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

PHASE3UnknownINTERVENTIONAL
Enrollment

343

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

June 30, 2023

Study Completion Date

June 30, 2023

Conditions
Anaplastic AstrocytomaRecurrent Anaplastic Astrocytoma
Interventions
DRUG

Eflornithine

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule

DRUG

Lomustine

Lomustine 90 mg/m2 administered orally once every 6 weeks

DRUG

Lomustine

Lomustine 110 mg/m2 administered orally once every 6 weeks

Trial Locations (79)

3000

Universitair Ziekenhuis Leuven, Leuven

5530

Cliniques Universitaires UCL De Mont-Godinne, Yvoir

10029

Mount Sinai Hospital, New York

10032

Columbia University Medical Center, The Neurological Institute, New York

10126

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette, Torino

13005

Hôpital de la Timone, Marseille

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

20133

Fondazione IRCCS - Instituto Neurologico Carlo Besta, Milan

20246

Universitaetsklinikum Hamburg-Eppendorf, Hamburg

21000

Centre Georges François Leclerc, Dijon

27157

Wake Forest University Health Sciences, Winston-Salem

27599

University of North Carolina - Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

29200

CHRU de Brest, Brest

29425

Medical University of South Carolina, Hollings Cancer Center, Charleston

30309

Piedmont Physicians Neuro-Oncology, Atlanta

30322

Winship Cancer Institute, Atlanta

33612

University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute, Tampa

35401

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University, Nashville

40202

Norton Cancer Institute - Louisville, Louisville

40225

Heinrich-Heine-Universitat Duesseldorf, Düsseldorf

40536

University of Kentucky Chandler Medical Center, Lexington

43214

OhioHealth Research and Innovation Institute, Columbus

44195

The Cleveland Clinic, Richard E. Jacobs Health Center, Cleveland

45147

Universitätsklinikum Essen, Essen

48202

Henry Ford Hospital, Detroit

49055

Institut de Cancerologie de l'Ouest - Angers, Angers

52242

The University of Iowa, Iowa City

55905

Mayo Clinic Minnesota, Rochester

59037

Hôpital Roger Salengro, Lille

60055

Northwestern Medicine CDH Cancer Center, Warrenville

60611

Northwestern University, Chicago

63011

Centre Jean Perrin, Clermont-Ferrand

63110

Washington University, St Louis

64111

Saint Luke's Cancer Institute, Kansas City

64132

HCA Midwest Division, Kansas City

69500

Hôpital Pierre Wertheimer - Hospices Civils de Lyon, Bron

70112

Louisiana State University Health Sciences Center New Orleans, New Orleans

75013

Hôpital Universitaire Pitié Salpêtrière, Paris

75246

Neuro-Oncology Associates, Dallas

77030

MD Anderson Cancer Center, Houston

78705

Texas Oncology Austin Brain Tumor Center, Austin

80045

University of Colorado, Aurora

84112

University of Utah, Salt Lake City

85013

Saint Joseph's Hospital and Medical Center, Phoenix

90027

Kaiser Permanente, Los Angeles

90033

University of Southern California Norris Comprehensive Cancer Center, Los Angeles

90404

John Wayne Cancer Institute, Santa Monica

92093

UCSD Moores Cancer Center, San Diego

92868

University of California Irvine Medical Center, Orange

93053

Klinik und Poliklinik fur Neurologie der Universitat Regensburg, Regensburg

94063

Kaiser Permanente Center, Redwood City

94143

University of California San Francisco Medical Center, San Francisco

95825

Kaiser Permanente, Sacramento

97225

Providence Brain & Spine Institute, Portland

98122

Swedish Health Services, Seattle

04074

Maine Center for Cancer Medicine and Blood Disorders, Scarborough

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Brigham and Women's Hospital, Boston

08820

JFK Medical Center, Edison

T2N 4N2

Tom Baker Cancer Center, Calgary

R3E 0V9

CancerCare Manitoba, Winnipeg

K1H 8L6

Ottawa Hospital, Ottawa

M4N 3M5

Sunnybrook Research Institute, Toronto

M5G2M9

Princess Margaret Cancer Center, Toronto

H3A 2B4

Montreal Neurological Institute and Hospital, Montreal

Unknown

Istituto Oncologico Veneto, Padua

5022 GC

Sint Elisabeth Ziekenhuis, Tilburg

1081 HV

Vrije Universiteit Medisch Centrum (VUMC), Amsterdam

3075 EA

Erasmus Medisch Centrum Daniel den Hoed, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Birmingham

EH4 2XU

Edinburgh Cancer Centre - Western General Hospital, Edinburgh

SE1 9RT

Guy's Hospital, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors
All Listed Sponsors
lead

Orbus Therapeutics, Inc.

INDUSTRY