Stratum C (n=6-12) for Diffuse Intrinsic Pontine Glioma

Sydney Children's Hospital, Randwick, Australia
Diffuse Intrinsic Pontine Glioma+12 More ConditionsRibociclib - Drug
Eligibility
12 - 30
All Sexes
What conditions do you have?
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Study Summary

This trial will test if a combo of drugs can help extend life for pediatric and young adult patients with HGG, like DIPG.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma (DIPG)
  • Diffuse Intrinsic Pontine Glioma
  • Metastatic Brain Tumors
  • Grade III Glioma
  • Brain Tumor
  • Glioblastoma
  • Anaplastic Astrocytoma
  • Diffuse Midline Glioma, H3 K27M-Mutant

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

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

Day 28
Evaluate Health-Related Quality of Life Outcomes
Day 28
Establish MTD and RP2D of ribociclib and everolimus
Day 30
Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0
Objective Response Rate (ORR) in DIPG
Objective Response Rate (ORR) in HGG
Month 60
Progression-Free Survival (PFS) in HGG
Month 60
Overall Survival (OS) in DIPG
Overall Survival in HGG

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

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

Experimental Treatment

100 Total Participants · 4 Treatment Groups

Primary Treatment: Stratum C (n=6-12) · No Placebo Group · Phase 2

Stratum C (n=6-12)Experimental Group · 2 Interventions: Ribociclib, Everolimus · Intervention Types: Drug, Drug
Stratum A (n=40)Experimental Group · 2 Interventions: Ribociclib, Everolimus · Intervention Types: Drug, Drug
Stratum B (n=40)Experimental Group · 2 Interventions: Ribociclib, Everolimus · Intervention Types: Drug, Drug
Stratum D (n=6-12)Experimental Group · 2 Interventions: Ribociclib, Everolimus · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~9090
Everolimus
2010
Completed Phase 4
~1500

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor
317 Previous Clinical Trials
5,216,592 Total Patients Enrolled
4 Trials studying Diffuse Intrinsic Pontine Glioma
649 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
NovartisIndustry Sponsor
1,592 Previous Clinical Trials
2,705,219 Total Patients Enrolled
2 Trials studying Diffuse Intrinsic Pontine Glioma
30 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Margot Lazow, MDStudy ChairNationwide Children's Hospital
2 Previous Clinical Trials
514 Total Patients Enrolled
2 Trials studying Diffuse Intrinsic Pontine Glioma
514 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Maryam Fouladi, MDPrincipal InvestigatorNationwide Children's Hospital
8 Previous Clinical Trials
2,275 Total Patients Enrolled
5 Trials studying Diffuse Intrinsic Pontine Glioma
2,161 Patients Enrolled for Diffuse Intrinsic Pontine Glioma

Eligibility Criteria

Age 12 - 30 · All Participants · 10 Total Inclusion Criteria

Mark “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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.