Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

Description

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Conditions

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

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Study Overview

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Study Details

Study overview

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

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

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma

Condition
Glioblastoma, IDH-wildtype
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

New York

Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States, 10032

Durham

Duke University, Durham, North Carolina, United States, 27710

Cleveland

The Cleveland Clinic, Cleveland, Ohio, United States, 44195

Providence

Lifespan Cancer Institute/Rhode Island Hospital, Providence, Rhode Island, United States, 02903

Houston

UT MD Anderson Cancer Center, Houston, Texas, United States, 77030

Salt Lake City

University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype per WHO 2021 tumor classification.
  • * Completed external beam radiation therapy per standard of care.
  • * Must have received at least 80% of planned daily doses of TMZ during chemoradiation.
  • * 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 for GBM other than temozolomide during external beam radiation therapy.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orbus Therapeutics, Inc.,

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

Study Record Dates

2024-12-15