Sitagliptin and Bevacizumab for Recurrent Grade 4 Glioma
This study is testing a combination of two drugs, sitagliptin and bevacizumab, for people with Grade 4 glioma (a type of brain tumor) that has come back or gotten worse after initial treatment. Researchers want to find the safest and most effective dose of sitagliptin when given with bevacizumab, which is a standard treatment. They also want to see if sitagliptin can help by reducing certain immune cells called Myeloid Derived Suppressor Cells (MDSCs) that can make tumors grow. The study is enrolling 45 participants and is currently unclear about its recruitment status. To join, you must be at least 18 years old and have a confirmed Grade 4 glioma that has recurred or progressed.
- Study design
- This is an interventional study with a planned enrollment of 45 participants. It involves a Phase Ib to determine the best dose, followed by a pilot phase.
- What's involved
- You would receive sitagliptin by mouth and bevacizumab intravenously (through a vein) until your disease progresses. For some participants, this would involve pre-operative treatment for at least 5 days, followed by surgery and post-operative treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures side effects from the first day of treatment through the completion of cycle 2 (each cycle is 28 days). Changes in certain cell concentrations are measured from before treatment to the end of post-operative cycle 1.
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NCT07541781
Sitagliptin in Recurrent/Progressive Grade 4 Glioma
Recruiting
PHASE1Ages 18+InterventionalTreatmentKailin Yang, MD, PhDInvestigator-initiated
~45 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:SitagliptinBevacizumab
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ib: Dose-limiting toxicities as measured by CTCAE v5.0
Measured over First day of treatment through completion of cycle 2 of therapy (each cycle is 28 days)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesIowa1
Study leadership
- Kailin Yang, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Iowa
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
Subjects must not have received sitagliptin or bevacizumab for this disease.
Age \>18 years
Performance status: ECOG performance status 0-2
Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
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
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days prior to treatment start. 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 participating in this study, she should inform her treating physician immediately. Men 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.
Subjects must be able to swallow whole tablets.
Participants must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study treatment
Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1 Day 1:
surgery - 4 weeks
nitrosoureas - 6 weeks
cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.
For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
Investigational therapy or non-cytotoxic GBM related therapy - 2 weeks
Subject is not deemed as a surgical candidate.
Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
Subjects must not have received sitagliptin or bevacizumab for this disease.
Age \>18 years
Performance status: ECOG performance status 0-2
Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
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
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential, defined as any female who has experienced menarche and has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy) and is not postmenopausal (≥12 months of spontaneous amenorrhea without an alternative medical cause), must have a negative pregnancy test within 7 days of treatment start. 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 participating in this study, she should inform her treating physician immediately. Men 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.
Subjects must be able to swallow whole tablets.
Subjects must have controlled blood pressure, defined as systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 100 mg Hg, with or without antihypertensive therapy
Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior to treatment start
Subjects must have the following minimum intervals from prior treatments until planned treatment initiation of Cycle 1Day1:
surgery - 4 weeks
nitrosoureas - 6 weeks
cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose.
For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval.
Investigational therapy or GBM related non-cytotoxic therapy - 2 weeks
For bevacizumab (if for a different cancer) - 4 weeks from the expected date of protocol surgery
Subject is deemed as a surgical candidate.
Exclusion
Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except for alopecia and neuropathy.
Subjects receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin or bevacizumab.
Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Known HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sitagliptin and/or bevacizumab. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy.
Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of Gleason Score 6 or less with stable prostate specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas.
Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events Version 5.0 \[CTCAE v.5.0\] diarrhea of any etiology at screening).
Known active infection with hepatitis B or hepatitis C virus.
Pregnant or breastfeeding.
Subjects who receive insulin or sulfonylurea for diabetes mellitus.
Subjects with history of type 1 diabetes, uncontrolled type 2 diabetes, hypoglycemia requiring medical intervention, or those who are deemed not suitable to receive sitagliptin at the discretion of the investigators.
Unable or unwilling to swallow tablets.
Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator's judgment, make the patient inappropriate for this study.
Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study consent.
Subjects with history of hematologic bleeding disorder.
What this trial measures
- Phase Ib: Dose-limiting toxicities as measured by CTCAE v5.0First day of treatment through completion of cycle 2 of therapy (each cycle is 28 days)
A dose limiting toxicity (DLT) is defined as any of the following sitagliptin-related adverse event (AE) that occurs during the DLT period (first day of treatment through completion of cycle 2 of therapy; each cycle is 28 days), graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
- Pilot: Change in participants' concentration of circulating MDSCs with treatmentFrom pre- to post-treatment (end of post-op cycle 1; each cycle is 28 days).
A two-sided p-value for a test of the null hypothesis, that the ΔPost-Pre in MDSCs is equal to 0 versus the alternative, that it is not equal to 0, will be computed using a one-sample test. In addition, the mean and two-sided 95% confidence interval will be reported.