Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TopoTarget A/S
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00865969
First received: March 19, 2009
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.


Condition Intervention Phase
Peripheral T-cell Lymphoma
Drug: PXD101
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Primary - Objective response rate [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, further efficacy parameters (e.g. time to response, duration of response, time to progression, and survival), and population pharmacokinetics [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Belinostat
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion
Drug: PXD101
Belinostat (PXD101) 1000 mg/m²administered as a 30 minute IV infusion on days 1-5 of every 3-week cycle
Other Name: Belinostat

Detailed Description:

This is an open-label, multicenter, single arm efficacy and safety study in patients with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy.

Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m² 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 IHP revision 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 NCI-CTCAE v. 3.0.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • A histologically confirmed diagnosis of PTCL
  • Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
  • Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).
  • Age ≥ 18 years.
  • Adequate bone marrow, liver, and renal functions.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Negative pregnancy test for women of childbearing potential.

Exclusion criteria:

  • Relapse within 100 days of autologous or allogeneic bone marrow transplant.
  • Prior HDAC inhibitor therapy.
  • Co-existing active infection or any medical condition likely to interfere with trial procedures.
  • Severe cardiovascular disease.
  • Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
  • Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
  • Symptomatic or untreated central nervous system (CNS) metastases.
  • Pregnant or breast-feeding women.
  • Known infection with HIV, hepatitis B or hepatitis C.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865969

