Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Status unconfirmed · Phase 3

Conditions studied: Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma

In brief

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

Key facts

Study ID

NCT02796261

Run by

Orbus Therapeutics, Inc.

People needed

343

Starts

2016-07-01

Expected to finish

2023-06-01

Last updated by the study team

2022-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
• Surgical or biopsy-proven diagnosis of WHO grade 3 AA.
• First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:
• Gd-contrast lesion margins are not clearly defined,
• Gd-contrast lesions are only measurable in one dimension,
• Gd-contrast lesion has two perpendicular diameters less than 10 mm,
• Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
• Recent histopathological confirmation of WHO grade 3 AA
• Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.
• Completion of EBRT ≥ 6 months prior to randomization.
• A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.
• Karnofsky Performance Status (KPS) score of ≥ 70.

You may not qualify if…

• Patients who meet any of the following exclusion criteria are not eligible for study participation:
• MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.
• Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.
• Prior systemic therapy for recurrence of AA.
• Presence of extracranial or leptomeningeal disease.
• Prior lomustine use.
• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.
• Pregnant or breastfeeding.

Where it is running

• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Kaiser Permanente — Los Angeles, California, United States
• University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Kaiser Permanente Center — Redwood City, California, United States
• Kaiser Permanente — Sacramento, California, United States
• UCSD Moores Cancer Center — San Diego, California, United States
• University of California San Francisco Medical Center — San Francisco, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Piedmont Physicians Neuro-Oncology — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Northwestern Medicine CDH Cancer Center — Warrenville, Illinois, United States
• The University of Iowa — Iowa City, Iowa, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Norton Cancer Institute - Louisville — Louisville, Kentucky, United States
• Louisiana State University Health Sciences Center New Orleans — New Orleans, Louisiana, United States
• Maine Center for Cancer Medicine and Blood Disorders — Scarborough, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute, Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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