An Early Phase 1 interventional study of Biospecimen Collection and Dasatinib in Glioma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Treatment
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.
1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.
This study's planned enrollment of 30 is close to the median of 32 across 1,065 interventional studies indexed under Glioma.
Browse Glioma studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Average corrected QT interval (QTc) ≤ 450 ms on triplicate 12 lead electrocardiogram (ECG) ≤ 29 days prior to registration
Inclusion Criteria - Monitoring Arm (Regimen 1 only):
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:
Participants who are unable to swallow tablets or who are at risk for impaired absorption of oral medication
Inability to undergo MRI scans
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:
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.
Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Other: Patient Observation · Procedure: Positron Emission Tomography
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.
Procedure: Biospecimen Collection · Drug: Dasatinib · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: Quercetin
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.
Procedure: Biospecimen Collection · Drug: Fisetin · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography
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.
Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: 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.
Procedure: Biospecimen Collection · Drug: Dasatinib · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: Quercetin · Drug: 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.
Procedure: Biospecimen Collection · Drug: Fisetin · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: Temozolomide
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.
Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Other: Patient Observation · Procedure: Positron Emission Tomography
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.
Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: Topoisomerase-1 Inhibitor LMP744
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.
Procedure: Biospecimen Collection · Procedure: Magnetic Resonance Imaging · Procedure: Positron Emission Tomography · Drug: Single Agent Therapy
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection, Sample Collection
Given PO
Also known as: BMS 354825, BMS-354825, BMS354825, Dasatinib Hydrate, Dasatinib Monohydrate, Sprycel
Given PO
Also known as: 3,3',4',7-Tetrahydroxyflavone, 7,3',4'-Flavon-3-ol
Undergo MRI
Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Receive rest and take no treatment
Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting
Undergo amino acid PET scan (optional)
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Given PO
Also known as: 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one, 2-(3,4-dihydroxyphenyl)-3,5,7-trihydroxy-chromen-4-one, C.I. Natural Yellow 10
Given PO
Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ
Given IV
Also known as: 308246-52-8, Indenoisoquinoline, LMP744, LMP-744, 5H-(1,3)Dioxolo(5,6)indeno(1,2-C)isoquinoline-5,12(6H)-dione, 6-(3-((2-Hydroxyethyl)amino)propyl)-2,3-dimethoxy-
Given autologous TLPO vaccine ID
Also known as: Drug Monotherapy, Monotherapy, Single Agent Treatment, Single Drug Therapy
Completion of 3 cycles
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.
Time frame: Up to 16 weeks
Turnaround time for scan and marker data
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.
Time frame: Up to 16 weeks (completion of 3 cycles)
Incidence of adverse events
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.
Time frame: Up to 3 years
Change in senescence-associated proteins
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%.
Time frame: Baseline; up to 3 years
Cell-free mitochondrial deoxyribonucleic acid (DNA)
Will evaluate the percentage change in cell-free mitochondrial DNA. An effective senolytics regimen will decrease cell-free mitochondrial DNA by at least 25%.
Time frame: Baseline; up to 3 years
2-Hydroxyglutarate (2-HG)
Will evaluate the percentage change in 2-HG.
Time frame: Baseline; up to 3 years
Amplified DNA junctions
Will evaluate the percentage change in amplified DNA junctions (if applicable).
Time frame: Baseline; up to 3 years
Volume of disease
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.
Time frame: Baseline; up to 3 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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