  Hide Study Locations
Locations
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Wilshire Oncology Medical Group, Inc
La Verne, California, United States, 91750
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Connecticut
Yale Cancer Center-Section of Medical Oncology
New Haven, Connecticut, United States, 06520
Oncology Associates of Bridgeport
Trumbull, Connecticut, United States, 06611
United States, Florida
Boca Raton Clinical Research Associates
Boca Raton, Florida, United States, 33432
United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912-3125
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
Kellogg Cancer Care Center
Evanston, Illinois, United States, 60201
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615
United States, Maryland
Center for Cancers and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Saint Louis University
St. Louis, Missouri, United States, 63110
United States, New Jersey
Northern New Jersey Cancer Associates
Hackensack, New Jersey, United States, 07601
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Bronx River Medical Associates, PC
Bronx, New York, United States, 10467
Erie County Medical Center (Roswell Park)
Buffalo, New York, United States, 14215
Monter Cancer Center
Lake Success, New York, United States, 11067
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York University Cancer Institute
New York, New York, United States, 10016
New York University
New York City, New York, United States, 10016
Upstate Medical Univeristy Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Hematology Associates
Bedford, Ohio, United States, 44146
United States, Pennsylvania
St Luke's Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Dakota
Avera Cancer Center
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Associates In Oncology and Hematology
Chattanooga, Tennessee, United States, 37421
University of Tennessee Cancer Institute
Knoxville, Tennessee, United States, 37920
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Memphis, Tennessee, United States, 38138
United States, Texas
UT - M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
The UT Health Science Centre at San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0035
United States, Washington
Cascade Cancer Center
Kirkland, Washington, United States, 98304
Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Belgium
ZNA Stuivenberg
Antwerpen, Belgium, 2060
ZNA Middelheim
Antwerpen, Belgium, 2020
Clinique Universitaire Saint Luc, Service Hématologie
Bruxelles, Belgium, 1200
AZ St. Jan
Brügge, Belgium, 8000
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
University of Liege, Divisions of Hematology and Medical Oncology
Liege, Belgium, 4000
Cliniques Universitaires UCL Mont Godinne, Service Hématologie
Yvoir, Belgium, 5530
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Quebec
CHA Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada, G1J1Z4
Canada
McGill University
Montreal, Canada, H2W1S6
Croatia
CHC Split Clinic of Internal Diseases
Split, Croatia, 21000
UH Dubrava Clinic of Internal Diseases
Zagreb, Croatia, 10000
CHC Zagreb Clinic of Internal Diseases
Zagreb, Croatia, 10000
CHC Rijeka, Clinic of Internal Diseases
Zagreb, Croatia, 1000
Denmark
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
Copenhagen, Denmark, 2100
France
Hôpital de l'Archet, Centre Hospitalier Universitaire (CHU) de Nice, Hématologie Clinique
Nice, France, 6202
Groupe Hospitalier Sud Réunion, Site Saint-Pierre
Saint-Pierre Cedex, France, 97448
Germany
Klinik Essen Süd, Evangelisches Krankenhaus
Essen, Germany, 45239
Leitender Oberarzt/Klinik für Onkologie und Hämatologie
Frankfurt, Germany, 60488
Universität Göttingen, Abteilung Hämatologie und Onkologie
Göttingen, Germany, 37075
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06120
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66424
Universitätsklinikum Leipzig AöR
Leipzig, Germany, 04103
Universitätsmedizin der johannes Gutenberg -Universität Mainz
Mainz, Germany, 55131
University Hospital Marburg
Marburg, Germany, 35043
Münchner Studienzentrum Klinikum Rechts der Isar
München, Germany, 81675
Klinikum Nuernberg Nord
Nuernberg, Germany, 90419
Universitätsklinikum Rostock
Rostock, Germany, 18057
Universitätsklinikum Ulm
Ulm, Germany, 89081
Hungary
Szt István és Szt. Laszlo
Budapest, Hungary, 1097
Belgyógyászati Klinika
Debrecen, Hungary, 4032
Belgyógyászati Klinika Györ
Györ, Hungary, 9042
Belgyógyászati Klinika es Kardiologial Központ
Szeged, Hungary, 6720
Israel
The Soroka University Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Center Department of Hematology
Haifa, Israel, 31096
Hadassah University Hospital Sharet Building Department of Hematology
Jerusalem, Israel, 91120
Rabin Medical Center Belinson Campus
Petach Tikva, Israel, 49100
Italy
Ospedale Sant'Orsola, Instituto di Ematologia e Oncologia Medica
Bologna, Italy, 40138
Ospedale Policlinico Careggi
Firenze, Italy, 50134
Netherlands
VU Medical Center, Department of Haematology
Amsterdam, Netherlands, 7081 HV
University Medical Center Groningen UMCG, Department of Haematologie
Groningen, Netherlands, 9700
Erasmus University Medical Center
Rotterdam, Netherlands, 3015
Isala Clinics, Department of Haematololgy
Zwolle, Netherlands, 8025 AB
Poland
Klinika Nowotworów Ukladu Chlonnego Centrum Onkologii Instytut Marii Sklodowskiej-Curie
Warszawa, Mazowieckie, Poland, 02-781
Uniwersyteckie Centrum Kliniczne Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Małopolskie Centrum Medyczne
Kraków, Poland, 30-510
Szpital Wojewódzki w Opolu/Oddział Hematologii
Opole, Poland, 45-051
Instytut Hematologii i Transfuzjologii Klinika Hematologii
Warszawa, Poland, 02-776
MTZ Clinical Research Sp z o.o.
Warszawa, Poland, 02-106
Wojskowy Instytut Medyczny Klinika Chorób/Wewnętrznych i Hematologii Centralnego Szpitala
Warszawa, Poland, 04-141
Wojewódzki Szpital Specjalistyczny im M. Kopernika w Łodzi Oddział Hematologii - Klinika Hematologii
Łódź, Poland, 93-510
Russian Federation
State Therapeutical and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk, Russian Federation, 454087
Russian Cancer Research Centre named after N.N. Blokhin of Russian Academy of Medical Sciences
