RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-label, Phase 1b Study to Evaluate the Safety and Tolerability of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Quick Facts

Study Start:2023-07-24

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05879367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Monika Varga

CONTACT

6506569424

monika.varga@orbustherapeutics.com

Principal Investigator

Howard Colman, MD, PhD

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute/ University of Utah

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, 10032

United States

Duke University

Durham, North Carolina, 27710

United States

The Cleveland Clinic

Cleveland, Ohio, 44195

United States

Brown University Health/Rhode Island Hospital

Providence, Rhode Island, 02903

United States

UT MD Anderson Cancer Center

Houston, Texas, 77030

United States

University of Utah, Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Orbus Therapeutics, Inc.

Howard Colman, MD, PhD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute/ University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-24

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

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