Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma - Full Text View

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:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

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:	September 2013
Primary Completion Date:	December 2011 (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

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

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Locations

United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, Connecticut
Yale Cancer Center-Section of Medical Oncology
New Haven, Connecticut, United States, 06520
United States, Florida
Boca Raton Clinical Research Associates
Boca Raton, Florida, United States, 33432
United States, Illinois
Kellogg Cancer Care Center
Evanston, Illinois, United States, 60201
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
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
United States, New Jersey
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
New York University Cancer Institute
New York, New York, United States, 10016
Upstate Medical Univeristy Syracuse
Syracuse, New York, United States, 13210
United States, Ohio
Hematology Associates
Bedford, Ohio, United States, 44146
United States, Tennessee
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
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
McGill University
Montreal, Canada, H2W1S6
Croatia
CHC Split Clinic of Internal Diseases
Split, Croatia, 21000
CHC Rijeka, Clinic of Internal Diseases
Zagreb, Croatia, 1000
CHC Zagreb Clinic of Internal Diseases
Zagreb, Croatia, 10000
UH Dubrava Clinic of Internal Diseases
Zagreb, Croatia, 10000
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
Universität Göttingen, Abteilung Hämatologie und Onkologie
Göttingen, Germany, 37075
Universitätsklinikum (AöR) der Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06120
Universitätsmedizin der johannes Gutenberg -Universität Mainz
Mainz, Germany, 55131
University Hospital Marburg
Marburg, Germany, 35043
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
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
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
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

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:	May 8, 2013
Health Authority:	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
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013

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