Phase 2 Study of Sitagliptin Treatment in Adults With Progressive Grade 4 Gliomas to Improve Immune Response

What this Trial Is About

Researchers are studying patients with progressive grade 4 gliomas, specifically glioblastoma, to see if the drug sitagliptin can enhance the immune systems response against the tumor. This study focuses on how sitagliptin might affect myeloid-derived suppressor cells MDSCs, which suppress the bodys natural defense against cancer. The trial builds on previous findings showing that reducing MDSCs may improve immune activity in glioblastoma patients. Participants will be divided into two groups one receiving sitagliptin before and after tumor surgery, and the other receiving sitagliptin only after surgery. Sitagliptin will be self-administered orally at varying doses 100 mg, 50 mg, or 25 mg daily. Following surgery, all participants will also receive chemotherapy until their disease progresses. The study is designed as a randomized, phase 2 trial to investigate the safety and biological impact of sitagliptin treatment. During the study, participants will undergo tumor surgery and receive sitagliptin treatment. Researchers will measure immune cell levels in the tumor tissue and track survival rates and disease progression. Safety will be monitored by recording any adverse events up to 30 days after treatment ends or until death. The primary outcome focuses on differences in tumor immune cells right after surgery, with follow-up evaluations up to 12 months. Participation may last until disease progression or study end, with ongoing monitoring throughout.

A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas