300
Participants
Start Date
July 31, 2007
Primary Completion Date
May 31, 2011
Study Completion Date
May 31, 2011
dacarbazine plus Genasense
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus Genasense group will receive Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the Genasense infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
dacarbazine plus placebo
Protocol therapy will be administered in 21-day cycles for up to 8 cycles. Subjects in the dacarbazine plus placebo group will receive placebo (that is, locally available commercial 0.9% Sodium Chloride Injection) by continuous intravenous infusion beginning on Day 1 and continuing for 5 days (120 hours) plus dacarbazine 1000 mg/m2 as a 60-minute intravenous infusion immediately following the conclusion of the placebo infusion. Subjects who are responding or have stable disease after 8 cycles of therapy may, at the Investigator's discretion, continue that same therapy for up to 8 additional cycles.
Sydney Cancer Center, Royal Prince Alfred Hospital, Camperdown
St. Luke's Cancer Center, Bethlehem
Thomas Jefferson University Hospital, Philadelphia
University of South Alabama Hospital, Mitchell Cancer Institute, Mobile
The West Clinic, Memphis
Siouxland Hematology Oncology Associates, Sioux City
Hematology Oncology Centers of the Northern Rockies, Billings
Cancer Care Associates, Oklahoma City
Cancer Care Associates, Site 1, Tulsa
Texas Oncology - Sammons Cancer Center, Dallas
San Diego Pacific Oncology and Hematology Associates Inc., Encinitas
Redwood Regional Medical Group, Inc., Santa Rosa
Dana Farber Cancer Institute, Boston
Morristown Memorial - Atlantic Healthcare System, Morristown
MD Anderson Cancer Center at University of Texas, Houston
Calvary Mater Newcastle, Newcastle
Westmead Hospital, Westmead
Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck, Innsbruck
Landesklinikum St. Polten, Sankt Pölten
Medical University of Vienna, Vienna General Hospital, Vienna
London Regional Cancer Program, London
Princess Margaret Hospital, Toronto
Charles University, Dermatology Department, Prague
CHU Saint Jacques, Besançon
Hopital Saint-Andre, Bordeaux
CHU Ambroise Pare, Boulogne-Billancourt
CHU Hotel Dieu, Clermont-Ferrand
CHU de Dijon, Hopital du Bocage Sud, Dijon
CHU de Grenoble, Hopital Albert Michallon, Grenoble
Centre Hospitalier du Mans, Le Mans
CHRU de Lille, Hopital Claude Huriez, Lille
Hopital de l'Hotel Dieu, Lyon
Hopital Sainte Marguerite, Marseille
Hopital Saint Eloi, Montpellier
CHU Hotel Dieu, Nantes
Hopital Saint-Louis, Paris
Hopital Robert Debre, Reims
CHU CH Nicolle, Rouen
Institut Gustave Roussy, Villejuif
Charite Universitatsmedizin Berlin, Berlin
Vivantes Klinikum im Friedrichshain, Berlin
Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie, Berlin
Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum, Bochum
Klinik und Poliklinik fur Dermatologie und Venerologie, Cologne
Helios Klinikum Erfurt, Erfurt
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen, Essen
Universitatsklinikum Freiburg, Freiburg im Breisgau
Hautklinik Linden, Hanover
Klinikum der Friedrich-Schiller-Universitat Jena, Jena
Universitatklinikum A. o. R., Leipzig
Hospital of the University of Schleswig-Holstein, Lübeck
Universitats-Hautklinik Mainz, Mainz
Universitatsklinikum Mannheim, Mannheim
Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie, Marburg
Klinik und Poliklinik fur Hautkrankheiten, Münster
Helios Vogtland-Klinikum Plauen, Plauen
Klinikum Quedlinburg, Quedlinburg
Dermatologische Klinik und Poliklinik, Regensburg
Hautklinik Universitat Tubingen, Tübingen
Ospedale San Salvatore, Coppitto-L'Aquila
Istituto Nazionale dei Tumori, Milan
"Istituto Nazionale dei Tumori G. Pascale", Napoli
IFO Instituto Regina-Elena - IRCCS, Rome
Istituto Dermopatico dell'Immacolata, Rome
Azienda Ospedaliera Universitaria di Siena, Siena
Szpital Akademii Medycznej w Gdansku, Gdansk
Wielkopolskie Centrum Onkologii, Poznan
Hospital Clinic I Provincial de Barcelona, Barcelona
Hospital Germans Trias I Pujol, Barcelona
Hospital Gregorio Maranon, Madrid
Clinica Universitaria de Navarra, Navarra
University Hospital Zurich, Zurich
Guy's Hospital, London
The Royal Marsden Hospital, London
Christie Hospital, Manchester
Nottingham University Hospitals NHS Trust, City Campus, Nottingham
Weston Park Hospital, Sheffield
Lead Sponsor
Genta Incorporated
INDUSTRY