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Brief Title: Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Official Title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
Study ID: NCT00865969
Brief Summary: The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
Detailed Description: This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. Approximately 120 participants will be enrolled. Participants will be treated with 1000 mg/m\^2 belinostat administered as a 30-minute IV infusion on Days 1-5 of every 3-week cycle until there is disease progression or unmanageable treatment-related toxicities. The primary study endpoint is objective response rate (ORR) based on the International Harmonization Project (IHP) revision International Working Group (IWG) criteria. Safety will be evaluated during the study and for 30 days after the last administration of study drug. Adverse events and laboratory studies will be graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 3.0.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
Wilshire Oncology Medical Group, Inc, La Verne, California, United States
Comprehensive Cancer Center, Palm Springs, California, United States
Yale Cancer Center-Section of Medical Oncology, New Haven, Connecticut, United States
Oncology Associates of Bridgeport, Trumbull, Connecticut, United States
Boca Raton Clinical Research Associates, Boca Raton, Florida, United States
Georgia Health Sciences University, Augusta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Kellogg Cancer Care Center, Evanston, Illinois, United States
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland, Niles, Illinois, United States
Illinois CancerCare, P.C., Peoria, Illinois, United States
Center for Cancers and Blood Disorders, Bethesda, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Boston University Medical Center, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Saint Louis University, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Northern New Jersey Cancer Associates, Hackensack, New Jersey, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Bronx River Medical Associates, PC, Bronx, New York, United States
Erie County Medical Center (Roswell Park), Buffalo, New York, United States
Monter Cancer Center, Lake Success, New York, United States
New York University Cancer Institute, New York, New York, United States
New York University, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Upstate Medical Univeristy Syracuse, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Hematology Associates, Bedford, Ohio, United States
St Luke's Cancer Center, Bethlehem, Pennsylvania, United States
Penn State Hershey Cancer Institute, Hershey, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Avera Cancer Center, Sioux Falls, South Dakota, United States
Associates In Oncology and Hematology, Chattanooga, Tennessee, United States
University of Tennessee Cancer Institute, Knoxville, Tennessee, United States
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN), Memphis, Tennessee, United States
UT - M. D. Anderson Cancer Center, Houston, Texas, United States
The UT Health Science Centre at San Antonio, San Antonio, Texas, United States
Massey Cancer Center, Richmond, Virginia, United States
Cascade Cancer Center, Kirkland, Washington, United States
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance, Seattle, Washington, United States
ZNA Middelheim, Antwerpen, , Belgium
ZNA Stuivenberg, Antwerpen, , Belgium
Clinique Universitaire Saint Luc, Service Hématologie, Bruxelles, , Belgium
AZ St. Jan, Brügge, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
University of Liege, Divisions of Hematology and Medical Oncology, Liege, , Belgium
Cliniques Universitaires UCL Mont Godinne, Service Hématologie, Yvoir, , Belgium
University of British Columbia, Vancouver, British Columbia, Canada
CHA Hôpital de l'Enfant-Jésus, Quebec City, Quebec, Canada
McGill University, Montreal, , Canada
CHC Split Clinic of Internal Diseases, Split, , Croatia
CHC Zagreb Clinic of Internal Diseases, Zagreb, , Croatia
UH Dubrava Clinic of Internal Diseases, Zagreb, , Croatia
