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
Primary Investigator
Koschmann, Carl
Status
OPEN TO ACCRUAL
Phase
II
NCT Number
NCT05009992
UM Number
2021.136
Age Group
Children
Management Group
CTSU - Michigan
Oncology Group
Childhood Cancers
ID (Protocol)
38403
Secondary Protocol No
HUM00208096
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Brain and Nervous System
Summary
This phase II trial determines if the combination of ONC201 with different drugs, panobinostat or paxalisib, is effective for treating patients with diffuse midline gliomas (DMGs). Despite years of research, little to no progress has been made to improve outcomes for patients with DMGs, and there are few treatment options. ONC201, panobinostat, and paxalisib are all enzyme inhibitors that may stop the growth of tumor cells by clocking some of the enzymes needed for cell growth. This phase II trial assesses different combinations of these drugs for the treatment of DMGs.
Eligibility:
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