Sequential Treatments or Combinations Including Dasatinib, Quercetin, Fisetin and/or Temozolomide for the Treatment of Previously Treated Glioma With Residual Disease

Last updated: July 15, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Not Recruiting

Phase

1

Condition

Brain Cancer

Astrocytoma

Brain Tumor

Treatment

Positron Emission Tomography

Dasatinib

Temozolomide

Clinical Study ID

NCT07025226
MC230715
MC230715
23-008241
NCI-2025-03841
  • Ages > 18
  • All Genders

Study Summary

This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide work in treating patients with glioma for which the patient has received treatment in the past (previously treated) and for tumor cells that remain after attempts to treat the tumor have been made (residual disease). Dasatinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply, which may help keep tumor cells from growing. Quercetin and fisetin are compounds found in plants. They have antioxidant and anti-inflammatory properties and help remove senescent cells, older or damaged cells that have stopped dividing but don't die off as they should and build up in tissues over time. Senescent cells may cause inflammation or damage to nearby healthy cells. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. Giving medication combinations of dasatinib, quercetin, fisetin and temozolomide may be safe, tolerable and/or effective in treating patients with previously treated glioma with residual disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stabledisease based on Response Assessment in Neuro-Oncology (RANO) criteria

  • Must have IDH-mutant OR MGMT-methylated glioma

  • NOTE: Patients with any radiographic evidence of residual disease areeligible

  • Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2, and Karnofsky performancestatus >= 50

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

  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (≤ 15 days prior to registration)

  • Platelet count ≥ 100,000/mm^3 (without transfusion ≤ 7 days preceding labassessment) (≤ 15 days prior to registration)

  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limitof normal (ULN) (or ≤ 5 x ULN for patients with liver involvement) (≤ 15 days priorto registration)

  • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (≤ 15days prior to registration)

  • Average corrected QT interval (QTc) ≤ 450 ms on triplicate 12 lead electrocardiogram (ECG) ≤ 29 days prior to registration

  • NOTE: QTc intervals will be corrected using Fridericia's formula (Fridericia

  • Negative serum pregnancy test is required for persons of childbearing potential ≤ 8days prior to registration

  • Presence of an implanted cranial CSF access device, such as Ommaya reservoir orventriculoperitoneal shunt

  • Willingness to provide blood and CSF samples for research

  • Co-enrollment on the neuro-oncology biorepository [institutional review board (IRB) 12-003458] for collection of research blood and CSF samples

  • Provide written informed consent

  • Willingness to return to Mayo Clinic for follow-up

Exclusion

Exclusion Criteria:

  • Any of the following because this study involves an agent that has known genotoxic,mutagenic and teratogenic effects:

  • Pregnant persons

  • Nursing persons

  • Persons of childbearing potential and persons able to father a child who areunwilling to employ adequate contraception

  • Patients who are not appropriate medical candidates due to current or past medicalhistory or uncontrolled concurrent illness which limits safety of or compliance tostudy proceedings

  • Participants who are unable to swallow tablets or who are at risk for impairedabsorption of oral medication

  • NOTE: This includes but not limited to, refractory vomiting, gastricresection/bypass, or duodenal/jejunal resection

  • Patients with known hypersensitivity or allergy to all of the study drugs on theprotocol (known hypersensitivity or allergy to one drug does not precludeparticipation in this protocol)

  • Inability to undergo MRI scans

Study Design

Total Participants: 10
Treatment Group(s): 9
Primary Treatment: Positron Emission Tomography
Phase: 1
Study Start date:
November 01, 2025
Estimated Completion Date:
September 01, 2027

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.