Dasatinib + Quercetin + Fisetin + Temozolomide for Brain Tumor

(Senolytics Trial)

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Nursing, Swallowing issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 16 weeks (completion of 3 cycles)

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of medications to treat glioma, a type of brain tumor, in individuals who have residual tumor cells after previous treatment. The medications include dasatinib, which inhibits tumor cell growth, and temozolomide, which damages tumor cell DNA. Quercetin and fisetin, plant compounds, help remove old or damaged cells and may reduce inflammation. Participants may qualify if they have undergone prior treatment for glioma and still show tumor signs on medical scans. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that combining dasatinib and quercetin yielded promising results in earlier studies. After eight weeks of treatment with these compounds, older animals demonstrated improved learning and memory, suggesting good tolerance. Fisetin, a natural compound found in plants, is considered relatively safe at normal doses and is known for its potential to fight cancer and reduce inflammation.

Temozolomide, a medication already approved for treating certain types of brain cancer, can cause common side effects like nausea and tiredness. Its safety is well-established due to its widespread use in cancer treatment.

This trial is in an early stage, so researchers are still collecting information on the safety of these combinations for humans. While past research provides some confidence, a complete understanding of safety will develop as more data is gathered. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for brain tumors because they combine natural compounds like quercetin and fisetin with established drugs like dasatinib and temozolomide. This unique combination targets tumor cells in multiple ways, potentially enhancing the effectiveness of the treatment. Dasatinib and quercetin work together to inhibit specific pathways that promote tumor growth, while fisetin and temozolomide may enhance apoptosis, or programmed cell death, in cancer cells. By using these varied mechanisms, the treatments aim to provide a more comprehensive attack on the tumor, which could lead to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for glioma?

Research has shown that dasatinib, one of the treatments in this trial, can block signals that help tumor cells grow, potentially stopping brain tumors from spreading. Quercetin, another treatment option, has been found to kill certain cancer cells by interfering with their survival. Fisetin, also under study, may reduce tumor growth by cutting off the tumor's blood supply. Temozolomide, included in some trial regimens, is a chemotherapy drug that damages the DNA of tumor cells, slowing or stopping their growth. The trial's various treatment arms will explore these treatments individually and in combination, potentially improving outcomes for patients with remaining glioma. ^{1 2 3 6 7}

Who Is on the Research Team?

Terence C. Burns, MD, PhD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a prior glioma diagnosis treated with chemo or radiation, showing stable disease but still having residual tumor cells. Participants must have either IDH-mutant or MGMT-methylated glioma, an ECOG score of 0-2 and be fairly active (Karnofsky ≥50). They need normal blood counts and liver function within certain limits, as well as adequate kidney function.

Inclusion Criteria

I was treated for a brain tumor and my condition hasn't worsened.

I can take care of myself but may not be able to do heavy physical work.

Hemoglobin ≥ 9.0 g/dL (≤ 15 days prior to registration)

Exclusion Criteria

Nursing persons

I am not willing to use birth control during the study.

Pregnant persons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sequential treatments or combinations including dasatinib, quercetin, fisetin, and/or temozolomide. Each cycle lasts 35 days, and patients are monitored for disease progression or unacceptable toxicity.

Up to 16 weeks (completion of 3 cycles)

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of adverse events and changes in disease volume.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Dasatinib
• Fisetin
• Quercetin
• Temozolomide

Trial Overview The trial tests combinations of dasatinib, quercetin, fisetin, and temozolomide on patients with previously treated gliomas that still have remaining tumor cells. Dasatinib blocks proteins that signal tumors to grow; quercetin and fisetin are plant compounds targeting aging cells causing inflammation; temozolomide damages DNA in tumor cells.

How Is the Trial Designed?

Group I: Regimen 6 (fisetin, temozolomide) Experimental Treatment 6 Interventions

Patients receive temozolomide PO QD on days 1-5 and fisetin PO QD on days 14-15 of each cycle. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients without a PR or CR on imaging at the end of cycle 1 proceed to end of study treatment and study follow up. Patients with a PR or CR may remain on the current regimen. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Group II: Regimen 5 (dasatinib, quercetin, temozolomide) Experimental Treatment 7 Interventions

Patients receive temozolomide PO QD on days 1-5, quercetin PO QD days 14-15 and dasatinib PO QD on days 14-15 of each cycle. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients without a PR or CR on imaging at the end of cycle 1 proceed to regimen 6. Patients with a PR or CR may remain on the current regimen. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Group III: Regimen 4 (temozolomide) Experimental Treatment 5 Interventions

Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients without a PR or CR on imaging at the end of cycle 1 proceed to regimen 5. Patients with a PR or CR may remain on the current regimen. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Group IV: Regimen 3 (fisetin) Experimental Treatment 5 Interventions

Patients receive fisetin PO QD on days 1-2 of each cycle. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients without a PR or CR on imaging at the end of cycle 1 proceed to regimen 4. Patients with a PR or CR may remain on the current regimen. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Group V: Regimen 2 (dasatinib, quercetin) Experimental Treatment 6 Interventions

Patients receive dasatinib PO QD on days 1-2 and quercetin PO QD on days 1-2 of each cycle. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity. Patients without a PR or CR on imaging at the end of cycle 1 proceed to regimen 3. Patients with a PR or CR may remain on the current regimen. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Group VI: Regimen 1 (rest, no treatment) Active Control 5 Interventions

Patients receive rest and take no treatment on days 1-35 of cycle 1. Patients at the end of cycle 1 proceed to regimen 2. Additionally, patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study. Patients may undergo 18F-DOPA-PET scans on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. trials.braintumor.org trials.braintumor.org/trials/NCT07025226

Sequential Treatments or Combinations Including Dasatinib ... This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8833137/

Combination of dasatinib and quercetin improves cognitive ... Here we report that 8 weeks treatment with D+Q alleviated learning deficits and memory impairment observed in aged animals.

3. cancer.gov cancer.gov/clinicaltrials/NCI-2025-03841

Medication Combinations of Dasatinib, Quercetin, Fisetin ... This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in ...

4. withpower.com withpower.com/trial/early-phase-1-glioma-7-2025-0a461

Dasatinib + Quercetin + Fisetin + Temozolomide for Brain ... This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0944711323002945

Quercetin induces MGMT+ glioblastoma cells apoptosis via ... Quercetin, a phytoingredient capable of crossing the blood-brain barrier, has shown effectiveness in the treatment of various solid tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07025226

Study Details | NCT07025226 | Sequential Treatments or ... Giving medication combinations of dasatinib, quercetin, fisetin and temozolomide may be safe, tolerable and/or effective in treating patients with previously ...

7. aging-us.com aging-us.com/article/205581/text

Exploring the effects of Dasatinib, Quercetin, and Fisetin on ... This pilot study aims to establish the safety, efficacy, and feasibility of Quercetin and Dasatinib as a potential treatment to enhance the clinical care of ...