New pilot study aims to personalize glioma treatment with drug cocktails
NCT ID NCT07025226
First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-phase trial at Mayo Clinic is testing combinations of four drugs (dasatinib, quercetin, fisetin, and temozolomide) in 30 adults with previously treated glioma that still has residual tumor cells. The goal is to see if it's feasible to use individual patient data from blood, spinal fluid, and scans to guide which drug combination to use next. The study focuses on safety and turnaround time for test results, not yet on curing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dasatinib, quercetin, fisetin, and temozolomide
- What this could lead to
- If successful, this could point toward a way to personalize treatment for glioma patients with leftover tumor cells after standard therapy.
- What could go wrong
- This is a very early (Phase 1) pilot study with only 30 participants. It primarily tests feasibility and safety, not effectiveness. The drug combinations may cause side effects or not work as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria - Treatment Arm (Regimens 1-8): * 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 Inclusion Criteria - Monitoring Arm (Regimen 1 only): * 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 Criteria - Treatment Arm (Regimens 1-8): * 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 Exclusion Criteria - Monitoring Arm (Regimen 1 only): * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Rochester
RECRUITINGRochester, Minnesota, 55905, United States
Contact Email: •••••@•••••
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