups
Stratum C (n=6-12)
1 of 4
Stratum A (n=40)
1 of 4
Stratum B (n=40)
1 of 4
Stratum D (n=6-12)
1 of 4
100 Total Participants · 4 Treatment Groups
Primary Treatment: Stratum C (n=6-12) · No Placebo Group · Phase 2
Who is running the clinical trial?
Age 12 - 30 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
Is there an age cutoff for participation in this investigation?
"This trial has strict eligibility requirements, limiting participants aged between 12 months and 30 years old. Clinicaltrials.gov houses 155 studies for people under 18 while 708 are available to those over 65." - Anonymous Online Contributor
How many sites are currently engaging in this research?
"This trial is recruiting from 18 different medical centres, including the Children's National Medical Centre in Washington, Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago and Dana-Farber Cancer Institute in Boston, as well as 15 other sites." - Anonymous Online Contributor
Is recruitment ongoing for this research study?
"According to clinicaltrials.gov, the current state of this trial does not involve patient recruitment. While it was initially posted on August 15th 2023 and last updated on May 2nd 2023, there are 845 other medical studies currently accepting patients for enrolment." - Anonymous Online Contributor
Does Stratum A (n=40) have valid regulatory clearance?
"As this is a Phase 2 trial with some evidence of safety but none for efficacy, we have evaluated Stratum A (n=40) to be of moderate risk and assigned it a score of 2." - Anonymous Online Contributor
Could I feasibly partake in this experiment?
"This clinical trial requires participants to have glioblastoma and must be within the age bracket of 12 months until 30 years old. Approximately 100 people will be admitted." - Anonymous Online Contributor
What positive results are expected from this clinical investigation?
"The primary outcome for this research endeavour, spanning from the date of treatment to either Progressive Disease or death attributed to any cause and assessed up to 60 months later, is Overall Survival (OS) in DIPG. Assessing Objective Response Rates (ORR) in both HGG and DIPG as well as reporting Adverse Events associated with ribociclib and everolimus via CTCAE v5.0 also form Secondary outcomes for this study." - Anonymous Online Contributor