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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02796261
Recruitment Status : Recruiting
First Posted : June 10, 2016
Last Update Posted : October 27, 2017
Information provided by (Responsible Party):
Orbus Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Recurrent Anaplastic Astrocytoma Drug: Eflornithine Drug: Lomustine Phase 3

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 24 months.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Eflornithine + Lomustine
Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks
Drug: Eflornithine
Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
Other Name: DFMO
Drug: Lomustine
Lomustine 90 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU
Active Comparator: Lomustine
Lomustine dosed every 6 weeks
Drug: Lomustine
Lomustine 110 mg/m2 administered orally once every 6 weeks
Other Names:
  • CCNU
  • CeeNU

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 4 years ]
  2. Objective response rate (ORR) [ Time Frame: 4 years ]

Other Outcome Measures:
  1. Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria [ Time Frame: 4 years ]
  2. OS rate at 18 months (OS-18) [ Time Frame: 18 months ]
  3. Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples [ Time Frame: 4 years ]
  4. Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]
  5. PK - Area under the curve (AUC) of eflornithine in plasma will be determined. [ Time Frame: 1 Month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02796261

Contact: Marietta Franco, MS 6504506634 marietta.franco@orbustherapeutics.com
Contact: Kathleen Villamejor, BS 6506569424 kathleen.villamejor@orbustherapeutics.com

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35401
Contact: Burt Nabors, MD    205-934-1813    bnabors@uab.edu   
Contact: Thiru Pillay    1 (205) 934-1432    tpillay@uabmc.edu   
United States, Arizona
Saint Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Surasak Phuphanich, MD    602-406-6262    surasak.phuphanich@dignityhealth.org   
Contact: Catherine Newitt    1 (602) 406-2141    catherine.newitt@dignityhealth.org   
United States, California
Kaiser Permanente Recruiting
Los Angeles, California, United States, 90027
Contact: Richard Green, MD    323-783-4200    richard.m.green@kp.org   
Contact: Sandra Baker    1 (310) 517-3896    sandra.t.baker@kp.org   
University of Southern California Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Naveed Wagle, MD    323-865-3977    naveed.wagle@med.usc.edu   
Contact: Aida Lozada    1 (323) 865-3980    aida.lozada@med.usc.edu   
University of California Los Angeles - Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Timothy Cloughesy, MD    310-825-5321    tcloughesy@mednet.ucla.edu   
Contact: Emese Filka    1 (310) 794-3521    efilka@mednet.ucla.edu   
University of California Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Daniela Bota, MD    714-456-7032    dbota@uci.edu   
Contact: Manisha Dandekar    714-456-6221    mdandeka@uci.edu   
Kaiser Permanente Center Recruiting
Redwood City, California, United States, 94063
Contact: Piia Thomas, MD    650-299-3690    piia.e.thomas@kp.org   
Contact: Isabella Hamilton    (510)891-5955    isabella.c.hamilton@kp.org   
Kaiser Permanente Recruiting
Sacramento, California, United States, 95825
Contact: Enrico Lallana, MD    916-973-5490    enrico.c.lallana@kp.org   
Contact: Renee Cunanan    1 (916) 973-4885    renee.j.cunanan@kp.org   
UCSD Moores Cancer Center Recruiting
San Diego, California, United States, 92093
Contact: David Piccioni, MD    858-822-7778    dpiccioni@mail.ucsd.edu   
Contact: Jennifer Moral    858-822-5377    jemoral@ucsd.edu   
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Nicholas Butowski, MD    415-353-7500    nicholas.butowski@ucsf.edu   
Contact: Eduardo Rodriguez Almaraz    (415) 514-5529    eduardo.rodriguez@ucsf.edu   
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Santosh Kesari, MD    858-822-7524    kesaris@jwci.org   
