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New pilot study aims to personalize glioma treatment with drug cocktails

NCT ID NCT07025226

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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