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Eflornithine and Temozolomide for Newly Diagnosed Glioblastoma or Astrocytoma

This study is testing a combination of two drugs, eflornithine and temozolomide, for people newly diagnosed with glioblastoma (a type of brain cancer) or astrocytoma (another type of brain tumor). The main goal is to find the safest and most effective dose of eflornithine when given with temozolomide, and to see how well people tolerate this combination. Researchers will be looking for any side effects and how often they occur. To join, you must be at least 18 years old and have a specific diagnosis of glioblastoma (IDH-wildtype) or astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) and have completed radiation therapy. The study is currently recruiting up to 66 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It involves increasing doses of eflornithine combined with a standard dose of temozolomide, with up to 66 participants.
What's involved
Your participation could last up to approximately 104 weeks (about two years), including a screening period of up to 4 weeks and a treatment period of up to 104 weeks.
Compensation
Not stated in the trial record.
Follow-up
After your last treatment, there will be a follow-up visit 4 weeks later, and then long-term survival follow-up for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05879367

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Orbus Therapeutics, Inc.
~66 participants
Updated 2025-06-25 on ClinicalTrials.gov
What's tested:Eflornithine (Dose Level 1)Eflornithine (Dose Level 2)Eflornithine (Dose Level -1)Temozolomide

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Dose Limiting Toxicities
Measured over 8 weeks
+7 more outcomes measured

Conditions

Glioblastoma, IDH-wildtype
Glioblastoma
Glioblastoma Multiforme
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
GBM
Astrocytoma
Astrocytoma, IDH-Mutant

Explore related trials

AstrocytomaGlioblastoma

Where it's being run

8 sites across 8 states
Alabama1
Michigan1
New York1
North Carolina1
Ohio1
Rhode Island1
Texas1
Utah1

Study leadership

  • Howard Colman, MD, PhD · PRINCIPAL_INVESTIGATOR · Huntsman Cancer Institute

Who to contact

Monika Varga
[email protected]
6506569424
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Assessment of Dose Limiting Toxicities8 weeks

    Protocol Defined Dose Limiting Toxicities

  • Incidence of TEAEs All GradesFrom enrollment to the follow-up visit 4 weeks after end of treatment

    All Grades

  • Incidence of TEAEs Grade 3+From enrollment to the follow-up visit 4 weeks after end of treatment

    Grade 3+

  • Incidence of TEAEs SeriousFrom enrollment to the follow-up visit 4 weeks after end of treatment

    Serious

  • Incidence of TEAEs Leading to DiscontinuationFrom enrollment to the end of treatment

    Leading to Discontinuation

  • Vital Signs (Heart and Respiratory Rate)From enrollment to the follow-up visit 4 weeks after end of treatment

    Change from Baseline in Heart Rate and Respiratory Rate

  • Vital Signs (Blood Pressure)From enrollment to the follow-up visit 4 weeks after end of treatment

    Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure

  • Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory TestsFrom enrollment to the follow-up visit 4 weeks after end of treatment

    Lab abnormalities by CTCAE v5.0 Grade