45 Participants NeededMy employer runs this trial

Sitagliptin + Bevacizumab for Brain Cancer

KY
Overseen ByKailin Yang, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of drugs, sitagliptin (a diabetes medication) and bevacizumab (an anti-cancer drug), to determine their effectiveness in treating gliomas (a type of brain cancer) that have recurred or worsened after treatment. Researchers aim to identify the optimal dose of sitagliptin to use with bevacizumab. Individuals with a recurrent brain tumor, not currently on these drugs, and diagnosed with grade 4 glioma may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this novel combination therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients on full-dose anticoagulants can participate if they meet certain criteria, and those on investigational agents cannot participate. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bevacizumab, one of the drugs in this study, is usually well-tolerated by patients with recurring glioblastoma. Studies have found it can delay cancer progression and improve quality of life.

The FDA has already approved sitagliptin for treating diabetes, indicating its safety for humans. However, combining sitagliptin with bevacizumab for brain cancer is a new approach. This trial aims to determine the safest dose when using these two drugs together. As an early-phase trial, the treatment is still being tested for safety in this new context. Researchers will closely monitor participants to assess how well they tolerate the combination.12345

Why do researchers think this study treatment might be promising?

Unlike the standard of care for recurrent glioblastoma multiforme (GBM), which often includes treatments like temozolomide and bevacizumab alone, the combination of sitagliptin and bevacizumab introduces a unique approach. Sitagliptin, typically known for managing diabetes by inhibiting the enzyme DPP-4, may have a role in enhancing the effectiveness of bevacizumab by potentially impacting tumor growth pathways. Researchers are excited about this combination as it explores a novel mechanism of action that targets both blood vessel growth and metabolic pathways in cancer cells, which could lead to better outcomes for patients. This innovative approach has the potential to improve treatment efficacy and offer hope for a condition with limited options.

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

Research has shown that bevacizumab may help treat recurrent glioblastoma, a type of brain cancer, by extending the time patients live without the cancer worsening. Some studies found that this treatment improved the time patients lived without disease progression to between 42.6% and 50.3% at six months. Bevacizumab also reduces harmful immune cells, aiding the body's fight against tumors. In this trial, participants will receive a combination of bevacizumab and sitagliptin. Researchers are testing sitagliptin because it might enhance the immune response against these tumors. Although sitagliptin is still under investigation for this purpose, it targets specific pathways that could help fight gliomas when used with bevacizumab.34567

Who Is on the Research Team?

KY

Kailin Yang, MD, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults over 18 with grade 4 glioma (a type of aggressive brain tumor) that has come back or gotten worse after treatment. Participants must be able to swallow tablets, have good organ function, controlled blood pressure, and not be pregnant or breastfeeding.

Inclusion Criteria

I am a woman of childbearing age and have tested negative for pregnancy before treatment.
I am able to swallow whole tablets.
Phase 1b: Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study registration
See 19 more

Exclusion Criteria

I have a history of type 1 diabetes, uncontrolled type 2 diabetes, or severe low blood sugar.
I cannot or do not want to swallow tablets.
Pregnant or breastfeeding
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase Ib Treatment

Participants receive sitagliptin in combination with bevacizumab to determine the maximal tolerated dose using a 3+3 design and dose de-escalation

56 days
Multiple visits for dose escalation and monitoring

Pilot Phase Treatment

12 patients receive pre-operative treatment with sitagliptin for at least 5 days at the MTD, followed by surgical resection and postoperative sitagliptin with bevacizumab

5 days pre-op + 28 days post-op cycle
Pre-operative and post-operative visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including event-free survival and overall survival

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • Sitagliptin

Trial Overview

The study tests sitagliptin combined with bevacizumab to see if this combo helps treat recurring or progressing grade 4 gliomas and to find the safest highest dose of sitagliptin when used together. Both drugs are given by standard methods.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Standard of care Bevacizumab in addition to SitagliptinExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kailin Yang, MD, PhD

Lead Sponsor

Citations

Efficacy and safety of bevacizumab for the treatment of ... - PMC

Previous studies have demonstrated that BEV may be an effective treatment for recurrent GBM, with prolonged progression-free survival and overall survival.

Novel Strategies to Enhance Chemotherapy in Advanced GBM

Progression-free survival at six months was 15%, better than expected from standard treatment, and overall survival at 12 months was 21%, about ...

NCT07003542 | A Phase 2 and Pharmacodynamic Study ...

The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting ...

Sitagliptin in Recurrent/Progressive Grade 4 Glioma

Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or ...

Use of bevacizumab in recurrent glioblastoma - PMC

Phase II clinical trials utilizing bevacizumab-containing regimens improved 6-month progression-free survival to 42.6–50.3% in comparison to historical Phase II ...

Sitagliptin in Recurrent/Progressive Grade 4 Glioma

Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23585688/

Safety and efficacy of bevacizumab for glioblastoma ...

Bevacizumab monotherapy has proven effective for recurrent glioblastoma, and it extended progression-free survival and improved patient quality of life in ...