RecruitingPhase 2NCT07003542

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

Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas

Sponsor

Case Comprehensive Cancer Center

Enrollment

48 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Brain Tumor Glioblastoma

Summary

The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting specific immune cells called myeloid-derived suppressor cells (MDSCs) that suppress your body's natural immune response against cancer. Sitagliptin is an investigational drug for this condition that works by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-4), which MDSCs rely on to enter the brain and function. While sitagliptin is FDA-approved for diabetes treatment, its use in glioblastoma is investigational (experimental).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing sitagliptin — a diabetes drug — to see if it can affect brain tumors. Researchers believe it may slow the growth of grade 4 gliomas (the most aggressive type of brain tumor). Participants will take sitagliptin before a planned surgery, allowing doctors to examine how the drug affects the tumor. **You may be eligible if...** - You are over 18 years old - You have a confirmed WHO grade 4 glioma and are scheduled for brain surgery - You have never taken sitagliptin or similar diabetes medications (gliptins) - Your doctor believes you can tolerate a short course of a steroid (dexamethasone) before surgery - Your blood counts, liver, and kidney function meet required levels - You have a good functional status (Karnofsky score ≥ 60%) **You may NOT be eligible if...** - You have previously taken sitagliptin or another gliptin medication - Your organ function (blood, liver, kidneys) does not meet the study thresholds - You have active bleeding or are unable to safely manage blood thinners - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSitagliptin

Sitagliptin will be self-administered orally by participants. Dose level - sitagliptin * 1 100 mg daily * -1 50 mg daily * -2 25 mg daily

Locations(1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Cleveland, Ohio, United States

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NCT07003542

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