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

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