Contact: Naj Boucher    (310) 582-7460    Najee.Boucher@Providence.Org   
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
Contact: Michael Pearlman, MD    303-781-4485    mpearlman@carepointpc.com   
Contact: Tyler Irani    303 788 4010    tirani@thecni.org   
United States, Florida
Boca Raton Regional Hospital, Eugene M. & Christine E. Lynn Cancer Institute Recruiting
Boca Raton, Florida, United States, 33486
Contact: Sajeel Chowdhary, MD    561-955-3481    schowdhary@brrh.com   
Contact: Pilar Zuniga    1 (561) 955-3723    pzuniga@brrh.com   
The University of Florida Health System - UF Health Neurosurgery Recruiting
Gainesville, Florida, United States, 32610
Contact: Ashley Ghiaseddin, MD    352-273-9000    ashley.ghiaseddin@neurosurgery.ufl.edu   
Contact: Sonisha Warren    352-294-8737    sonisha.warren@neurosurgery.ufl.edu   
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Peter Forsyth, MD    813-745-4673    peter.forsyth@moffitt.org   
Contact: Ali Drury-Sibiga    813-745-5689    Ali.Drury-Sibiga@moffitt.org   
United States, Georgia
Piedmont Physicians Neuro-Oncology Recruiting
Atlanta, Georgia, United States, 30309
Contact: Erin Dunbar, MD    404-605-2050    erin.dunbar@piedmont.org   
Contact: Ali Arabnia    404-425-7943    Ali.Arabnia@piedmont.org   
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Priya Kumthekar, MD    312-503-1818    pkumthe2@nm.org   
Contact: Rachel Lukas    1 (312) 695-1371    rachel.lukas@northwestern.edu   
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
Contact: Nina Paleologos, MD    847-723-4500    nina.paleologos@advocatehealth.com   
Contact: Pauline Pastore    847-723-8237 ext 21-8237    Pauline.Pastore@advocatehealth.com   
Northwestern Medicine CDH Cancer Center Recruiting
Warrenville, Illinois, United States, 60055
Contact: Sean Grimm, MD    630-352-5450    sean.grimm@cadencehealth.org   
Contact: Juan Correa    630-315-8969    Juan.correa@nm.org   
United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Varun Monga, MD    319-353-8775    marian-andersen@uiowa.edu   
Contact: Karen Parrott    1 (319) 353-6347    karen-parrott@uiowa.edu   
United States, Kentucky
University of Kentucky Chandler Medical Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Villano, MD    859-257-3379    jlvillano@uky.edu   
Contact: Caressa Colburn    859-257-4406    caressa.colburn@uky.edu   
Norton Cancer Institute - Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Renato LaRocca, MD    502-561-8200    rvl@kci.us   
Contact: Lisa Bailey    1 (502) 629-3449    lisa.bailey@nortonhealthcare.org   
United States, Louisiana
Louisiana State University Health Sciences Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Aaron Mammoser, MD    504-568-2698    amammo@lsuhsc.edu   
Contact: Erin Fannin    1 (504) 568-6127    efanni@lsuhsc.edu   
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders Recruiting
Scarborough, Maine, United States, 04074
Contact: Devon Evans, MD    207-396-7600    evansd@newecs.org   
Contact: Linda Reinholdtsen    207-396-7791    reinhl@newecs.org   
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Tracy Batchelor, MD    617-724-8770    tbatchelor@mgh.harvard.edu   
Contact: Edwin Nunez    1 (617) 643-4395    enunez2@mgh.harvard.edu   
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Eric Wong, MD    617-667-1665    ewong@bidmc.harvard.edu   
Contact: Zhenglin Guo    617-667-1832    zguo@bidmc.harvard.edu   
Dana Farber Cancer Institute, Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Wen, MD    617-632-2166    pwen@partners.org   
Contact: Gina Cach    (617) 632-6668    Gina_Cach@DFCI.HARVARD.EDU   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Tobias Walbert, MD    313-916-2723    smarl1@hfhs.org   
Contact: John Gaggin    313-916-3731    jgaggin1@hfhs.org   
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sani Kizilbash, MD    507-293-0494    kizilbash.sani@mayo.edu   
Contact: Cole McKean    507-293-3864    mckean.cole@mayo.edu   
United States, Missouri
