Spots Global Cancer Trial Database for Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
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Trial Identification
Brief Title: Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Official Title: A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
Study ID: NCT02796261
Study Description
Brief Summary: 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.
Detailed Description: This study will consist of 4 study periods of up to 50 months in total, consisting of: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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, Montréal, 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, Bayern, Germany
Heinrich-Heine-Universitat Duesseldorf, Düsseldorf, Nordrhein-Westfalen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Fondazione IRCCS - Instituto Neurologico Carlo Besta, Milano, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino, , Italy
Sint Elisabeth Ziekenhuis, Tilburg, Noord-Brabant, Netherlands
Vrije Universiteit Medisch Centrum (VUMC), Amsterdam, Noord-Holland, Netherlands
Erasmus Medisch Centrum Daniel den Hoed, Rotterdam, Zuid-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
Contact Details
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