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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07025226
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Dasatinib — DRUG
    Given PO
  • Fisetin — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Patient Observation — OTHER
    Receive rest and take no treatment
  • Positron Emission Tomography — PROCEDURE
    Undergo amino acid PET scan (optional)
  • Quercetin — DRUG
    Given PO
  • Temozolomide — DRUG
    Given PO
  • Topoisomerase-1 Inhibitor LMP744 — DRUG
    Given IV
  • Single Agent Therapy — DRUG
    Given autologous TLPO vaccine ID

Study Details

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.

Key Dates

First listed
Jun 17, 2025
Start date
Aug 12, 2025
Status verified
Jun 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Completion of 3 cycles [ Time Frame: Up to 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Terry Burns, MD, PhD (PRINCIPAL_INVESTIGATOR)

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