HCA Midwest Division Recruiting
Kansas City, Missouri, United States, 64132
Contact: Amandeep Kalra, MD    816-698-7000    amandeep.kalra@hcahealthcare.com   
Contact: Pamela McCann    1 (816) 2763890    pamela.mccann@hcamidwest.com   
United States, New York
Dent Neurologic Institute Enrolling by invitation
Buffalo, New York, United States, 14226
Columbia University Medical Center, The Neurological Institute Recruiting
New York, New York, United States, 10032
Contact: Teri Kreisl, MD    212-342-0571    tnk2109@columbia.edu   
Contact: David Cieremans    (212) 342-4743    dc3195@cumc.columbia.edu   
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Simon Khagi, MD    919-966-4786    skhagi@med.unc.edu   
Contact: Lisa Brett    984-974-8253    lisa_brett@med.unc.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Annick Desjardins, MD    919-668-2993    desja002@mc.duke.edu   
Contact: Edy Parker    (919) 681-9932    edy.parker@duke.edu   
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Roy Strowd, MD    336-713-6979    rstrowd@wakehealth.edu   
Contact: Ashley Carroll    336-713-3539    arcarrol@wakehealth.edu   
United States, Ohio
The Cleveland Clinic, Richard E. Jacobs Health Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: David Peereboom, MD    216-445-6068    peerebd@ccf.org   
Contact: Kathy Smolenski    216-636-0793    SMOLENK2@ccf.org   
OhioHealth Research and Innovation Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Mohamed Hamza, MD    614-566-4200    mohamed.hamza@ohiohealth.com   
Contact: Meghan Lauf    (614) 566-1277    Meghan.Lauf@ohiohealth.com   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Dawit Aregawi, MD    717-531-3828    daregawi@hmc.psu.edu   
Contact: Scott Murphy    (717) 531-0003 ext 283114    smurphy6@pennstatehealth.psu.edu   
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Lyndon Kim, MD    215-955-7000    lyndon.kim@jefferson.edu   
Contact: Ginevra Park    (215) 955-5891    ginevra.park@jefferson.edu   
United States, South Carolina
Medical University of South Carolina, Hollings Cancer Center Recruiting
Charleston, South Carolina, United States, 29425
Contact: Scott Lindhorst, MD    843-792-2568    lindhors@musc.edu   
Contact: John Keller    843-792-2209    kellej@musc.edu   
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Paul Moots, MD       paul.moots@vanderbilt.edu   
Contact: VICC Clinical Trials Office    800-811-8480      
United States, Texas
Texas Oncology Austin Brain Tumor Center Recruiting
Austin, Texas, United States, 78705
Contact: Morris Groves, MD    512-421-4100    morris.groves@usoncology.com   
Contact: Kristen Brueggemann    1 (512) 427-9400    kristen.brueggemann@usoncology.com   
Neuro-Oncology Associates Recruiting
Dallas, Texas, United States, 75246
Contact: Karen Fink, MD    214-820-8690    karen.fink@bswhealth.org   
Contact: Lauren Zablosky    214-818-8196    Lauren.Zablosky@BSWHealth.org   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Marta Penas-Prado, MD    713-745-2164    mpenaspr@mdanderson.org   
Contact: Laci Clark    713-794-4476    csclark@mdanderson.org   
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Howard Colman, MD    801-581-7200    howard.colman@hci.utah.edu   
Contact: Brett Johnson    1 (801) 587-4429    brett.johnson@hci.utah.edu   
United States, Washington
Swedish Health Services Recruiting
Seattle, Washington, United States, 98122
Contact: Jerome Graber, MD    206-320-2300    jerome.graber@swedish.org   
Contact: Nathan Hansen    12063866073    Nathan.Hansen@swedish.org   
United States, Wisconsin
Waukesha Memorial Hospital Recruiting
Waukesha, Wisconsin, United States, 53188-5031
Contact: Hendrikus Krouwer, MD    262-928-2570    hendrikus.krouwer@phci.org   
Contact: Chanda Miller    1 (262) 928-5539    chanda.miller@phci.org   
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Pol Specenier, MD    +3238214014    pol.specenier@uza.be   
Contact: Myriam Mertens    +3238213814    myriam.mertens@uza.be   
