Last updated on September 2018

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


Brief description of study

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 Study 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 24 months.

A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

Clinical Study Identifier: NCT02796261

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Burt Nabors, MD

University of Alabama at Birmingham
Birmingham, AL United States
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Surasak Phuphanich, MD

Saint Joseph's Hospital and Medical Center
Phoenix, AZ United States
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Richard Green, MD

Kaiser Permanente
Los Angeles, CA United States
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Naveed Wagle, MD

University of Southern California Norris Comprehensive Cancer Center
Los Angeles, CA United States
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Timothy Cloughesy, MD

University of California Los Angeles - Jonsson Comprehensive Cancer Center
Los Angeles, CA United States
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Daniela Bota, MD

University of California Irvine Medical Center
Orange, CA United States
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Piia Thomas, MD

Kaiser Permanente Center
Redwood City, CA United States
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Enrico Lallana, MD

Kaiser Permanente
Sacramento, CA United States
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David Piccioni, MD

UCSD Moores Cancer Center
San Diego, CA United States
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Nicholas Butowski, MD

University of California San Francisco Medical Center
San Francisco, CA United States
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Santosh Kesari, MD

John Wayne Cancer Institute
Santa Monica, CA United States
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Michael Pearlman, MD

Colorado Neurological Institute
Englewood, CO United States
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Marietta Franco, MS

Boca Raton Regional Hospital, Eugene M. & Christine E. Lynn Cancer Institute
Boca Raton, FL United States
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Marietta Franco, MS

The University of Florida Health System - UF Health Neurosurgery
Gainesville, FL United States
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Peter Forsyth, MD

University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Tampa, FL United States
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Erin Dunbar, MD

Piedmont Physicians Neuro-Oncology
Atlanta, GA United States
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Priya Kumthekar, MD

Northwestern University
Chicago, IL United States
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Sean Grimm, MD

Northwestern Medicine CDH Cancer Center
Warrenville, IL United States
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Varun Monga, MD

The University of Iowa
Iowa City, IA United States
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John Villano, MD

University of Kentucky Chandler Medical Center
Lexington, KY United States
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Renato LaRocca, MD

Norton Cancer Institute - Louisville
Louisville, KY United States
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Aaron Mammoser, MD

Louisiana State University Health Sciences Center New Orleans
New Orleans, LA United States
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Devon Evans, MD

Maine Center for Cancer Medicine and Blood Disorders
Scarborough, ME United States
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Tracy Batchelor, MD

Massachusetts General Hospital
Boston, MA United States
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Eric Wong, MD

Beth Israel Deaconess Medical Center
Boston, MA United States
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Patrick Wen, MD

Dana Farber Cancer Institute, Brigham and Women's Hospital
Boston, MA United States
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Tobias Walbert, MD

Henry Ford Hospital
Detroit, MI United States
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Sani Kizilbash, MD

Mayo Clinic Minnesota
Rochester, MN United States
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Amandeep Kalra, MD

HCA Midwest Division
Kansas City, MO United States
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Marietta Franco, MS

Dent Neurologic Institute
Buffalo, NY United States
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Teri Kreisl, MD

Columbia University Medical Center, The Neurological Institute
New York, NY United States
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Simon Khagi, MD

University of North Carolina - Chapel Hill
Chapel Hill, NC United States
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Annick Desjardins, MD

Duke University Medical Center
Durham, NC United States
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Roy Strowd, MD

Wake Forest University Health Sciences
Winston-Salem, NC United States
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David Peereboom, MD

The Cleveland Clinic, Richard E. Jacobs Health Center
Cleveland, OH United States
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Marietta Franco, MS

Penn State Milton S. Hershey Medical Center
Hershey, PA United States
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Lyndon Kim, MD

Thomas Jefferson University Hospital
Philadelphia, PA United States
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Scott Lindhorst, MD

Medical University of South Carolina, Hollings Cancer Center
Charleston, SC United States
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Paul Moots, MD

Vanderbilt University
Nashville, TN United States
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Morris Groves, MD

Texas Oncology Austin Brain Tumor Center
Austin, TX United States
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Karen Fink, MD

Neuro-Oncology Associates
Dallas, TX United States
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Rebecca Harrison, MD

MD Anderson Cancer Center
Houston, TX United States
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Howard Colman, MD

University of Utah
Salt Lake City, UT United States
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Tara Benkers, MD

Swedish Health Services
Seattle, WA United States
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Hendrikus Krouwer, MD

Waukesha Memorial Hospital
Waukesha, WI United States
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Marietta Franco, MS

