ADI-PEG 20, Temozolomide, and Radiation for Newly Diagnosed High-Grade Glioma
This study is testing a combination of treatments for newly diagnosed high-grade glioma (a type of brain tumor) in children, adolescents, and young adults. The treatments include ADI-PEG 20 (arginine deiminase pegylated), Temozolomide (TMZ), and standard radiation therapy (RT). Researchers want to see how safe this combination is and how well it works to stop the tumor from growing. You could be eligible if you are between 3 and 39 years old and have a newly diagnosed high-grade glioma, including specific types like glioblastoma or diffuse midline glioma. The study will look at side effects and how long patients live without their disease getting worse.
- Study design
- This is an open-label study, meaning everyone knows which treatments are being given. It aims to enroll 97 participants and will evaluate the safety and effectiveness of the treatment combination.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 104 weeks to monitor side effects, and for up to 12 months to assess how long they live without the disease progressing.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Combination ADI-PEG 20, TMZ, and RT for Treatment of Newly Diagnosed High-grade Glioma (HGG)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Sabine Mueller, MD, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Tom Davidson, MD · STUDY_CHAIR · Children's Hospital Los Angeles
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Proportion of participants with Treatment-emergent Adverse Events (TrAE) (Phase 1)Up to 104 weeks
Proportion of participants in Phase 1 with treatment-emergent adverse events as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be reported.
- Progression-Free Survival (PFS) for HGG histone-WT (Phase 2, Cohort 1)Up to 12 months
PFS for participants in Phase 2, Cohort 1 is defined as the median number of days participants remained progression free at 12 months. Participants without a documented tumor progression or death will be censored on the date of their last evaluable tumor assessment. Participants without a documented tumor progression or death before initiation of another anti-tumor therapy will be censored on the date of their last evaluable tumor assessment prior to or on the date of the new anti-tumor therapy. PFS estimates will be obtained from the Kaplan-Meier curve. An appropriate variance term that accounts for censoring Greenwood's formula) will be used to construct the 95% confidence intervals.
- Progression-Free Survival (PFS) for H3K27 altered diffuse midline glioma (DMG) (Phase 2, Cohort 2)Up to 12 months
PFS for participants in Phase 2, Cohort 2 is defined as the median number of days participants remained progression free at 12 months. Participants without a documented tumor progression or death will be censored on the date of their last evaluable tumor assessment. Participants without a documented tumor progression or death before initiation of another anti-tumor therapy will be censored on the date of their last evaluable tumor assessment prior to or on the date of the new anti-tumor therapy. PFS estimates will be obtained from the Kaplan-Meier curve. An appropriate variance term that accounts for censoring Greenwood's formula) will be used to construct the 95% confidence intervals.
- Progression-Free Survival (PFS) for H3G34 mutant diffuse hemispheric glioma (DHG) (Phase 2, Cohort 3)Up to 10 months
PFS for participants in Phase 2, Cohort 3 is defined as the median number of days participants remained progression free at 10 months. Participants without a documented tumor progression or death will be censored on the date of their last evaluable tumor assessment. Participants without a documented tumor progression or death before initiation of another anti-tumor therapy will be censored on the date of their last evaluable tumor assessment prior to or on the date of the new anti-tumor therapy. PFS estimates will be obtained from the Kaplan-Meier curve. An appropriate variance term that accounts for censoring Greenwood's formula) will be used to construct the 95% confidence intervals.