Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
Glioblastoma, IDH-wildtype, Glioblastoma, Glioblastoma Multiforme
About this trial
This is an interventional treatment trial for Glioblastoma, IDH-wildtype
Eligibility 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: 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.
Sites / Locations
- Henry Ford HospitalRecruiting
- Columbia University Medical Center - Herbert Irving PavilionRecruiting
- The Cleveland ClinicRecruiting
- Lifespan Cancer Institute/Rhode Island HospitalRecruiting
- UT MD Anderson Cancer CenterRecruiting
- University of Utah, Huntsman Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Eflornithine Dose Level 1 + Temozolomide
Eflornithine Dose Level 2 + Temozolomide
Eflornithine Dose Level -1 + Temozolomide