Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma (NCT05879367)
An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (8 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Henry Ford Hospital — Detroit, Michigan
- Columbia University Medical Center - Herbert Irving Pavilion — New York, New York
- Duke University — Durham, North Carolina
- The Cleveland Clinic — Cleveland, Ohio
- Brown University Health/Rhode Island Hospital — Providence, Rhode Island
- UT MD Anderson Cancer Center — Houston, Texas
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (650) 656-9424
Email: monika.varga@orbustherapeutics.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Glioblastoma, IDH-wildtype
- The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma — San Francisco, California
- Continuous Glucose Monitoring for the Management of Hyperglycemia in Patients With Glioblastoma — Phoenix, Arizona
- GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma — Rochester, Minnesota
- WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma — Chicago, Illinois
- Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma — Scottsdale, Arizona
Explore by condition: All Glioblastoma, IDH-wildtype clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.