Clinical Trials

Inclusion Criteria:

• Age ≥18 years

• Disease criteria

  • Prior diagnosis of a glioma treated with chemotherapy and/or radiation with stable disease based on RANO criteria

  • Must have IDH-mutant OR MGMT-methylated glioma

  • Patients with any radiographic evidence of residual disease are eligible 

• ECOG of 0, 1, or 2, and Karnofsky Performance Status >50 

• The following laboratory values obtained ≤15 days prior to registration to ensure adequate bone marrow and liver function.

  • Hemoglobin ≥9.0 g/dL

  • Absolute neutrophil count (ANC) ≥1500/mm

  • Platelet count ≥100,000/mm3 (without transfusion ≤7 days preceding lab assessment)

  • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 x ULN (or ≤5 x ULN for patients with liver involvement)

  • Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula

• Average QTc≤450 ms on triplicate 12 lead 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 (see Sections 6.0 and 14.0).

• Co-enrollment on the Neuro-Oncology biorepository (IRB12-003458) for collection of research blood and CSF samples.

• Provide written informed consent.

• Willingness to return to Mayo Clinic for follow-up

Exclusion Criteria:

• 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

• 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: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/07/2024. Questions regarding updates should be directed to the study team contact.