Medication Combinations for Previously Treated Glioma

This early-phase study is looking at the safety and effects of combining several medications for people with glioma (a type of brain tumor) that has been treated before and still has some tumor cells remaining. The medications being tested are dasatinib, quercetin, fisetin, temozolomide, LMP744, and an autologous TLPO vaccine. Dasatinib works by blocking a protein that helps tumor cells grow. Quercetin and fisetin come from plants. You may be able to join if you are 18 or older, have previously treated glioma that is either IDH-mutant or MGMT-methylated, and still have some tumor remaining. The study aims to see how many people complete 3 cycles of treatment and how quickly scan and marker data are available within 16 weeks. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is an early-phase trial, but the specific phase is not stated.
What's involved
Participants will have blood samples collected and undergo MRI scans. Some participants will receive rest and no treatment. The primary endpoints are measured up to 16 weeks, which suggests the treatment period.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at up to 16 weeks (completion of 3 cycles), which indicates the duration of observation for these specific outcomes.

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NCT07025226

Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Mayo Clinic
~30 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDasatinibFisetinMagnetic Resonance ImagingPatient ObservationPositron Emission Tomography

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion of 3 cycles
Measured over Up to 16 weeks
+1 more outcome measured
Glioma
1 sites across 1 states
Minnesota1
  • Terence C. Burns, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

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Eligibility criteria

Inclusion

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
Age ≥ 18 years
Prior diagnosis of a glioma
Negative serum pregnancy test is required for persons of childbearing potential ≤ 8 days prior to registration
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

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
NOTE: An exception can be granted for such patients if no oral medications are planned (i.e., patient will receive only IV or intradermal agents)
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
NOTE: These patients may be enrolled in the Monitoring Arm
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
Current or past medical history or uncontrolled concurrent illness which limits safety or compliance with study proceedings
Known hypersensitivity or allergy to radioactive tracers
Inability to undergo clinical imaging
  • Completion of 3 cyclesUp to 16 weeks

    Will evaluate feasibility of serially screening multiple candidate therapies or combinations based on individualized empiric biological feedback from biospecimens and imaging. This will be measured as the percentage of patients successfully completing 3 cycles of drug administration (study visits). A cycle is 35 +/- 7 days. Regimen will be considered feasible if at least 2/3 of patients can achieve this target.

  • Turnaround time for scan and marker dataUp to 16 weeks (completion of 3 cycles)

    Will also evaluate feasibility as the turnaround time for scan and marker data that is used to determine if patients should stay on current therapy or move to the next regimen. The outcomes will be cycle-specific. A cycle is 35 +/- 7 days. The target for this is a mean turnaround time of 3 days; if the maximum turnaround time exceeds 5 days, this will prompt an evaluation of process to identify barriers.