Phase
Condition
Brain Cancer
Astrocytoma
Neurofibromatosis
Treatment
Positron Emission Tomography
Fisetin
Biospecimen Collection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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):
≥ 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 Design
Connect with a study center
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.