Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

About the study

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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 by hematology 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

Exclusion Criteria:

Recent history of recurrent or metastatic cancer that could confound response assessments
Prior systemic chemotherapy for GBM other than temozolomide during external beam radiation 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.