Combining eflornithine and temozolomide for newly diagnosed glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional phase 1 trial aims to determine the recommended phase 2 dose of eflornithine when used in combination with temozolomide for patients with newly diagnosed glioblastoma. The study employs a dose escalation design, where patients will receive escalating doses of eflornithine alongside a standard dose of temozolomide. Following the dose escalation, an expansion cohort will further assess the safety and preliminary efficacy of the combination at the recommended dose. Participants will be monitored over a total duration of up to 56 weeks, including treatment and follow-up periods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Columbia University Medical Center - Herbert Irving Pavilion
  New York, New York, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• The Cleveland Clinic
  Cleveland, Ohio, United States Recruiting
• Brown University Health/Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting
• UT MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Howard Colman, MD, PhD — Huntsman Cancer Institute
• Study coordinator: Monika Varga
• Email: monika.varga@orbustherapeutics.com
• Phone: 6506569424

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gene therapy combined with radiotherapy for brain tumors

  This study is testing a new gene therapy combined with targeted radiation to see if it can safely help people with recurrent high-grade brain tumors.

  Recruiting Phase 1 Henry Ford Health System · Detroit, Michigan · NCT05686798

• Infusion of Bevacizumab with Chemotherapy and Radiation for Newly Diagnosed Glioblastoma

  This study is testing if adding a special infusion of Bevacizumab to standard chemotherapy and radiation can help people with newly diagnosed glioblastoma live longer and feel better.

  Recruiting Phase 3 Northwell Health · New York, New York · NCT05271240

• LMP744 (an indenoisoquinolone) for people with recurrent glioblastoma

  This trial will test whether the drug LMP744 can shrink tumors or slow progression in adults whose glioblastoma has returned after prior treatment.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07416188

• Neoadjuvant radiochemotherapy for glioblastoma treatment

  This study is testing a new combination of radiation and chemotherapy before surgery to see if it helps people with glioblastoma feel better and live longer compared to standard treatment.

  Recruiting Phase 1 Hospital San Carlos, Madrid · Madrid · NCT06418113

• Comparing surgery and best treatment for recurrent glioblastoma

  This study is testing whether surgery or the best available treatment helps people with recurring glioblastoma feel better and live longer.

  Recruiting at 6 sites Erasmus Medical Center · San Francisco, California and 7 other locations · NCT06283927

• Comparing palliative care and surgery for high-grade glioma patients

  This study is testing whether palliative care or surgery helps people with high-grade glioma live longer and feel better.

  Recruiting at 6 sites Erasmus Medical Center · San Francisco, California and 7 other locations · NCT06146738

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.