CHC Rijeka, Clinic of Internal Diseases, Zagreb, , Croatia
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241, Copenhagen, , Denmark
Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique, Nice, , France
Groupe Hospitalier Sud Réunion, Site Saint-Pierre, Saint-Pierre Cedex, , France
Klinik Essen Süd, Evangelisches Krankenhaus, Essen, , Germany
Leitender Oberarzt/Klinik für Onkologie und Hämatologie, Frankfurt, , Germany
Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, , Germany
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, , Germany
Asklepios Klinik St. Georg, Hamburg, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Universitätsklinikum Leipzig AöR, Leipzig, , Germany
Universitätsmedizin der johannes Gutenberg -Universität Mainz, Mainz, , Germany
University Hospital Marburg, Marburg, , Germany
Münchner Studienzentrum Klinikum Rechts der Isar, München, , Germany
Klinikum Nuernberg Nord, Nuernberg, , Germany
Universitätsklinikum Rostock, Rostock, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Szt István és Szt. Laszlo, Budapest, , Hungary
Belgyógyászati Klinika, Debrecen, , Hungary
Belgyógyászati Klinika Györ, Györ, , Hungary
Belgyógyászati Klinika es Kardiologial Központ, Szeged, , Hungary
The Soroka University Medical Center, Beer Sheva, , Israel
Rambam Medical Center Department of Hematology, Haifa, , Israel
Hadassah University Hospital Sharet Building Department of Hematology, Jerusalem, , Israel
Rabin Medical Center Belinson Campus, Petach Tikva, , Israel
Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica, Bologna, , Italy
Ospedale Policlinico Careggi, Firenze, , Italy
VU Medical Center, Department of Haematology, Amsterdam, , Netherlands
University Medical Center Groningen UMCG, Department of Haematologie, Groningen, , Netherlands
Erasmus University Medical Center, Rotterdam, , Netherlands
Isala Clinics, Department of Haematololgy, Zwolle, , Netherlands
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii, Gdansk, , Poland
Małopolskie Centrum Medyczne, Kraków, , Poland
Szpital Wojewódzki w Opolu/Oddział Hematologii, Opole, , Poland
MTZ Clinical Research Sp z o.o., Warszawa, , Poland
Instytut Hematologii i Transfuzjologii Klinika Hematologii, Warszawa, , Poland
Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala, Warszawa, , Poland
Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii, Łódź, , Poland
State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, , Russian Federation
Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences, Moscow, , Russian Federation
Research Center of Haematology, Moscow, , Russian Federation
Narodny Onkologicky Ustav (NOU), Bratislava, , Slovakia
Klinika Hematologie a Onkohematologie FNLP a LF UPJS, Kosice, , Slovakia
Tygerberg Hospital, Department of Radiation Oncology, Bellville, , South Africa
Drs pirjol, Szpak and Moodley Inc., Durban, , South Africa
Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital, Pretoria, , South Africa
Pretoria Academic Hospital, Department of Radiation Oncology, Pretoria, , South Africa
Complexo Hospitalario a Coruna, A Coruna, , Spain
Hospital Clinico Universitario de Santiago, A Coruña, , Spain
ICO Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Duran i Reinals, Barcelona, , Spain
Hospital Universitario Virgen de la Arrixaca, El Palmar, , Spain
Hospital General Universitario Gregorio Maranón, Madrid, , Spain
Hospital Universitario Morales Meseguer, Murcia, , Spain
Hospital Universitario Central de Asturias, Oviedo, , Spain
St James's Institute of Oncology Bexley Wing, Leeds, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry, London, , United Kingdom
The Christie NHS Foundation Trust, The Christie Hospital,, Manchester, , United Kingdom
Northern Centre for Cancer Care, Freeman Hospital, Newcastle Upon Tyne, , United Kingdom
The Royal Marsden Haemato-Oncology Wards, Sutton, , United Kingdom
Name: Peter Brown, MD
Affiliation: H:S Rigshospitalet, Department of Hematology, Denmark
Role: PRINCIPAL_INVESTIGATOR
Name: Pier L Zinzani, MD
Affiliation: Università di Bologna, Italy
Role: PRINCIPAL_INVESTIGATOR
Name: André Bosly, MD
Affiliation: Cliniques Universitaires UCL Mont Godinne, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: Georges Fillet, MD