Universitair Ziekenhuis Leuven Recruiting
Leuven, Flemish Brabant, Belgium, 3000
Contact: Paul Clement, MD    +3216346900    paul.clement@uzleuven.be   
Contact: Annelies Delorge    +3216343392    annelies.delorge@uzleuven.be   
Cliniques Universitaires UCL De Mont-Godinne Recruiting
Yvoir, Namur, Belgium, 5530
Contact: Lionel D'Hondt, MD    +3281423858    lionel.dhondt@uclouvain.be   
Contact: Frédéric Bellemans    +3281423855    frederic.bellemans@uclouvain.be   
Onze Lieve Vrouwziekenhuis Aalst Recruiting
Aalst, Oost-Vlaanderen, Belgium, 9300
Contact: Luc Verbeke, MD    +3253724479    luc.verbeke@olvz-aalst.be   
Contact: Ilse Claessens    +3253724502    ilse.claessens@olvz-aalst.be   
Canada, Alberta
Cross Cancer Institute Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Jacob Easaw, MD    780-432-8824    jay.easaw@albertahealthservices.ca   
Contact: Margo Miller    780-989-5969    margo.miller2@AHS.ca   
Tom Baker Cancer Center Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Gloria Urgoiti, MD    403-521-3912    gloria.roldanurgoiti@albertahealthservices.ca   
Contact: Mailin Deane    403-521-3888    mailin.deane@albertahealthservices.ca   
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Marshall Pitz, MD    204-787-8642    pitz@cc.umanitoba.ca   
Contact: Caitlin Kitkowski    204-787-4148    ckitkowski@cancercare.mb.ca   
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Garth Nicholas, MD    613-737-7700 ext. 70179    gnicholas@ottawahospital.on.ca   
Contact: Kaitlyn Chambers    613-737-7700 ext. 70955    kachambers@ohri.ca   
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: James Perry, MD    416-480-4766    james.perry@sunnybrook.ca   
Contact: Hyla Okorofsky    416-480-5000 ext. 7362    hyla.okorofsky@sunnybrook.ca   
Canada, Quebec
Montreal Neurological Institute and Hospital Recruiting
Montréal, Quebec, Canada, H3A 2B4
Contact: Kevin Petrecca, MD    514-398-2591    kevin.petrecca@mcgill.ca   
Contact: Lisa Nezvitsky    514-398-2801    lisa.nezvitsky@mcgill.ca   
Universtaetsklinikum Heidelberg - Neurologische Klinik Recruiting
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Contact: Antje Wick, MD    +4906221567075    antje.wick@med.uni-heidelberg.de   
Contact: Andrea Dormann    +4962215638265    andrea.dormann@med.uni-heidelberg.de   
Universtaetsklinikum Erlangen - Neurologische Klinik Recruiting
Erlangen, Bayern, Germany, 91054
Contact: Martin Uhl, MD    +4991318534640    martin.uhl@uk-erlangen.de   
Contact: Christa Gammel    +4991318534334    christa.menzel@uk-erlangen.de   
Klinik und Poliklinik fur Neurologie der Universitat Regensburg Recruiting
Regensburg, Bayern, Germany, 93053
Contact: Peter Hau, MD    +4909419418083    peter.hau@medbo.de   
Contact: Christine Kleinletzenberger    +499419418464    christine.kleinletzenberger@medbo.de   
Johnn-Wofgang-Goethe-Universitat Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60528
Contact: Oliver Baehr, MD    +49069630187711    oliver.baehr@med.uni-frankfurt.de   
Contact: Elvira Mueller    +4969630187711    elvira.mueller@kgu.de   
Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III Recruiting
Bonn, Nordrhein-Westfalen, Germany, 53105
Contact: Ulrich Herrlinger, MD    +4902282875736    ulrich.herrlinger@ukb.uni-bonn.de   
Contact: Barbara Scholl    +4922828719887    barbara.scholl@ukb.uni-bonn.de   
Heinrich-Heine-Universitat Duesseldorf Recruiting
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Contact: Michael Sabel, MD    +4902118117937    sabel@med.uni-duesseldorf.de   
Contact: Nicole Dietrichs    +4902118107471    nicole.dietrichs@med.uni-duesseldorf.de   
Universitätsklinikum Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Contact: Martin Glas, MD    +492017236513    mail@martinglas.de   
Contact: Ina Groen    +49201723650783707    ina.groen@uk-essen.de   
Universtatsklinikum Koln Klinik und Poliklinik fur Neurologie Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact: Pantelis Stavrinou, MD    +00492214784572    pantelis.stavrinou@uk-koeln.de   
