MC230715 Pilot Study of the Mechanistic Feedback From CNS Tumors With Latent Residual Disease to Guide Individualized Therapies
Mayo Clinic
Summary
This early phase I trial tests the safety, side effects and how well medication combinations of dasatinib, quercetin, fisetin and temozolomide 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. Giving medication combinations of dasatinib, quercetin, fisetin and temozolomide may be safe, tolerable and/or effective in treating patients with previously treated glioma with residual disease.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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\…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and CSF sample collection
- DrugDasatinib
Given PO
- DrugFisetin
Given PO
- DrugFluorodopa F 18
Undergo 18F-DOPA-PET scan
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- OtherPatient Observation
Receive rest and take no treatment
- ProcedurePositron Emission Tomography
Undergo 18F-DOPA-PET scan
Location
- Mayo Clinic in RochesterRochester, Minnesota