Sitagliptin + Bevacizumab for Brain Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
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
Follow-up
Participants are monitored for safety and effectiveness after treatment, including event-free survival and overall survival
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
Phase I: Bevacizumab in combination with Sitagliptin Phase Ib: a standard 3+3 design and dose de-escalation will be used to determine the maximal tolerated dose (MTD) of sitagliptin in combination with bevacizumab on non-surgical patients with recurrent GBM Pilot: 12 patients with recurrent GBM, will receive pre-operative treatment with sitagliptin for at least 5 days at the MTD determined in phase 1b. These patients will then undergo surgical resection of the tumor. All patients will receive postoperative sitagliptin in addition to standard-of-care bevacizumab
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.
2.
consultqd.clevelandclinic.org
consultqd.clevelandclinic.org/novel-strategies-to-enhance-chemotherapy-in-advanced-glioblastomaNovel 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 ...
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 ...
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