Contact: Kay Hoelmer    +4902214786441    kay.hoelmer@uk-koeln.de   
Charite Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Martin Misch, MD    +4930450660097    martin.misch@charite.de   
Contact: Mandy Kilias    +4930450560255    mandy.kilias@charite.de   
Ruhr-Universitaet Bochum - Knappschaftskrankenhaus Bochum-Langendreer - Neurologische Recruiting
Bochum, Germany
Contact: Uwe Schlegel, MD    +492342993701    uwe.schlegel@kk-bochum.de   
Contact: Sylvia Rekowski    +4923429983703    sylvia.rekowski@kk-bochum.de   
Universitaetsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Manfred Westphal, MD    +49040741053750    westphal@uke.uni-hamburg.de   
Contact: Monique Beyer    +4940741053750    m.beyer@uke.de   
Universtaetsklinikum Giessen und Marburg GmbH - Marburg - Neurologische Klinik Recruiting
Marburg, Germany
Contact: Herwig Strik, MD    +4964215865179    strik@med.uni-marburg.de   
Contact: Gerda Engel    +4964215866892    engelg@med.uni-marburg.de   
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Oncohematology IRST Cesena Recruiting
Cesena, Italy
Contact: Toni Ibrahim, MD    +390543739100    toni.ibrahim@irst.emr.it   
Contact: Monia Dall'Agata    +390547352975    monia.dallagata@irst.emr.it   
Fondazione IRCCS - Instituto Neurologico Carlo Besta Recruiting
Milano, Italy, 20133
Contact: Gaetano Finocchiaro, MD    39 02-2394-2454    gaetano.finocchiaro@istituto-besta.it   
Contact: Paola Porrati    +390223942769    paola.porrati@gmail.com   
Istituto Oncologico Veneto Recruiting
Padova, Italy
Contact: Giuseppe Lombardi, MD    +390498215910    giuseppe.lombardi@ioveneto.it   
Contact: Miriam Farina    +390498215908    miriam.farina@ioveneto.it   
Istituto Nazionale dei Tumori Regina Elena - IRE Recruiting
Roma, Italy, 00144
Contact: Carmine Carapella, MD    +0652665595    carapella@ifo.it   
Contact: Veronica Villani, MD    +390652666068    veronica.villani@ifo.gov.it   
Azienda Ospedaliera Universitaria Senese - Policlinico S. Maria alle Scotte Recruiting
Siena, Italy, 53100
Contact: Michele Maio, MD    +390577586335    mmaiocro@gmail.com   
Contact: Giovanni Amato    +390577586326    dataman.immonco@ao-siena.toscana.it   
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette Recruiting
Torino, Italy, 10126
Contact: Riccardo Soffietti, MD    +390116334904    riccardo.soffietti@unito.it   
Contact: Cinzia Bertolotti    +390116334904    neuro.oncologia.cbertolotti@gmail.com   
Sint Elisabeth Ziekenhuis Recruiting
Tilburg, Noord-Brabant, Netherlands, 5022 GC
Contact: Laurens Beerepoot, MD    +31135393069    l.beerepoot@etz.nl   
Contact: Chantal Knapen    +31657341761    c.knapen@etz.nl   
Vrije Universiteit Medisch Centrum (VUMC) Recruiting
Amsterdam, Noord-Holland, Netherlands, 1081 HV
Contact: Myra Van Linde, MD    +31204444321    m.vanlinde@vumc.nl   
Contact: Laura Pijpers    +310204444773    l.pijpers@vumc.nl   
Erasmus Medisch Centrum Daniel den Hoed Recruiting
Rotterdam, Zuid-Holland, Netherlands, 3075 EA
Contact: Martin Van den Bent, MD    +31107041415    m.vandenbent@erasmusmc.nl   
Contact: Irene van Heuvel    +31107041744    i.vanheuvel@erasmusmc.nl   
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Filip De Vos, MD    +31243610353    f.devos@umcutrecht.nl   
Contact: Anette Van Dijk    +31 88 75 562 63    a.j.g.vandijk@umcutrecht.nl   
Sponsors and Collaborators
Orbus Therapeutics, Inc.
Study Director: Marietta Franco, MS Orbus Therapeutics, Inc.

Responsible Party: Orbus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02796261     History of Changes
Other Study ID Numbers: OT-15-001
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Orbus Therapeutics, Inc.:
Anaplastic Astrocytoma
Grade 3 Glioma
Brain Cancer
Brain Tumor
Progressive Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
Progressive Glioma
Recurrent Glioma
Malignant Glioma
Progressive Brain Tumor
Recurrent Brain Tumor

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Ornithine Decarboxylase Inhibitors
Enzyme Inhibitors