Clinical Trials

Inclusion Criteria:

• Age ≥18 years.

• Diagnosis of glioma and intention to treat with systemic therapy. NOTE: Patient may be enrolled following completion of surgery and/or radiation therapy for newly diagnosed or recurrent tumor. NOTE: Any number of prior recurrences is permitted. 

• Sufficient washout from prior systemic therapy at the time of registration: 

  • ≥Six weeks from last dose of nitrosourea or antiangiogenic.

  • ≥Four weeks from last dose of all other systemic therapy.

• ECOG Performance Status of 0, 1, or 2, AND Karnofsky Performance Status (KPS) of ≥ 60.

• Expected survival ≥6 months in the opinion of treatment team.

• Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations.

• The following laboratory values obtained ≤30 days prior to registration:

  • White blood cell (WBC) count ≥ 3,000

  • Absolute neutrophil count (ANC) ≥ 1,500

  • Platelet count ≥ 100,000 at baseline prior to systemic therapy initiation

  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN (≤5 x ULN for patients with baseline liver disease).

• Negative pregnancy test ≤8 days prior to registration for persons of childbearing potential only

• Provide written informed consent

• Ability to complete assessments and questionnaires by themselves or with assistance

Exclusion Criteria:

• Pregnant or nursing, imprisoned, or lacking capacity for understanding.

• Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings.

• Currently on tumor-directed systemic therapy.

• Any of the following cardiac criteria:

  • Marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >480 milliseconds (ms) (CTCAE Grade 1) using Fredericia’s QT correction formula

  • History of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

  • Use of concomitant medications that prolong the QT/QTc interval

  • History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

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

Eligibility last updated 03/10/2025. Questions regarding updates should be directed to the study team contact.