PNOC023: Open label Phase 1 and Target Validation study of ONC206 in Children and Young Adults with Newly Diagnosed or Recurrent Diffuse Midline Glioma (DMG), and Other Recurrent Primary Malignant Central Nervous System (CNS) Tumors
Primary Investigator
Koschmann, Carl
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT04732065
UM Number
2021.047
Age Group
Children
Management Group
CTSU - Michigan
Oncology Group
Childhood Cancers
ID (Protocol)
29878
Secondary Protocol No
HUM00193644
Scope
National
Sponsor Type
Industry
Disease Site
Brain and Nervous System
Summary
This phase I trial studies the effects and best dose of ONC206 alone or in combination with radiation therapy in treating patients with diffuse midline gliomas that is newly diagnosed or has come back (recurrent) or other recurrent primary malignant CNS tumors. ONC206 is a recently discovered compound that may stop cancer cells from growing. This drug has been shown in laboratory experiments to kill brain tumor cells by causing a so called "stress response" in tumor cells. This stress response causes cancer cells to die, but without affecting normal cells. ONC206 alone or in combination with radiation therapy may be effective in treating newly diagnosed or recurrent diffuse midline gliomas and other recurrent primary malignant CNS tumors.
Eligibility:
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