Affiliation: University of Liege, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: Eric van den Neste, MD
Affiliation: Clinique Universitaier Saint Luc, Belgium
Role: PRINCIPAL_INVESTIGATOR
Name: Nicolas Monier, MD
Affiliation: Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Role: PRINCIPAL_INVESTIGATOR
Name: Elisabeth Perez, MD
Affiliation: Groupe Hospitalier Sud Réunion, France
Role: PRINCIPAL_INVESTIGATOR
Name: Maria Delioukina, MD
Affiliation: City of Hope National Medical Center, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Adam Lerner, MD
Affiliation: Boston Medical Center, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Lydia Dreosti, MD
Affiliation: Pretoria Academic Hospital, South Africa
Role: PRINCIPAL_INVESTIGATOR
Name: D. Moodley, MD
Affiliation: Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Role: PRINCIPAL_INVESTIGATOR
Name: Hanneke C. Kluin-Nelemans, MD
Affiliation: University Medical Center Groningen UMCG, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: G. Sissolak, MD
Affiliation: Tygerberg Hospital, Cape Town, South Africa
Role: PRINCIPAL_INVESTIGATOR
Name: L. Verdonk, MD
Affiliation: Isala Clinics, Zwolle, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: O. Visser, MD
Affiliation: VU Medical Center, Amsterdam, The Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Owen A. O'Connor, MD
Affiliation: New York University Cancer Institute, USA
Role: PRINCIPAL_INVESTIGATOR
Name: Sarit Assouline, MD
Affiliation: McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Juan Manuel Sancho Cia, MD
Affiliation: ICO Hospital Germans Trias i Pujol, Badalona, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Consolación Rayon, MD
Affiliation: Hospital Universitario Central de Asturias, Oviedo, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Sonia Gonzales, MD
Affiliation: Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Lorenz Trümper, MD
Affiliation: Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Andreas Viardot, MD
Affiliation: Universitätsklinikum Ulm, Ulm, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Georg Hess, MD
Affiliation: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Hans-Heinrich Wolf, MD
Affiliation: Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Andreas Neubauer, MD
Affiliation: University Hospital Marburg, Marburg, Germany
Role: PRINCIPAL_INVESTIGATOR
Name: Michele Frank, MD
Affiliation: Cascade Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Madeleine Duvic, MD
Affiliation: UT - M. D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei Shustov, MD
Affiliation: Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR
Name: Melissa Runge-Morris, MD
Affiliation: Barbara Ann Karmanos Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Nalini Janakiraman, MD
Affiliation: Henry Ford Health System
Role: PRINCIPAL_INVESTIGATOR
Name: Amanda Cashen, MD
Affiliation: Wasington University School of Medicine- Division of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Beata Holkova, MD
Affiliation: Massey Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Mohammad Tirgan, MD
Affiliation: Hematology Associates
Role: PRINCIPAL_INVESTIGATOR
Name: Bernard Poiesz, MD
Affiliation: Upstate Medical Univeristy Syracuse
Role: PRINCIPAL_INVESTIGATOR
Name: Charles Farber, MD
Affiliation: Morristown Memorial Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Zale Bernstein, MD
Affiliation: Erie County Medical Center (Roswell Park)
Role: PRINCIPAL_INVESTIGATOR
Name: Ralph Boccia, MD
Affiliation: Center for Cancers and Blood Disorders
Role: PRINCIPAL_INVESTIGATOR
Name: David Grinblatt, MD
Affiliation: Kellogg Cancer Care Center
Role: PRINCIPAL_INVESTIGATOR
Name: Laura Blakely, MD
Affiliation: Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Role: PRINCIPAL_INVESTIGATOR
Name: David Dennis, MD
Affiliation: Boca Raton Clinical Research Associates
Role: PRINCIPAL_INVESTIGATOR
Name: Fernando Camacho, MD
Affiliation: Bronx River Medical Associates, PC
Role: PRINCIPAL_INVESTIGATOR
Name: Eliot Epner, MD
Affiliation: Penn State Hershey Cancer Institute
Role: PRINCIPAL_INVESTIGATOR