Spots Global Cancer Trial Database for Forodesine in the Treatment of Cutaneous T-Cell Lymphoma
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Trial Identification
Brief Title: Forodesine in the Treatment of Cutaneous T-Cell Lymphoma
Official Title: Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
Study ID: NCT00501735
Conditions
Interventions
Study Description
Brief Summary: This is a Phase II, non-randomized, open-label, single-arm trial that will be conducted at up to 50 sites in North America, Europe and Australia. This study is designed to assess objective response (OR) \[complete response (CR) or partial response (PR)\] in subjects with cutaneous manifestations of CTCL with a requirement for maintenance of such objective response for at least 28 days in subjects with stage IIB, III, and IVA CTCL. Additionally, this study will evaluate the safety and tolerability of CTCL subjects Stages IB, IIA, IIB, III, or IVA treated with oral forodesine.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Comprehensive Cancer Ctr, Birmingham, Alabama, United States
Stanford University Medical Center, Stanford, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States
Boston Medical Center, Boston, Massachusetts, United States
Washington University School of Medicine, St. Louis, Missouri, United States
Hackensack University Medical Ctr, Hackensack, New Jersey, United States
Upstate Medical University, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Health Sceinces, Dept. of Dermatology, Winston-Salem, North Carolina, United States
Gabrail Cancer Center, Canton, Ohio, United States
University Hospitals Case Medical Center, Dept. of Dermatology, Cleveland, Ohio, United States
Hospital at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Hillman Cancer Ctr., University of Pittsburgh, Pittsburgh, Pennsylvania, United States
M.D. Anderson Cancer Center - Dermatology, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin-Madison, Dept of Dermatology, Madison, Wisconsin, United States
Cabrini Hospital, Malvern, Victoria, Australia
Wien, Wien, , Austria
Helsinki, Helsinki, , Finland
Hopital Hotel-Dieu, Clermont-Ferrand, , France
Creteil, Creteil, , France
Montpellier, Montpellier, , France
Pessac, Pessac, , France
CHU Robert Debre, Reims CEDEX, , France
Toulouse, Toulouse, , France
Campus Charité Mitte, Berlin, , Germany
Universitatsklinikum Jena, Jena, , Germany
Universitat Kiel, Kiel, , Germany
Klinik fur Dermatologie, Venerologie und Allergologie, Mannheim, , Germany
Bologna, Bologna, , Italy
Firenze, Firenze, , Italy
Milan, Milan, , Italy
Rome, Rome, , Italy
Torino, Torino, , Italy
Madrid, Madrid, , Spain
Zurich, Zurich, , Switzerland
London, London, , United Kingdom
Manchester, Manchester, , United Kingdom
Contact Details
Name: Nashat Gabrail, MD
Affiliation: Gabrail Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Madeleine Duvic, MD
Affiliation: M.D. Anderson Cancer Center - Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Youn Kim, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
Name: Andres Forero-Torres, M.D.
Affiliation: University of Alabama at Birmingham, Comprehensive Cancer Ctr.
Role: PRINCIPAL_INVESTIGATOR
Name: Alan B Fleischer, Jr., MD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Gary S. Wood, MD
Affiliation: University of Wisconsin-Madison, Dept of Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Andre Goy, MD
Affiliation: Hackensack Universeity Medical Ctr
Role: PRINCIPAL_INVESTIGATOR
Name: Larisa Geskin, MD
Affiliation: Hillman Cancer Ctr., University of Pittsburgh
Role: PRINCIPAL_INVESTIGATOR
Name: Nancy Bartlett, MD
Affiliation: Washington University School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Francine Foss, MD
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
Name: Miles Prince, MD
Affiliation: Cabrini Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Elise Olsen, MD
Affiliation: Duke University
Role: PRINCIPAL_INVESTIGATOR
Name: Sareeta S Parker, MD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR
Name: Neil J Korman, MD, PhD
Affiliation: University Hospitals Case Medical Ctr., Dept. of Dermatology
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Turturro, MD
Affiliation: LSU Health Sciences Ctr., Feist-Weiller Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Andrei R Shustov, MD
Affiliation: Seattle Cancer Care Alliance
Role: PRINCIPAL_INVESTIGATOR
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