A Window-of-opportunity Early Phase I Randomized Study of Neoadjuvant Chemoradiotherapy With or Without Concurrent Azeliragon in Patients With Newly Diagnosed Glioblastoma
Washington University School of Medicine
Summary
Preclinical data have demonstrated the combination of azeliragon, a RAGE inhibitor, with radiation therapy (RT) can effectively reduce immune-suppressive myeloid cells and restore T-cell activation to improve tumor control in murine glioma models. Ongoing clinical studies of azeliragon with RT alone and RT plus temozolomide (TMZ) to treat patients with newly diagnosed glioblastoma (GBM) have demonstrated safety and tolerability. The purpose of this window-of-opportunity study is to validate that the combination of azeliragon with RT and TMZ would modulate immune-suppressive myeloid and T cells in the tumor microenvironment in patients with GBM.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically proven diagnosis of IDH-wildtype GBM (WHO grade 4) according to the 2021 WHO classification (including subtypes such as gliosarcoma). * Radiographic evidence of residual tumor after initial surgery or biopsy. * Patient is amenable for future surgery (either surgical resection or laser interstitial thermal therapy (LITT)) to sample the residual tumor after completion of chemoradiotherapy. * At least 18 years of age. * Eligible for and planning to receive standard fractionated RT of 60 Gy with concurrent TMZ. * Recovered from the effects of surgery, postoper…
Interventions
- DrugAzeliragon
Provided by Cantex Pharmaceuticals
- DrugTemozolomide
Standard of care.
- RadiationRadiation therapy
Standard of care.
- ProcedureSurgery or LITT
Standard of care surgical resection or laser interstitial thermal therapy (LITT).
Location
- Washington University School of MedicineSt Louis, Missouri