Purpose of this Study
We are doing this study to find out if the combination of an experimental drug called ONC201 (the study drug) with paxalisib is an effective option for patients with a diffuse midline glioma (DMG). We also want to see how much of these drugs are absorbed by tumor tissue in patients with brain tumors.
Who Can Participate?
Eligibility
Children and adults ages 2-39 who are diagnosed with DMG and:
- Have not started treatment yet; OR
- Have finished radiation therapy and have no evidence of progression; OR
- Have finished a full round of standard therapy and show evidence of progression
Age Range
2-39
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will go through a study screening period that lasts about 14 days and includes:
- Physical exams
- Blood draws and a urine sample
- An Imaging scan (MRI)
- A lumbar puncture (spinal tap)
- An electrocardiogram (ECG) and echocardiogram (ECHO)
- Physical exams
- Blood draws
- Stool samples
- Imaging scans (MRI)
- Heart scans (ECG)
- Questionnaires
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
PNOC022: A Combination Therapy Trial using an Adaptive Platform Design for Children and Young Adults with Diffuse Midline Gliomas (DMGs) including Diffuse Intrinsic Pontine Gliomas (DIPGs) at Initial Diagnosis, Post-Radiation Therapy and at Time of Progression
Principal Investigator
Daniel
Landi
Protocol Number
PRO00110922
NCT ID
NCT05009992
Phase
II/III
Enrollment Status
Open to Enrollment