Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
- Conditions
- Melanoma
- Interventions
- Registration Number
- NCT00518895
- Lead Sponsor
- Genta Incorporated
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Histologically confirmed diagnosis of melanoma
- Progressive disease that is not surgically resectable, or metastatic Stage IV
- Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal
- No prior chemotherapy
- Measurable disease
- ECOG performance status ≤ 1
- At least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy
- Prior immunotherapy allowed
- Adequate organ function
- Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense treatment
- Primary ocular or mucosal melanoma
- Bone-only metastatic disease
- History or presence of brain metastasis or leptomeningeal disease
- Significant medical disease other than cancer
- Organ allograft
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A dacarbazine plus Genasense Dacarbazine with Genasense B dacarbazine plus placebo Dacarbazine with placebo
- Primary Outcome Measures
Name Time Method Progression-free survival and overall survival Every 42 days from date of randomization during protocol therapy
- Secondary Outcome Measures
Name Time Method Response rate, durable response rate, duration of response, safety Response and progression every 42 days from date of randomization during protocol therapy
Trial Locations
- Locations (76)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Texas Oncology - Sammons Cancer Center
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Hematology Oncology Centers of the Northern Rockies
🇺🇸Billings, Montana, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Medical University of Vienna, Vienna General Hospital
🇦🇹Wien, Austria
Wielkopolskie Centrum Onkologii
🇵🇱Poznan, Poland
The Royal Marsden Hospital
🇬🇧London, United Kingdom
Klinik und Poliklinik fur Hautkrankheiten
🇩🇪Munster, Germany
Cancer Care Associates, Site 1
🇺🇸Tulsa, Oklahoma, United States
Istituto Nazionale dei Tumori "G. Pascale"
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria di Siena
🇮🇹Siena, Italy
Hopital Sainte Marguerite
🇫🇷Marseille, France
San Diego Pacific Oncology and Hematology Associates Inc.
🇺🇸Encinitas, California, United States
Hospital Germans Trias I Pujol
🇪🇸Barcelona, Spain
University of South Alabama Hospital, Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
Szpital Akademii Medycznej w Gdansku
🇵🇱Gdansk, Poland
University Hospital Zurich
🇨🇭Zurich, Switzerland
Ospedale San Salvatore
🇮🇹Coppitto-L'Aquila, Italy
Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
🇩🇪Marburg, Germany
Hautklinik Universitat Tubingen
🇩🇪Tubingen, Germany
Clinica Universitaria de Navarra
🇪🇸Navarra, Spain
Klinikum Quedlinburg
🇩🇪Quedlinburg, Germany
Hospital Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Clinic I Provincial de Barcelona
🇪🇸Barcelona, Spain
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Charles University, Dermatology Department
🇨🇿Prague, Czech Republic
Morristown Memorial - Atlantic Healthcare System
🇺🇸Morristown, New Jersey, United States
Helios Vogtland-Klinikum Plauen
🇩🇪Plauen, Germany
Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
Siouxland Hematology Oncology Associates
🇺🇸Sioux City, Iowa, United States
CHU Hotel Dieu
🇫🇷Nantes, France
Dermatologische Klinik und Poliklinik
🇩🇪Regensburg, Germany
Universitatsklinikum Mannheim
🇩🇪Mannheim, Germany
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
IFO Instituto Regina-Elena - IRCCS
🇮🇹Rome, Italy
Istituto Dermopatico dell'Immacolata
🇮🇹Rome, Italy
Nottingham University Hospitals NHS Trust, City Campus
🇬🇧Nottingham, United Kingdom
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Cancer Care Associates
🇺🇸Oklahoma City, Oklahoma, United States
Landesklinikum St. Polten
🇦🇹St. Polten, Austria
St. Luke's Cancer Center
🇺🇸Bethlehem, Pennsylvania, United States
Calvary Mater Newcastle
🇦🇺Newcastle, New South Wales, Australia
Hopital Saint-Andre
🇫🇷Bordeaux, France
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
CHU Saint Jacques
🇫🇷Besancon, France
Sydney Cancer Center, Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
CHU de Dijon, Hopital du Bocage Sud
🇫🇷Dijon, France
CHU Ambroise Pare
🇫🇷Boulogne-Billancourt, France
CHRU de Lille, Hopital Claude Huriez
🇫🇷Lille, France
Hopital Saint Eloi
🇫🇷Montpellier, France
Hopital de l'Hotel Dieu
🇫🇷Lyon, France
Hopital Robert Debre
🇫🇷Reims, France
CHU de Grenoble, Hopital Albert Michallon
🇫🇷Grenoble, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
CHU CH Nicolle
🇫🇷Rouen, France
Institut Gustave Roussy
🇫🇷Villejuif, France
Hopital Saint-Louis
🇫🇷Paris, France
Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
🇩🇪Berlin, Germany
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Helios Klinikum Erfurt
🇩🇪Erfurt, Germany
Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
🇩🇪Bochum, Germany
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
🇩🇪Essen, Germany
Universitatsklinikum Freiburg
🇩🇪Freiburg, Germany
Klinikum der Friedrich-Schiller-Universitat Jena
🇩🇪Jena, Germany
Hautklinik Linden
🇩🇪Hannover, Germany
Universitatklinikum A. o. R.
🇩🇪Leipzig, Germany
Hospital of the University of Schleswig-Holstein
🇩🇪Lubeck, Germany
Klinik und Poliklinik fur Dermatologie und Venerologie
🇩🇪Koln, Germany
Universitats-Hautklinik Mainz
🇩🇪Mainz, Germany
Redwood Regional Medical Group, Inc.
🇺🇸Santa Rosa, California, United States
Christie Hospital
🇬🇧Manchester, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom