Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02796261 : Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
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.

- Unequivocal evidence of first AA tumor progression or recurrence ? 3 months prior to
randomization based on MRI criteria for tumor progression using enlarging Gd-contrast
enhancement and/or T2 hyperintensity. Patients with non-measurable Gd contrast
enhancing tumors will only be eligible if there is no necrosis seen on MRI and/or
histopathological confirmation of AA per standard of care procedures is obtained.

- First tumor progression or recurrence following surgical resection or biopsy, if
resection is not feasible, EBRT and temozolomide chemotherapy.

- 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.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02796261      |      Link to official Clinicaltrials.gov listing
Locations
Edegem, Antwerpen
Belgium

Facility: Universitair Ziekenhuis Antwerpen
Investigator:
Contact: Pol Specenier, MD Phone: +3238214014
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Leuven, Flemish Brabant
Belgium

Facility: Universitair Ziekenhuis Leuven
Investigator:
Contact: Paul Clement, MD Phone: +3216346900
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Yvoir, Namur
Belgium

Facility: Cliniques Universitaires UCL De Mont-Godinne
Investigator:
Contact: Lionel D'Hondt, MD Phone: +3281423858
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Aalst, Oost-Vlaanderen
Belgium

Facility: Onze Lieve Vrouwziekenhuis Aalst
Investigator:
Contact: Luc Verbeke, MD Phone: +3253724479
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Calgary, Alberta
Canada

Facility: Cross Cancer Institute
Investigator:
Contact: Jacob Easaw, MD Phone: 780-432-8824
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Calgary, Alberta
Canada

Facility: Tom Baker Cancer Center
Investigator:
Contact: Gloria Urgoiti, MD Phone: 403-521-3912
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Winnipeg, Manitoba
Canada

Facility: CancerCare Manitoba
Investigator:
Contact: Marshall Pitz, MD Phone: 204-787-8642
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Ottawa, Ontario
Canada

Facility: Ottawa Hospital
Investigator:
Contact: Garth Nicholas, MD Phone: 613-737-7700 ext. 70179
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Toronto, Ontario
Canada

Facility: Sunnybrook Research Institute
Investigator:
Contact: James Perry, MD Phone: 416-480-4766
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Montréal, Quebec
Canada

Facility: Montreal Neurological Institute and Hospital
Investigator:
Contact: Kevin Petrecca, MD Phone: 514-398-2591
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Berlin,
Germany

Facility: Charite Universitätsmedizin Berlin
Investigator:
Contact: Martin Misch, MD Phone: +4930450660097
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Bochum,
Germany

Facility: Ruhr-Universitaet Bochum - Knappschaftskrankenhaus Bochum-Langendreer - Neurologische
Investigator:
Contact: Uwe Schlegel, MD Phone: +492342993701
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Hamburg,
Germany

Facility: Universitaetsklinikum Hamburg-Eppendorf
Investigator:
Contact: Manfred Westphal, MD Phone: +49040741053750
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Marburg,
Germany

Facility: Universtaetsklinikum Giessen und Marburg GmbH - Marburg - Neurologische Klinik
Investigator:
Contact: Herwig Strik, MD Phone: +4964215865179
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Heidelberg, Baden-Wuerttemberg
Germany

Facility: Universtaetsklinikum Heidelberg - Neurologische Klinik
Investigator:
Contact: Antje Wick, MD Phone: +4906221567075
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Erlangen, Bayern
Germany

Facility: Universtaetsklinikum Erlangen - Neurologische Klinik
Investigator:
Contact: Martin Uhl, MD Phone: +4991318534640
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Regensburg, Bayern
Germany

Facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg
Investigator:
Contact: Peter Hau, MD Phone: +4909419418083
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Frankfurt, Hessen
Germany

Facility: Johnn-Wofgang-Goethe-Universitat Frankfurt
Investigator:
Contact: Oliver Baehr, MD Phone: +49069630187711
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Bonn, Nordrhein-Westfalen
Germany

Facility: Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III
Investigator:
Contact: Ulrich Herrlinger, MD Phone: +4902282875736
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Düsseldorf, Nordrhein-Westfalen
Germany

Facility: Heinrich-Heine-Universitat Duesseldorf
Investigator:
Contact: Michael Sabel, MD Phone: +4902118117937
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Essen, Nordrhein-Westfalen
Germany

Facility: Universitätsklinikum Essen
Investigator:
Contact: Martin Glas, MD Phone: +492017236513
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Köln, Nordrhein-Westfalen
Germany

