Actively Recruiting
Targeting Macrophage Migration Inhibitory Factor: A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas
Led by Case Comprehensive Cancer Center · Updated on 2026-05-08
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether sitagliptin, an investigational drug, can improve the immune response against glioblastoma by targeting myeloid-derived suppressor cells (MDSCs), which suppress the body's natural defense against cancer. Glioblastoma patients have increased MDSCs, and reducing these cells may help reverse immunosuppression. This phase 2 study focuses on patients with progressive grade 4 gliomas who are undergoing surgery and chemotherapy. The investigation builds on prior findings that MDSCs rely on an enzyme called DPP-4, which sitagliptin inhibits. Participants will be divided into two groups: one will receive presurgical sitagliptin followed by post-surgical sitagliptin and chemotherapy, and the other will start sitagliptin only after surgery along with chemotherapy. Sitagliptin is taken orally at doses ranging from 25 mg to 100 mg daily, self-administered by participants. The study includes a "window of opportunity" period before surgery to assess the drug's biological impact, followed by ongoing treatment until disease progression. During the study, participants will undergo tumor resection surgery and receive laboratory tests to monitor organ function and blood counts. Researchers will measure immune cell changes in tumor tissue, focusing on CD8+ T cells, and track progression-free and overall survival at specified intervals. Safety will be assessed by recording adverse events up to 30 days after treatment ends. The total duration of participation varies depending on individual treatment response and disease progression.
CONDITIONS
Brief Title
A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed WHO grade 4 glioma with planned tumor resection
- No prior use of sitagliptin or other gliptin drugs
- Able to tolerate pre-operative dexamethasone 4 mg/day or equivalent
- Age over 18 years
- Karnofsky performance status of 60% or higher
- Adequate organ function including blood counts and liver/kidney tests within 21 days
- Stable full-dose anticoagulant use without active bleeding
- Negative pregnancy test if woman of childbearing potential
- Agreement to use contraception during and 30 days after treatment
- Ability to swallow whole tablets
- Minimum time intervals from prior treatments met (e.g., 4 weeks since surgery)
- HIV-positive patients with stable viral load and treatment
- Treated or undetectable hepatitis C virus infection
- Undetectable hepatitis B viral load or immunity
- Candidate for post-operative chemotherapy
- Willingness and ability to sign informed consent
You will not qualify if you...
- Unresolved prior treatment toxicities above Grade 1 (except alopecia and neuropathy)
- Use of other investigational agents
- Allergic reactions to sitagliptin or similar compounds
- Uncontrolled diabetes or use of insulin/sulfonylurea
- History of severe hypoglycemia or unsuitable for sitagliptin
- Uncontrolled illnesses including infections, heart failure, angina, arrhythmia, or psychiatric conditions
- Other malignancies that could interfere with study assessments
- Chronic gastrointestinal disorders causing significant diarrhea
- Pregnant or breastfeeding
- Unable or unwilling to swallow tablets
- Medical, laboratory, or psychiatric conditions making participation inappropriate in investigator's judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the day before surgery
Participants in the presurgical treatment group take sitagliptin daily before their surgery to evaluate its biological impact.
Daily oral medication until surgery
Duration - 1 day
Participants undergo clinically indicated surgical resection of their tumor.
1 visit (in-person, surgical procedure)
Duration - Until disease progression
Participants receive post-operative sitagliptin and chemotherapy until disease progression.
Regular follow-up visits as determined by clinical care
Duration - Up to 12 months post intervention
Participants are monitored for safety and survival outcomes after treatment ends.
Periodic visits up to 12 months
Trial Site Locations
Total: 1 location
1
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
D
David Peereboom, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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