Diffuse Intrinsic Pontine Gliomas (DIPG)

This is a prospective, open-label, multicenter, phase III randomized controlled trial comparing intensity-modulated proton therapy (IMPT) with intensity-modulated radiation therapy (IMRT) in participants aged 3-18 years with newly diagnosed diffuse intrinsic pontine glioma (DIPG). Eligible participants will be randomly assigned in a 1:1 ratio to the IMPT group or the IMRT group. Both groups will receive concurrent and adjuvant temozolomide and standardized supportive care. The primary endpoint is the 1-year overall survival rate. Secondary endpoints include the 1-year progression-free survival rate, radiographic tumor response, treatment-related adverse events, neurological function, corticosteroid use, and quality of life. Exploratory analyses will evaluate potential tumor- and blood-based molecular and immune biomarkers. A total of 142 participants are planned to be enrolled. The study aims to compare the efficacy and safety of IMPT and IMRT in patients with newly diagnosed DIPG.

This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.

In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.