48 Participants Needed

Sitagliptin for Brain Cancer

DP
Overseen ByDavid Peereboom, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Case Comprehensive Cancer Center
Must be taking: Glucocorticoids
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the drug sitagliptin can help the immune system combat brain cancer, specifically glioblastoma. Typically used for diabetes, sitagliptin is being studied to determine if it can target specific immune cells that weaken the body's natural defense against the tumor. Participants will receive sitagliptin either before and after surgery or only after surgery. Individuals diagnosed with glioblastoma and scheduled for tumor removal surgery might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are on insulin or sulfonylurea for diabetes, or if you have uncontrolled diabetes. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that sitagliptin is likely to be safe for glioblastoma patients?

Research has shown that sitagliptin is generally well-tolerated. In a large study involving over 10,000 patients with type 2 diabetes, sitagliptin proved safe, with most participants not experiencing serious side effects.

Although the FDA has approved sitagliptin for diabetes, its use in treating brain cancer remains experimental. This means that while it is safe for diabetes patients, further research is necessary to confirm its safety for brain cancer patients.

Lab studies have demonstrated sitagliptin's potential in targeting brain cancer cells and aiding the immune system. This early evidence focuses on the drug's mechanism, not its safety in humans. So far, available studies have not reported major safety issues.

As this trial is in an early phase, sitagliptin has not shown serious safety concerns, allowing further research. However, new side effects might still emerge as more people use it for brain cancer.12345

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about sitagliptin for brain cancer because this drug offers a new approach by targeting the dipeptidyl peptidase-4 (DPP-4) enzyme, which is not typically addressed by current treatments like surgery, radiation, and chemotherapy. Sitagliptin, originally used for diabetes, could potentially disrupt cancer cell growth differently compared to conventional therapies. This novel mechanism of action may provide an additional tool in managing brain cancer, offering hope for improved outcomes.

What evidence suggests that sitagliptin might be an effective treatment for brain cancer?

This trial will evaluate sitagliptin for brain cancer treatment. Studies have shown that sitagliptin might help treat glioblastoma by enhancing the immune system's ability to fight the tumor. Research suggests that sitagliptin can block certain cells that aid the tumor's survival and growth. In animal studies, sitagliptin increased the survival time of mice with tumors. The drug works by inhibiting an enzyme necessary for some immune cells, potentially helping the body fight cancer more effectively. While sitagliptin is approved for treating diabetes, its use for brain cancer remains experimental and under study. Participants in this trial will receive either presurgical and post-surgical treatment with sitagliptin or post-surgical treatment alone.14567

Who Is on the Research Team?

DP

David Peereboom, MD

Principal Investigator

Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Institute

Are You a Good Fit for This Trial?

This trial is for patients with an aggressive brain cancer called grade 4 glioblastoma, who are looking for new treatment options. Specific eligibility criteria details were not provided.

Inclusion Criteria

Participants must have minimum intervals from prior treatments
I can swallow pills without any difficulty.
My doctor thinks I should have chemotherapy after surgery.
See 12 more

Exclusion Criteria

Participants with uncontrolled intercurrent illness
My diabetes is not under control.
Participants receiving any other investigational agents
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Presurgical Treatment

Participants receive sitagliptin before surgical resection to evaluate its impact on MDSCs

Duration not specified

Post-surgical Treatment

Participants receive sitagliptin and chemotherapy until disease progression

Until disease progression

Follow-up

Participants are monitored for adverse events and treatment effectiveness

Up to 30 days after treatment discontinuation

What Are the Treatments Tested in This Trial?

Interventions

  • Sitagliptin
Trial Overview The study tests if sitagliptin can boost the immune system's response to fight glioblastoma by blocking cells that weaken immunity. Sitagliptin is approved for diabetes but is experimental for this cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Group 2: Post surgical treatment with sitagliptinExperimental Treatment1 Intervention
Group II: Group 1: Presurgical and post surgical treatment with sitagliptinExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Citations

A Phase 2 and Pharmacodynamic Study of Sitagliptin in ...The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36966667/
Sitagliptin inhibits the survival, stemness and autophagy ...Sitagliptin administration prolonged the survival time of tumor-bearing mice. Sitagliptin could inhibit TMZ-induced protective autophagy and ...
Sitagliptin inhibits the survival, stemness and autophagy of ...These data supported that Sitagliptin could inhibit the growth and survival of glioma cells in vivo, and extended the survival of tumor-bearing mice. Fig. 4.
Sitagliptin for Brain CancerThe purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting ...
A Phase 2 and Pharmacodynamic Study of Sitagliptin in ...Overall survival at 12 months, 12 months post intervention. Overall survival rate after sitagliptin administration concurrent with chemotherapy for progressive ...
A Phase 2 and Pharmacodynamic Study of Sitagliptin in ...Study Purpose. The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by ...
Safety and tolerability of sitagliptin in clinical studies: a pooled ...In this updated pooled safety analysis of data from 10,246 patients with type 2 diabetes, sitagliptin 100 mg/day was generally well tolerated in clinical trials ...
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