Facility: Universtatsklinikum Koln Klinik und Poliklinik fur Neurologie
Investigator:
Contact: Pantelis Stavrinou, MD Phone: +00492214784572
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Cesena,
Italy

Facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Oncohematology IRST Cesena
Investigator:
Contact: Toni Ibrahim, MD Phone: +390543739100
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Milano,
Italy

Facility: Fondazione IRCCS - Instituto Neurologico Carlo Besta
Investigator:
Contact: Gaetano Finocchiaro, MD Phone: 39 02-2394-2454
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Padova,
Italy

Facility: Istituto Oncologico Veneto
Investigator:
Contact: Giuseppe Lombardi, MD Phone: +390498215910
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Roma,
Italy

Facility: Istituto Nazionale dei Tumori Regina Elena - IRE
Investigator:
Contact: Carmine Carapella, MD Phone: +0652665595
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Siena,
Italy

Facility: Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte
Investigator:
Contact: Michele Maio, MD Phone: +390577586335
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Torino,
Italy

Facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Investigator:
Contact: Riccardo Soffietti, MD Phone: +390116334904
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Utrecht,
Netherlands

Facility: Universitair Medisch Centrum Utrecht
Investigator:
Contact: Filip De Vos, MD Phone: +31243610353
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Tilburg, Noord-Brabant
Netherlands

Facility: Sint Elisabeth Ziekenhuis
Investigator:
Contact: Laurens Beerepoot, MD Phone: +31135393069
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Amsterdam, Noord-Holland
Netherlands

Facility: Vrije Universiteit Medisch Centrum (VUMC)
Investigator:
Contact: Myra Van Linde, MD Phone: +31204444321
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Rotterdam, Zuid-Holland
Netherlands

