Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients (STELLAR)
Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma
About this trial
This is an interventional treatment trial for Anaplastic Astrocytoma focused on measuring Anaplastic Astrocytoma, Grade 3 Glioma, Glioma, Eflornithine, Brain Cancer, Brain Tumor, Neuro-oncology, Progressive Anaplastic Astrocytoma, Recurrent Anaplastic Astrocytoma, Progressive Glioma, Recurrent Glioma, Malignant Glioma, Progressive Brain Tumor, Recurrent Brain Tumor
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Sites / Locations
- University of Alabama at Birmingham
- Saint Joseph's Hospital and Medical Center
- Kaiser Permanente
- University of Southern California Norris Comprehensive Cancer Center
- University of California Irvine Medical Center
- Kaiser Permanente Center
- Kaiser Permanente
- UCSD Moores Cancer Center
- University of California San Francisco Medical Center
- John Wayne Cancer Institute
- University of Colorado
- University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
- Piedmont Physicians Neuro-Oncology
- Winship Cancer Institute
- Northwestern University
- Northwestern Medicine CDH Cancer Center
- The University of Iowa
- University of Kentucky Chandler Medical Center
- Norton Cancer Institute - Louisville
- Louisiana State University Health Sciences Center New Orleans
- Maine Center for Cancer Medicine and Blood Disorders
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute, Brigham and Women's Hospital
- Henry Ford Hospital
- Mayo Clinic Minnesota
- Saint Luke's Cancer Institute
- HCA Midwest Division
- Washington University
- JFK Medical Center
- Mount Sinai Hospital
- Columbia University Medical Center, The Neurological Institute
- University of North Carolina - Chapel Hill
- Duke University Medical Center
- Wake Forest University Health Sciences
- The Cleveland Clinic, Richard E. Jacobs Health Center
- OhioHealth Research and Innovation Institute
- Providence Brain & Spine Institute
- University of Pennsylvania
- Thomas Jefferson University Hospital
- Medical University of South Carolina, Hollings Cancer Center
- Vanderbilt University
- Texas Oncology Austin Brain Tumor Center
- Neuro-Oncology Associates
- MD Anderson Cancer Center
- University of Utah
- Swedish Health Services
- Universitair Ziekenhuis Leuven
- Cliniques Universitaires UCL De Mont-Godinne
- Tom Baker Cancer Center
- CancerCare Manitoba
- Ottawa Hospital
- Sunnybrook Research Institute
- Princess Margaret Cancer Center
- Montreal Neurological Institute and Hospital
- Institut de Cancerologie de l'Ouest - Angers
- CHRU de Brest
- Hôpital Pierre Wertheimer - Hospices Civils de Lyon
- Centre Jean Perrin
- Centre Georges François Leclerc
- Hôpital Roger Salengro
- Hôpital de la Timone
- Hôpital Universitaire Pitié Salpêtrière
- Klinik und Poliklinik fur Neurologie der Universitat Regensburg
- Heinrich-Heine-Universitat Duesseldorf
- Universitätsklinikum Essen
- Universitaetsklinikum Hamburg-Eppendorf
- Fondazione IRCCS - Instituto Neurologico Carlo Besta
- Istituto Oncologico Veneto
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
- Sint Elisabeth Ziekenhuis
- Vrije Universiteit Medisch Centrum (VUMC)
- Erasmus Medisch Centrum Daniel den Hoed
- Universitair Medisch Centrum Utrecht
- University Hospitals Birmingham NHS Foundation Trust
- Edinburgh Cancer Centre - Western General Hospital
- Guy's Hospital
- The Royal Marsden NHS Foundation Trust
- The Christie NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Eflornithine + Lomustine
Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Lomustine dosed every 6 weeks