Actively Recruiting
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Led by Orbus Therapeutics, Inc. · Updated on 2025-06-25
66
Participants Needed
8
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of WHO Grade 4 glioblastoma, IDH-wildtype, or Grade 3 astrocytoma with IDH1 or 2 mutation and CDKN2A/B intact
- Completed external beam radiation therapy as standard care
- For glioblastoma patients: Received at least 80% of planned daily doses of temozolomide during chemoradiation
- For astrocytoma patients: Tolerated adjuvant temozolomide treatment through 2 to 4 cycles
- Adequate blood, kidney, liver, and other organ function based on tests
- Willingness to abstain from intercourse or use acceptable contraception
- If using corticosteroids, dose must be stable or decreasing
You will not qualify if you...
- Recent history of recurrent or metastatic cancer that could affect study results
- Prior systemic chemotherapy other than temozolomide during radiation or adjuvant temozolomide through up to 4 cycles
- Previous use of Optune treatment
- Active infection or serious ongoing medical illness
- Poorly controlled seizures
- Significant heart disease within 6 months before enrollment
- Poorly controlled diabetes
- Use of another investigational drug within 30 days before enrollment
AI-Screening
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Trial Site Locations
Total: 8 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Withdrawn
2
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
3
Columbia University Medical Center - Herbert Irving Pavilion
New York, New York, United States, 10032
Actively Recruiting
4
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
5
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
6
Brown University Health/Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
M
Monika Varga
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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