Actively Recruiting
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
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 treatment with sitagliptin or other gliptins
- Able to tolerate pre-operative dexamethasone dose of 4 mg/day or equivalent
- Age over 18 years
- Karnofsky performance status of 60% or higher
- Adequate organ function and lab values within 21 days before study entry
- Stable use of full-dose anticoagulants if applicable, with no active bleeding
- Negative pregnancy test for women of childbearing potential within 21 days before study entry
- Agreement to use adequate contraception during and 30 days after study participation
- Ability to swallow whole tablets
- Minimum intervals from prior treatments met (e.g., surgery 4 weeks, nitrosoureas 6 weeks)
- HIV-positive participants with undetectable viral load and stable therapy allowed
- Participants with treated or controlled hepatitis B or C infections
- Candidate for post-operative chemotherapy as determined by investigator
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Unresolved prior treatment toxicities above Grade 1 except alopecia and neuropathy
- Receiving any other investigational agents
- History of allergic reactions to sitagliptin or similar compounds
- Uncontrolled diabetes mellitus
- Current insulin or sulfonylurea therapy
- History of hypoglycemia requiring medical intervention or unsuitable for sitagliptin
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues affecting compliance
- Other malignancies that may interfere with safety or efficacy assessments
- Significant chronic gastrointestinal disorder with diarrhea symptoms
- Pregnant or breastfeeding
- Unable or unwilling to swallow tablets
- Significant medical, laboratory, or psychiatric issues making participation inappropriate
AI-Screening
AI-Powered Screening
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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
CONTACT
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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