Phase 2 Study of Sitagliptin for Grade 4 Gliomas
This study is testing whether sitagliptin, a drug approved for diabetes, can help your body's immune system fight glioblastoma (a type of brain tumor). Researchers believe sitagliptin might work by reducing certain immune cells (myeloid-derived suppressor cells or MDSCs) that can stop your immune system from attacking the tumor. You could be eligible if you have a confirmed Grade 4 glioma and are planning to have surgery. The main goal is to see if sitagliptin increases the number of specific immune cells (CD8+ T cells) in your tumor after surgery. This study plans to enroll 48 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 48 participants. It is testing different daily doses of sitagliptin (25 mg, 50 mg, or 100 mg).
- What's involved
- Sitagliptin will be taken by mouth daily. The primary measurement is taken up to one day after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured up to day 1 postsurgical.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07003542
A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas
Recruiting
PHASE2Ages 18+InterventionalTreatmentCase Comprehensive Cancer CenterInvestigator-initiated
~48 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Sitagliptin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in tumor CD8+ T cell count between the participants randomized to pre-surgical sitagliptin versus the participants randomized to no pre-surgical treatment.
Measured over Up to day 1 postsurgical
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- David Peereboom, MD · PRINCIPAL_INVESTIGATOR · Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Hemoglobin ≥ 9 g/dl
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Total bilirubin \< 1.5x institutional upper limit of normal (ULN)
AST (SGOT) ≤ 3x institutional ULN
ALT (SGPT) ≤ 3x institutional ULN
Calculated creatinine clearance \> 50 mL/min or creatinine \< 1.5x institutional upper limit of normal (ULN)
Prothrombin time/international normalized ratio (PT/INR) \< 1.4 for participants not on warfarin. 7. Participants on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
In-range INR (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin. 8. Women of childbearing potential must have a negative pregnancy test within 21 days of study entry. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while taking part in this study, she should inform her treating physician immediately. Men of reproductive potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug. 9. Participants must be able to swallow whole tablets. 10. Participants must have the following minimum intervals from prior treatments:
surgery - 4 weeks
nitrosoureas - 6 weeks
cytotoxic chemotherapy - standard intervals depending on the most recent regimen. E.g., for temozolomide 23 days after most recent dose.
For drugs not listed, the research nurse, treating investigator, and principal investigator will decide on the appropriate interval.
Investigational therapy or non-cytotoxic therapy - 2 weeks.
For bevacizumab - 4 weeks from expected date of protocol surgery 11. Participants positive for human immunodeficiency virus (HIV) are allowed on study (note: HIV testing is not required), but HIV-positive participants must have:
An undetectable viral load within 6 months of registration.
A stable regimen of highly active anti-retroviral therapy (HAART)
No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections 12. For participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load Note: Known positive test for HCV ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. 13. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
What this trial measures
- Difference in tumor CD8+ T cell count between the participants randomized to pre-surgical sitagliptin versus the participants randomized to no pre-surgical treatment.Up to day 1 postsurgical