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

Launched by MAYO CLINIC · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring new treatment options for people with glioma, a type of brain tumor, who have already received treatment but still have some tumor cells remaining. The study is testing combinations of four medications: dasatinib, quercetin, fisetin, and temozolomide. Dasatinib works by blocking signals that help tumor cells grow, while quercetin and fisetin are natural plant compounds that may help remove old or damaged cells that can cause inflammation. Temozolomide is a chemotherapy drug that works by damaging the tumor cells’ DNA to stop their growth. The goal of the trial is to see if these combinations are safe and effective for patients with glioma that has specific genetic features and has not fully responded to prior treatments.

People who might be eligible for this study are adults (18 years or older) who have been diagnosed with glioma and have already undergone chemotherapy and/or radiation, with stable disease but some remaining tumor visible on scans. Participants need to have certain genetic markers in their tumor (IDH-mutant or MGMT-methylated glioma) and be in generally good health based on specific lab tests and physical ability. Those who are pregnant, nursing, or unable to take pills by mouth would not be eligible. If accepted into the trial, participants will receive the study medications and will be asked to provide blood and spinal fluid samples for research. They will also need to return to the Mayo Clinic for follow-up visits. This study is currently not yet recruiting but aims to find safer and more effective treatments for people living with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stable disease 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 are eligible
• • Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2, and Karnofsky performance status \>= 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 lab assessment) (≤ 15 days prior to registration)
• • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x upper limit of normal (ULN) (or ≤ 5 x ULN for patients with liver involvement) (≤ 15 days prior to registration)
• • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula (≤ 15 days 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 1920)
• • Negative serum pregnancy test is required for persons of childbearing potential ≤ 8 days prior to registration
• • Presence of an implanted cranial CSF access device, such as Ommaya reservoir or ventriculoperitoneal 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 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 are unwilling to employ adequate contraception
• • Patients who are not appropriate medical candidates due to current or past medical history or uncontrolled concurrent illness which limits safety of or compliance to study proceedings
• • Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication
• • NOTE: This includes but not limited to, refractory vomiting, gastric resection/bypass, or duodenal/jejunal resection
• • Patients with known hypersensitivity or allergy to all of the study drugs on the protocol (known hypersensitivity or allergy to one drug does not preclude participation in this protocol)
• • Inability to undergo MRI scans