Universitair Ziekenhuis Antwerpen
Edegem, Belgium
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Paul Clement, MD

Universitair Ziekenhuis Leuven
Leuven, Belgium
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Lionel D'Hondt, MD

Cliniques Universitaires UCL De Mont-Godinne
Yvoir, Belgium
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Luc Verbeke, MD

Onze Lieve Vrouwziekenhuis Aalst
Aalst, Belgium
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Antje Wick, MD

Universtaetsklinikum Heidelberg - Neurologische Klinik
Heidelberg, Germany
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Martin Uhl, MD

Universtaetsklinikum Erlangen - Neurologische Klinik
Erlangen, Germany
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Peter Hau, MD

Klinik und Poliklinik fur Neurologie der Universitat Regensburg
Regensburg, Germany
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Oliver Baehr, MD

Johnn-Wofgang-Goethe-Universitat Frankfurt
Frankfurt, Germany
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Marietta Franco, MS

Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III
Bonn, Germany
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Martin Glas, MD

Universit tsklinikum Essen
Essen, Germany
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Martin Misch, MD

Charite Universit tsmedizin Berlin
Berlin, Germany
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Marietta Franco, MS

Ruhr-Universitaet Bochum - Knappschaftskrankenhaus Bochum-Langendreer - Neurologische
Bochum, Germany
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Manfred Westphal, MD

Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
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Marietta Franco, MS

Universtaetsklinikum Giessen und Marburg GmbH - Marburg - Neurologische Klinik
Marburg, Germany
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Marietta Franco, MS

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Oncohematology IRST Cesena
Cesena, Italy
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Gaetano Finocchiaro, MD

Fondazione IRCCS - Instituto Neurologico Carlo Besta
Milano, Italy
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Giuseppe Lombardi, MD

Istituto Oncologico Veneto
Padova, Italy
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Marietta Franco, MS

Istituto Nazionale dei Tumori Regina Elena - IRE
Roma, Italy
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Marietta Franco, MS

Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Siena, Italy
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Riccardo Soffietti, MD

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, Italy
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Laurens Beerepoot, MD

Sint Elisabeth Ziekenhuis
Tilburg, Netherlands
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Myra Van Linde, MD

Vrije Universiteit Medisch Centrum (VUMC)
Amsterdam, Netherlands
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Filip De Vos, MD

Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
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Nina Paleologos, MD

Advocate Lutheran General Hospital
Park Ridge, IL United States
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Mohamed Hamza, MD

OhioHealth Research and Innovation Institute
Columbus, OH United States
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Jacob Easaw, MD

Cross Cancer Institute
Calgary, AB Canada
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Gloria Urgoiti, MD

Tom Baker Cancer Center
Calgary, AB Canada
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Marshall Pitz, MD

CancerCare Manitoba
Winnipeg, MB Canada
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Garth Nicholas, MD

Ottawa Hospital
Ottawa, ON Canada
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James Perry, MD

Sunnybrook Research Institute
Toronto, ON Canada
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Martin Van den Bent, MD

Erasmus Medisch Centrum Daniel den Hoed
Rotterdam, Netherlands
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Christopher Duma, MD

Hoag Memorial Hospital Presbyterian
Newport Beach, CA United States
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Douglas Ney, MD

University of Colorado
Aurora, CO United States
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Kurt Jaeckle, MD

Mayo Clinic - Florida
Jacksonville, FL United States
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Alfredo Voloschin, MD

Winship Cancer Institute
Atlanta, GA United States
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Milan Chheda, MD

Washington University
Saint Louis, MO United States
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Joseph Landolfi, MD

JFK Medical Center
Edison, NJ United States
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Andrew Chi, MD

NYU Langone Health, Perlmutter Cancer Center
New York, NY United States
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Ricky Chen, MD

Providence Brain & Spine Institute
Portland, OR United States
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Arati Desai, MD

University of Pennsylvania
Philadelphia, PA United States
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Ekokobe Fonkem, MD

Baylor Scott & White Medical Center - Temple
Temple, TX United States
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Warren Mason, MD

Princess Margaret Cancer Center
Toronto, ON Canada
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Kevin Petrecca, MD

Montreal Neurological Institute and Hospital
Montréal, QC Canada
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Michael Sabel, MD

Heinrich-Heine-Universitat Duesseldorf
Düsseldorf, Germany
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Marietta Franco, MS

Universtatsklinikum Koln Klinik und Poliklinik fur Neurologie
Köln, Germany
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Marietta Franco, MS

Universit tsklinik Leipzig - Medizinische Klinik und Poliklinik I Klinik f r Strahlentherapie
Leipzig, Germany
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