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New treatment option for Glioblastoma
Official title A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas
ClinicalTrials.gov ID: NCT07003542
What this study is testing
What is Sitagliptin?
Sitagliptin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma)...
- Participants must not have received sitagliptin or other gliptins.
- Participants must, in the opinion of the investigator be able to tolerate a pre-operative dexamethasone dose of 4 mg/d or the equivalent dose of an...
- Age \>18 years
- Karnofsky performance status ≥ 60%
You likely can't join if
- Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.
- Participants receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin.
- Participants with uncontrolled diabetes mellitus
- Participants who require insulin therapy or a sulfonylurea
- Participants with documented history of hypoglycemia requiring medical intervention or who in the opinion of the investigator are not suitable to...
See the full eligibility criteria
Who can join
- Participants must have histologically or cytologically confirmed WHO grade 4 glioma (including tumors with molecularly defined grade 4 astrocytoma) for whom a clinically-indicated tumor resection is planned.
- Participants must not have received sitagliptin or other gliptins.
- Participants must, in the opinion of the investigator be able to tolerate a pre-operative dexamethasone dose of 4 mg/d or the equivalent dose of an alternate glucocorticoid.
- Age \>18 years
- Karnofsky performance status ≥ 60%
- Participants must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
- 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.
- 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.
- 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...
- Participants must be able to swallow whole tablets.
- 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
- 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
- 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...
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Note: A known positive test for HBV surface antigen (HBV sAg)...
- Patient must be deemed by investigator to be a candidate for post-operative chemotherapy.
- Participants must have the ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia and neuropathy.
- Participants receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sitagliptin.
- Participants with uncontrolled diabetes mellitus
- Participants who require insulin therapy or a sulfonylurea
- Participants with documented history of hypoglycemia requiring medical intervention or who in the opinion of the investigator are not suitable to receive sitagliptin.
- Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric...
- Other prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen are excluded. Otherwise, participants...
- Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology at screening) (National Cancer Institute [NCI] Common...
- Pregnant or breastfeeding.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.