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Spots Global Cancer Trial Database for Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

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Trial Identification

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

Interventions

Belinostat

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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