Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
NCT ID: NCT02796261
Last Updated: 2022-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
343 participants
INTERVENTIONAL
2016-07-31
2023-06-30
Brief Summary
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Detailed Description
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Screening Period - A maximum screening duration of 4 weeks.
Treatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period - Up to approximately 36 months, or until patient death.
A total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Lomustine
Lomustine dosed every 6 weeks
Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Interventions
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Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Gd-contrast lesion margins are not clearly defined,
2. Gd-contrast lesions are only measurable in one dimension,
3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,
4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,
5. 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 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.
18 Years
ALL
No
Sponsors
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Orbus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
HCA Midwest Division
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
JFK Medical Center
Edison, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center, The Neurological Institute
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
The Cleveland Clinic, Richard E. Jacobs Health Center
Cleveland, Ohio, United States
OhioHealth Research and Innovation Institute
Columbus, Ohio, United States
Providence Brain & Spine Institute
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Hollings Cancer Center
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Oncology Austin Brain Tumor Center
Austin, Texas, United States
Neuro-Oncology Associates
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Swedish Health Services
Seattle, Washington, United States
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL De Mont-Godinne
Yvoir, Namur, Belgium
Tom Baker Cancer Center
Calgary, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Institut de Cancerologie de l'Ouest - Angers
Angers, , France
CHRU de Brest
Brest, , France
Hôpital Pierre Wertheimer - Hospices Civils de Lyon
Bron, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
Hôpital Roger Salengro
Lille, , France
Hôpital de la Timone
Marseille, , France
Hôpital Universitaire Pitié Salpêtrière
Paris, , France
Klinik und Poliklinik fur Neurologie der Universitat Regensburg
Regensburg, Bavaria, Germany
Heinrich-Heine-Universitat Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Fondazione IRCCS - Instituto Neurologico Carlo Besta
Milan, , Italy
Istituto Oncologico Veneto
Padua, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, , Italy
Sint Elisabeth Ziekenhuis
Tilburg, North Brabant, Netherlands
Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum Daniel den Hoed
Rotterdam, South Holland, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Edinburgh Cancer Centre - Western General Hospital
Edinburgh, , United Kingdom
Guy's Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Countries
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Other Identifiers
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OT-15-001
Identifier Type: -
Identifier Source: org_study_id
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