A Phase 1/2 Study of Pegylated Arginine Deiminase (ADI-PEG 20) Plus Radiotherapy (RT) and Temozolomide (TMZ) in Children, Adolescents, and Young Adults With Newly Diagnosed High-grade Glioma (HGG)
Sabine Mueller, MD, PhD
Summary
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).
Description
PRIMARY OBJECTIVES: I. To evaluate the safety and estimate the RP2D of ADI-PEG 20 in combination with RT and TMZ in with children, adolescents, and young adults with newly diagnosed high-grade glioma, and the RP2D of ADI-PEG 20 during maintenance therapy with TMZ (Phase 1) II. To assess the anti-tumor activity of the combination of ADI-PEG 20 with RT and TMZ based on progression-free survival (PFS) at 12 months for HGG histone-WT participants, 12 months for H3K27 altered DMG, and 10 months for H3G34 mutant DHG in children, adolescents, and young adult participants (Phase 2) EXPLORATORY OBJE…
Eligibility
- Age range
- 3–39 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have histologically and molecularly confirmed newly diagnosed World Health Organization (WHO) grade 3 or 4 glioma. 1. Phase 1: any newly diagnosed HGG (including DMG of any location and primary spinal cord tumors). 2. Phase 2: * 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). * Cohort 3: Newly diagnosed non-pontine, non-spinal cord H3G34 mutant diffuse hemispheric glioma (DHG). 2. Prior surgery: mus…
Interventions
- DrugADI-PEG 20 (Arginine deiminase pegylated)
Given intramuscularly (IM)
- DrugTemozolomide (TMZ)
Given orally (PO)
- RadiationStandard of Care Radiation Therapy (RT)
Undergo RT
Location
- University of California, San FranciscoSan Francisco, California