Moscow, Russian Federation, 115478
Research Center of Haematology
Moscow, Russian Federation, 125167
Slovakia
Narodny Onkologicky Ustav (NOU)
Bratislava, Slovakia, 83310
Klinika Hematologie a Onkohematologie FNLP a LF UPJS
Kosice, Slovakia, 04066
South Africa
Tygerberg Hospital, Department of Radiation Oncology
Bellville, South Africa, 7505
Drs pirjol, Szpak and Moodley Inc.
Durban, South Africa, 4126
Pretoria Academic Hospital, Department of Radiation Oncology
Pretoria, South Africa, 0002
Medical Oncology 2nd Floor Radiotherapy building Steve Biko Academic Hospital
Pretoria, South Africa, 0002
Spain
Complexo Hospitalario a Coruna
A Coruna, Spain, 15006
ICO Hospital Germans Trias i Pujol
Badalona, Spain, 08918
Hospital Duran i Reinals
Barcelona, Spain, 08007
Hospital Universitario Virgen de la Arrixaca
El Palmar, Spain, 30120
Hospital General Universitario Gregorio Maranón
Madrid, Spain, CP 28007
Hospital Universitario Morales Meseguer
Murcia, Spain, 30008
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital Clinico Universitario de Santiago
Santiago De Compostella, La Coruna, Spain, 15706
United Kingdom
St James's Institute of Oncology Bexley Wing
Leeds, United Kingdom, LS9 7TF
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Institute of Cancer/ Centre for Medical Oncology/Barts and The London School of Medicine and Dentistry
London, United Kingdom, EC1A 7BE
The Christie NHS Foundation Trust, The Christie Hospital,
Manchester, United Kingdom, M20 4BX
Northern Centre for Cancer Care, Freeman Hospital
Newcastle Upon Tyne, United Kingdom, NE7 7DN
The Royal Marsden Haemato-Oncology Wards
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
TopoTarget A/S
Investigators
Principal Investigator: Peter Brown, MD H:S Rigshospitalet, Department of Hematology, Denmark
Principal Investigator: Pier L Zinzani, MD Università di Bologna, Italy
Principal Investigator: André Bosly, MD Cliniques Universitaires UCL Mont Godinne, Belgium
Principal Investigator: Georges Fillet, MD University of Liege, Belgium
Principal Investigator: Eric van den Neste, MD Clinique Universitaier Saint Luc, Belgium
Principal Investigator: Nicolas Monier, MD Hôpital de l'Archet 1 Centre Hospitalier Universitaire (CHU) de Nice, France
Principal Investigator: Elisabeth Perez, MD Groupe Hospitalier Sud Réunion, France
Principal Investigator: Maria Delioukina, MD City of Hope National Medical Center, USA
Principal Investigator: Adam Lerner, MD Boston Medical Center, USA
Principal Investigator: Lydia Dreosti, MD Pretoria Academic Hospital, South Africa
Principal Investigator: D. Moodley, MD Drs Pirjol, Szpak and Moodley Inc, Durban, South Africa
Principal Investigator: Hanneke C. Kluin-Nelemans, MD University Medical Center Groningen UMCG, The Netherlands
Principal Investigator: G. Sissolak, MD Tygerberg Hospital, Cape Town, South Africa
Principal Investigator: L. Verdonk, MD Isala Clinics, Zwolle, The Netherlands
Principal Investigator: O. Visser, MD VU Medical Center, Amsterdam, The Netherlands
Principal Investigator: Owen A. O'Connor, MD New York University Cancer Institute, USA
Principal Investigator: Sarit Assouline, MD McGill University, Department of Oncology Clinical Research Program, Montreal, Canada
Principal Investigator: Juan Manuel Sancho Cia, MD ICO Hospital Germans Trias i Pujol, Badalona, Spain
Principal Investigator: Consolación Rayon, MD Hospital Universitario Central de Asturias, Oviedo, Spain
Principal Investigator: Sonia Gonzales, MD Hospital Clinico Universitario de Santiago, Santiago de Compostella, Spain
Principal Investigator: Lorenz Trümper, MD Universität Göttingen, Abteilung Hämatologie und Onkologie, Göttingen, Germany
Principal Investigator: Andreas Viardot, MD Universitätsklinikum Ulm, Ulm, Germany
Principal Investigator: Georg Hess, MD Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, Germany
Principal Investigator: Hans-Heinrich Wolf, MD Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg, Halle, Germany
Principal Investigator: Andreas Neubauer, MD University Hospital Marburg, Marburg, Germany
Principal Investigator: Michele Frank, MD Cascade Cancer Center
Principal Investigator: Madeleine Duvic, MD UT - M. D. Anderson Cancer Center
Principal Investigator: Andrei Shustov, MD Fred Hutchinson Cancer Research Center - Seattle Cancer Care Alliance
Principal Investigator: Melissa Runge-Morris, MD Karmanos Cancer Institute
Principal Investigator: Nalini Janakiraman, MD Henry Ford Health System
Principal Investigator: Amanda Cashen, MD Wasington University School of Medicine- Division of Oncology
Principal Investigator: Beata Holkova, MD Massey Cancer Center
Principal Investigator: Mohammad Tirgan, MD Hematology Associates
Principal Investigator: Bernard Poiesz, MD Upstate Medical Univeristy Syracuse
Principal Investigator: Charles Farber, MD Morristown Memorial Hospital
Principal Investigator: Zale Bernstein, MD Erie County Medical Center (Roswell Park)
Principal Investigator: Ralph Boccia, MD Center for Cancers and Blood Disorders
Principal Investigator: David Grinblatt, MD Kellogg Cancer Care Center
Principal Investigator: Laura Blakely, MD Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)
Principal Investigator: David Dennis, MD Boca Raton Clinical Research Associates
Principal Investigator: Fernando Camacho, MD Bronx River Medical Associates, PC
Principal Investigator: Eliot Epner, MD Penn State Hershey Cancer Institute
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00865969     History of Changes
Other Study ID Numbers: PXD101-CLN-19, 2008-005843-40
Study First Received: March 19, 2009
Last Updated: February 11, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Croatia: Agency for Medicinal Product and Medical Devices
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Spectrum Pharmaceuticals, Inc:
Belinostat
peripheral T-cell lymphoma
PXD101
PTCL
HDAC inhibitor
histone deacetylase inhibitor

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma
Lymphoma, T-Cell, Peripheral
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Belinostat
Histone Deacetylase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014