Facility: Erasmus Medisch Centrum Daniel den Hoed
Investigator:
Contact: Martin Van den Bent, MD Phone: +31107041415
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Birmingham, Alabama
Facility: University of Alabama at Birmingham
Investigator:
Contact: Burt Nabors, MD Phone: 205-934-1813
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Phoenix, Arizona
Facility: Saint Joseph's Hospital and Medical Center
Investigator:
Contact: Surasak Phuphanich, MD Phone: 602-406-6262
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Los Angeles, California
Facility: Kaiser Permanente
Investigator:
Contact: Richard Green, MD Phone: 323-783-4200
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Los Angeles, California
Facility: University of Southern California Norris Comprehensive Cancer Center
Investigator:
Contact: Naveed Wagle, MD Phone: 323-865-3977
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Los Angeles, California
Facility: University of California Los Angeles - Jonsson Comprehensive Cancer Center
Investigator:
Contact: Timothy Cloughesy, MD Phone: 310-825-5321
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Orange, California
Facility: University of California Irvine Medical Center
Investigator:
Contact: Daniela Bota, MD Phone: 714-456-7032
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Redwood City, California
Facility: Kaiser Permanente Center
Investigator:
Contact: Piia Thomas, MD Phone: 650-299-3690
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Sacramento, California
Facility: Kaiser Permanente
Investigator:
Contact: Enrico Lallana, MD Phone: 916-973-5490
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San Diego, California
Facility: UCSD Moores Cancer Center
Investigator:
Contact: David Piccioni, MD Phone: 858-822-7778
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San Francisco, California
Facility: University of California San Francisco Medical Center
Investigator:
Contact: Nicholas Butowski, MD Phone: 415-353-7500
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Santa Monica, California
Facility: John Wayne Cancer Institute
Investigator:
Contact: Santosh Kesari, MD Phone: 858-822-7524
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Englewood, Colorado
Facility: Colorado Neurological Institute
Investigator:
Contact: Michael Pearlman, MD Phone: 303-781-4485
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Boca Raton, Florida
Facility: Boca Raton Regional Hospital, Eugene M. & Christine E. Lynn Cancer Institute
Investigator:
Contact: Sajeel Chowdhary, MD Phone: 561-955-3481
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Gainesville, Florida
Facility: The University of Florida Health System - UF Health Neurosurgery
Investigator:
Contact: Ashley Ghiaseddin, MD Phone: 352-273-9000
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Tampa, Florida
Facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute
Investigator:
Contact: Peter Forsyth, MD Phone: 813-745-4673
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Atlanta, Georgia
Facility: Piedmont Physicians Neuro-Oncology
Investigator:
Contact: Erin Dunbar, MD Phone: 404-605-2050
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Chicago, Illinois
Facility: Northwestern University
Investigator:
Contact: Priya Kumthekar, MD Phone: 312-503-1818
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Park Ridge, Illinois
Facility: Advocate Lutheran General Hospital
Investigator:
Contact: Nina Paleologos, MD Phone: 847-723-4500
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Warrenville, Illinois
Facility: Northwestern Medicine CDH Cancer Center
Investigator:
Contact: Sean Grimm, MD Phone: 630-352-5450
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Iowa City, Iowa
Facility: The University of Iowa
Investigator:
Contact: Varun Monga, MD Phone: 319-353-8775
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Lexington, Kentucky
Facility: University of Kentucky Chandler Medical Center
Investigator:
Contact: John Villano, MD Phone: 859-257-3379
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Louisville, Kentucky
Facility: Norton Cancer Institute - Louisville
Investigator:
Contact: Renato LaRocca, MD Phone: 502-561-8200
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New Orleans, Louisiana
Facility: Louisiana State University Health Sciences Center New Orleans
Investigator:
Contact: Aaron Mammoser, MD Phone: 504-568-2698
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Scarborough, Maine
Facility: Maine Center for Cancer Medicine and Blood Disorders
Investigator:
Contact: Devon Evans, MD Phone: 207-396-7600
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Boston, Massachusetts
Facility: Beth Israel Deaconess Medical Center
Investigator:
Contact: Eric Wong, MD Phone: 617-667-1665
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Boston, Massachusetts
Facility: Dana Farber Cancer Institute, Brigham and Women's Hospital
Investigator:
Contact: Patrick Wen, MD Phone: 617-632-2166
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Detroit, Michigan
Facility: Henry Ford Hospital
Investigator:
Contact: Tobias Walbert, MD Phone: 313-916-2723
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Rochester, Minnesota
Facility: Mayo Clinic Minnesota
Investigator:
Contact: Sani Kizilbash, MD Phone: 507-293-0494
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Kansas City, Missouri
Facility: HCA Midwest Division
Investigator:
Contact: Amandeep Kalra, MD Phone: 816-698-7000
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New York, New York
Facility: Columbia University Medical Center, The Neurological Institute
Investigator:
Contact: Teri Kreisl, MD Phone: 212-342-0571
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Chapel Hill, North Carolina
Facility: University of North Carolina - Chapel Hill
Investigator:
Contact: Simon Khagi, MD Phone: 919-966-4786
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Durham, North Carolina
Facility: Duke University Medical Center
Investigator:
Contact: Annick Desjardins, MD Phone: 919-668-2993
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Winston-Salem, North Carolina
Facility: Wake Forest University Health Sciences
Investigator:
Contact: Roy Strowd, MD Phone: 336-713-6979
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Cleveland, Ohio
Facility: The Cleveland Clinic, Richard E. Jacobs Health Center
Investigator:
Contact: David Peereboom, MD Phone: 216-445-6068
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Columbus, Ohio
Facility: OhioHealth Research and Innovation Institute
Investigator:
Contact: Mohamed Hamza, MD Phone: 614-566-4200
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Hershey, Pennsylvania
Facility: Penn State Milton S. Hershey Medical Center
Investigator:
Contact: Dawit Aregawi, MD Phone: 717-531-3828
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Philadelphia, Pennsylvania
Facility: Thomas Jefferson University Hospital
Investigator:
Contact: Lyndon Kim, MD Phone: 215-955-7000
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Charleston, South Carolina
Facility: Medical University of South Carolina, Hollings Cancer Center
Investigator:
Contact: Scott Lindhorst, MD Phone: 843-792-2568
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Nashville, Tennessee
Facility: Vanderbilt University
Investigator:
Contact: Paul Moots, MD
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Austin, Texas
Facility: Texas Oncology Austin Brain Tumor Center
Investigator:
Contact: Morris Groves, MD Phone: 512-421-4100
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Dallas, Texas
Facility: Neuro-Oncology Associates
Investigator:
Contact: Karen Fink, MD Phone: 214-820-8690
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Houston, Texas
Facility: MD Anderson Cancer Center
Investigator:
Contact: Marta Penas-Prado, MD Phone: 713-745-2164
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Salt Lake City, Utah
Facility: University of Utah
Investigator:
Contact: Howard Colman, MD Phone: 801-581-7200
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Seattle, Washington
Facility: Swedish Health Services
Investigator:
Contact: Jerome Graber, MD Phone: 206-320-2300
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Waukesha, Wisconsin
Facility: Waukesha Memorial Hospital
Investigator:
Contact: Hendrikus Krouwer, MD Phone: 262-928-2570
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