This is an open label, intra-patient dose escalation, to evaluate ADI-PEG 20, in combination with Temozolomide (TMZ) and radiation therapy (RT) in children, adolescents and young adult patients with newly diagnosed high grade glioma (HGG).
Participants must have histologically and molecularly confirmed newly diagnosed World Health Organization (WHO) grade 3 or 4 glioma.
Phase 1: any newly diagnosed HGG (including DMG of any location and primary spinal cord tumors).
Cohort 1: Newly diagnosed non-pontine, non-spinal cord HGG histone-wildtype.
Cohort 2: Newly diagnosed non-pontine, non-spinal cord H3K27 altered diffuse midline glioma (DMG).
Participants who have received any systemic therapy or RT, including any investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20 such as pegylated compounds.
Phase 2 cohorts: tumors with epicenter in pons or spinal cord
Participants with metastatic or leptomeningeal disease. Multi-focal disease should be discussed with the study chairs,
Sabine Mueller, MD, PhD
Lead sponsor
University of California, San Francisco
Sponsor institution