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Brief Title: Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Official Title: A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)
Study ID: NCT00518895
Brief Summary: This study is being performed to prospectively determine whether dacarbazine plus Genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus Genasense.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of South Alabama Hospital, Mitchell Cancer Institute, Mobile, Alabama, United States
San Diego Pacific Oncology and Hematology Associates Inc., Encinitas, California, United States
Redwood Regional Medical Group, Inc., Santa Rosa, California, United States
Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hematology Oncology Centers of the Northern Rockies, Billings, Montana, United States
Morristown Memorial - Atlantic Healthcare System, Morristown, New Jersey, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Site 1, Tulsa, Oklahoma, United States
St. Luke's Cancer Center, Bethlehem, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
The West Clinic, Memphis, Tennessee, United States
Texas Oncology - Sammons Cancer Center, Dallas, Texas, United States
MD Anderson Cancer Center at University of Texas, Houston, Texas, United States
Sydney Cancer Center, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
Calvary Mater Newcastle, Newcastle, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck, Innsbruck, , Austria
Landesklinikum St. Polten, St. Polten, , Austria
Medical University of Vienna, Vienna General Hospital, Wien, , Austria
London Regional Cancer Program, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Charles University, Dermatology Department, Prague, , Czech Republic
CHU Saint Jacques, Besancon, , France
Hopital Saint-Andre, Bordeaux, , France
CHU Ambroise Pare, Boulogne-Billancourt, , France
CHU Hotel Dieu, Clermont Ferrand, , France
CHU de Dijon, Hopital du Bocage Sud, Dijon, , France
CHU de Grenoble, Hopital Albert Michallon, Grenoble, , France
Centre Hospitalier du Mans, Le Mans, , France
CHRU de Lille, Hopital Claude Huriez, Lille, , France
Hopital de l'Hotel Dieu, Lyon, , France
Hopital Sainte Marguerite, Marseille, , France
Hopital Saint Eloi, Montpellier, , France
CHU Hotel Dieu, Nantes, , France
Hopital Saint-Louis, Paris, , France
Hopital Robert Debre, Reims, , France
CHU CH Nicolle, Rouen, , France
Institut Gustave Roussy, Villejuif, , France
Charite Universitatsmedizin Berlin, Berlin, , Germany
Vivantes Klinikum im Friedrichshain, Berlin, , Germany
Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie, Berlin, , Germany
Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum, Bochum, , Germany
Helios Klinikum Erfurt, Erfurt, , Germany
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen, Essen, , Germany
Universitatsklinikum Freiburg, Freiburg, , Germany
Hautklinik Linden, Hannover, , Germany
Klinikum der Friedrich-Schiller-Universitat Jena, Jena, , Germany
Klinik und Poliklinik fur Dermatologie und Venerologie, Koln, , Germany
Universitatklinikum A. o. R., Leipzig, , Germany
Hospital of the University of Schleswig-Holstein, Lubeck, , Germany
Universitats-Hautklinik Mainz, Mainz, , Germany
Universitatsklinikum Mannheim, Mannheim, , Germany
Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie, Marburg, , Germany
Klinik und Poliklinik fur Hautkrankheiten, Munster, , Germany
Helios Vogtland-Klinikum Plauen, Plauen, , Germany
Klinikum Quedlinburg, Quedlinburg, , Germany
Dermatologische Klinik und Poliklinik, Regensburg, , Germany
Hautklinik Universitat Tubingen, Tubingen, , Germany
Ospedale San Salvatore, Coppitto-L'Aquila, , Italy
Istituto Nazionale dei Tumori, Milano, , Italy
Istituto Nazionale dei Tumori "G. Pascale", Napoli, , Italy
IFO Instituto Regina-Elena - IRCCS, Rome, , Italy
Istituto Dermopatico dell'Immacolata, Rome, , Italy
Azienda Ospedaliera Universitaria di Siena, Siena, , Italy
Szpital Akademii Medycznej w Gdansku, Gdansk, , Poland
Wielkopolskie Centrum Onkologii, Poznan, , Poland
Hospital Clinic I Provincial de Barcelona, Barcelona, , Spain
Hospital Germans Trias I Pujol, Barcelona, , Spain
Hospital Gregorio Maranon, Madrid, , Spain
Clinica Universitaria de Navarra, Navarra, , Spain
University Hospital Zurich, Zurich, , Switzerland
Guy's Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Nottingham University Hospitals NHS Trust, City Campus, Nottingham, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom