Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

Inclusion Criteria:

• Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification.
• Completed external beam radiation therapy per standard of care.
• Must have received at least 80% of planned daily doses of TMZ during chemoradiation.
• Adequate hematologic, renal, hepatic, and other organ function as indicated byhematology and serum chemistry testing.
• Willing to abstain from intercourse or use acceptable contraceptive methods.
• If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria:

• Recent history of recurrent or metastatic cancer that could confound responseassessments
• Prior systemic chemotherapy for GBM other than temozolomide during external beamradiation therapy.
• Prior Optune treatment.
• Active infection or serious intercurrent medical illness.
• Poorly controlled seizures.
• Significant cardiac disease within 6 months of enrollment.
• Poorly controlled diabetes.
• Use of another investigational agent within 30 days of enrollment.