Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Launched by ORBUS THERAPEUTICS, INC. · May 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for patients who have just been diagnosed with glioblastoma, a type of brain cancer. The researchers want to find out the best dose of a medication called eflornithine when used together with another drug called temozolomide. They will also look at how safe this combination is for patients. The trial is currently recruiting participants aged between 65 to 74 who have recently completed radiation therapy and have been treated with temozolomide.

To be eligible for this study, participants must have a specific type of glioblastoma and meet certain health criteria, such as having stable organ function and being on a controlled dose of steroids if they are taking them. People with other recent cancers, infections, or serious medical issues may not be able to participate. Those who join the trial can expect to receive close monitoring and support throughout the study, helping researchers learn more about this potential new treatment for glioblastoma.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.
• • Completed external beam radiation therapy per standard of care.
• • Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.
• • 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 other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).
• • 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.