Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
NCT ID: NCT00518895
Last Updated: 2011-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2007-07-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Dacarbazine with Genasense
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.
B
Dacarbazine with placebo
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genta Incorporated
INDUSTRY
Responsible Party
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Locations
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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
Sankt Pölten, , Austria
Medical University of Vienna, Vienna General Hospital
Vienna, , Austria
London Regional Cancer Program
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Charles University, Dermatology Department
Prague, , Czechia
CHU Saint Jacques
Besançon, , 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
Klinik und Poliklinik fur Dermatologie und Venerologie
Cologne, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
Essen, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Hautklinik Linden
Hanover, , Germany
Klinikum der Friedrich-Schiller-Universitat Jena
Jena, , Germany
Universitatklinikum A. o. R.
Leipzig, , Germany
Hospital of the University of Schleswig-Holstein
Lübeck, , 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
Münster, , Germany
Helios Vogtland-Klinikum Plauen
Plauen, , Germany
Klinikum Quedlinburg
Quedlinburg, , Germany
Dermatologische Klinik und Poliklinik
Regensburg, , Germany
Hautklinik Universitat Tubingen
Tübingen, , Germany
Ospedale San Salvatore
Coppitto-L'Aquila, , Italy
Istituto Nazionale dei Tumori
Milan, , 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
Countries
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References
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Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].
Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. doi: 10.1200/JCO.2006.06.0483. Epub 2006 Sep 11.
Other Identifiers
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GM307
Identifier Type: -
Identifier Source: secondary_id
AGENDA
Identifier Type: -
Identifier Source: org_study_id