Medication Combinations of Dasatinib, Quercetin, Fisetin, Temozolomide, LMP744, and Autologous TLPO Vaccine for the Treatment of Previously Treated Glioma With Residual Disease (Senolytics)
June 30, 2026 updated by: Mayo Clinic
MC230715 Pilot Study of the Mechanistic Feedback From CNS Tumors With Latent Residual Disease to Guide Individualized Therapies
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous tumor lysate particle only (TLPO) vaccine 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.
LMP744 works by interfering with a protein that tumor cells use to copy and repair their DNA.
By blocking this repair process, the drug causes DNA damage so that tumor cells cannot survive.
The autologous TLPO vaccine is made using material from a patient's own tumor.
It delivers the tumor material to immune cells so they can learn to recognize and attack the cancer.
Giving medication combinations of dasatinib, quercetin, fisetin, temozolomide, LMP744, and autologous TLPO vaccine may be safe, tolerable and/or effective in treating patients with previously treated glioma with residual disease.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Terry Burns, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Regimen 1 (1 cycle rest, assignment to treatment regimen)
Patients receive rest and take no treatment on days 1-35 of cycle 1.
At the end of cycle 1, patients may proceed to regimens 2, 3, 4, 5, 6, 7, or 8. Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Receive rest and take no treatment
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 2 (dasatinib, quercetin)
Patients receive dasatinib PO QD on days 1-2 and quercetin PO QD on days 1-2 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Given PO
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 3 (fisetin)
Patients receive fisetin PO QD on days 1-2 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 4 (temozolomide)
Patients receive temozolomide PO QD on days 1-5 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 5 (dasatinib, quercetin, temozolomide)
Patients receive temozolomide PO QD on days 1-5, quercetin PO QD days 14-15 and dasatinib PO QD on days 14-15 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Given PO
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 6 (fisetin, temozolomide)
Patients receive temozolomide PO QD on days 1-5 and fisetin PO QD on days 14-15 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Monitoring Arm
Patients take no treatment and undergo monitoring only.
Patients receive rest as in Regimen 1 and do not proceed to any treatment on study.
Patients undergo MRI throughout the study as well as undergo blood and CSF sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Receive rest and take no treatment
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
|
|
Experimental: Regimen 7 (LMP744)
Patients receive LMP744 IV over 1 hour on days 1-5 of each cycle.
Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
Given IV
Other Names:
|
|
Experimental: Regimen 8 (autologous TLPO vaccine)
Patients receive autologous TLPO vaccine ID on day 1 of cycles 1-3 and cycles 6, 9, and 12. Cycles repeat every 35 days in the absence of disease progression or unacceptable toxicity.
Patients without a PR or CR on imaging at the end of cycle 1 may proceed to another regimen.
NOTE: Patients may continue receiving autologous TLPO vaccine after proceeding to another regimen.
Patients with a PR or CR may remain on the current regimen.
Additionally, patients undergo MRI throughout the study as well as undergo blood sample collection on study.
Patients may undergo amino acid PET scans on study.
|
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Undergo amino acid PET scan (optional)
Other Names:
Given autologous TLPO vaccine ID
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of 3 cycles
Time Frame: Up 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.
|
Up to 16 weeks
|
|
Turnaround time for scan and marker data
Time Frame: Up 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.
|
Up to 16 weeks (completion of 3 cycles)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of adverse events
Time Frame: Up to 3 years
|
Will assess the safety of this algorithm-based approach to individualized therapeutic drug combinations in patients with pre-recurrent central nervous system tumors.
The study drugs will be considered well-tolerated with no grade 3 or higher adverse event attributable to the drugs in the 10 patients.
Adverse events will be evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria and summarized by type and severity as well as perceived attribution to study treatment for each of the regimens received by patients.
|
Up to 3 years
|
|
Change in senescence-associated proteins
Time Frame: Baseline; up to 3 years
|
Will evaluate relative change from baseline in enrichment for a panel of senescence-associated proteins in cerebrospinal fluid (CSF) for each sequentially administered senolytic agent.
An effective senolytics regimen will decrease CSF senescence associated secretory phenotype, including monocyte chemoattractant protein-1 levels, by at least 25%.
|
Baseline; up to 3 years
|
|
Cell-free mitochondrial deoxyribonucleic acid (DNA)
Time Frame: Baseline; up to 3 years
|
Will evaluate the percentage change in cell-free mitochondrial DNA.
An effective senolytics regimen will decrease cell-free mitochondrial DNA by at least 25%.
|
Baseline; up to 3 years
|
|
2-Hydroxyglutarate (2-HG)
Time Frame: Baseline; up to 3 years
|
Will evaluate the percentage change in 2-HG.
|
Baseline; up to 3 years
|
|
Amplified DNA junctions
Time Frame: Baseline; up to 3 years
|
Will evaluate the percentage change in amplified DNA junctions (if applicable).
|
Baseline; up to 3 years
|
|
Volume of disease
Time Frame: Baseline; up to 3 years
|
Will evaluate the percentage change in the volume of disease above a tumor to normal standardized uptake value maximum ratio of 2 from fluorodopa F 18-positron emission tomography.
|
Baseline; up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terence C. Burns, MD, PhD, Mayo Clinic in Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
June 9, 2025
First Submitted That Met QC Criteria
June 9, 2025
First Posted (Actual)
June 17, 2025
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
June 30, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Health Services Administration
- Sulfur Compounds
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Heterocyclic Compounds, 2-Ring
- Heterocyclic Compounds, Fused-Ring
- Investigative Techniques
- Methods
- Therapeutics
- Pyrans
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Thiazoles
- Azoles
- Quality of Health Care
- Dacarbazine
- Triazenes
- Imidazoles
- Pyrimidines
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Outcome Assessment, Health Care
- Outcome and Process Assessment, Health Care
- Benzopyrans
- Flavonols
- Flavonoids
- Chromones
- Temozolomide
- Dasatinib
- Quercetin
- Observation
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Drug Therapy
- Watchful Waiting
- fisetin
Other Study ID Numbers
- MC230715 (Mayo Clinic)
- 23-008241 (Other Identifier: Mayo Clinic Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.