Clinical trial NCT00518895: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Melanoma
Advanced Melanoma
Malignant Melanoma
Metastatic Melanoma
Skin Cancer
Genasense
oblimersen
antisense
Bcl-2 antisense
G3139
dacarbazine
Lead sponsor: Genta Incorporated
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival and overall survival
timeFrame: Every 42 days from date of randomization during protocol therapy
Secondary outcomes:
measure: Response rate, durable response rate, duration of response, safety
timeFrame: Response and progression every 42 days from date of randomization during protocol therapy
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Hospital, Mitchell Cancer Institute
state: Alabama
city: Encinitas
country: United States
facility: San Diego Pacific Oncology and Hematology Associates Inc.
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group, Inc.
state: California
city: Sioux City
country: United States
facility: Siouxland Hematology Oncology Associates
state: Iowa
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Morristown
country: United States
facility: Morristown Memorial - Atlantic Healthcare System
state: New Jersey
city: Oklahoma City
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates, Site 1
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke's Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center at University of Texas
state: Texas
city: Camperdown
country: Australia
facility: Sydney Cancer Center, Royal Prince Alfred Hospital
state: New South Wales
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Innsbruck
country: Austria
facility: Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
city: St. Polten
country: Austria
facility: Landesklinikum St. Polten
city: Wien
country: Austria
facility: Medical University of Vienna, Vienna General Hospital
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Prague
country: Czech Republic
facility: Charles University, Dermatology Department
city: Besancon
country: France
facility: CHU Saint Jacques
city: Bordeaux
country: France
facility: Hopital Saint-Andre
city: Boulogne-Billancourt
country: France
facility: CHU Ambroise Pare
city: Clermont Ferrand
country: France
facility: CHU Hotel Dieu
city: Dijon
country: France
facility: CHU de Dijon, Hopital du Bocage Sud
city: Grenoble
country: France
facility: CHU de Grenoble, Hopital Albert Michallon
city: Le Mans
country: France
facility: Centre Hospitalier du Mans
city: Lille
country: France
facility: CHRU de Lille, Hopital Claude Huriez
city: Lyon
country: France
facility: Hopital de l'Hotel Dieu
city: Marseille
country: France
facility: Hopital Sainte Marguerite
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nantes
country: France
facility: CHU Hotel Dieu
city: Paris
country: France
facility: Hopital Saint-Louis
city: Reims
country: France
facility: Hopital Robert Debre
city: Rouen
country: France
facility: CHU CH Nicolle
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
city: Bochum
country: Germany
facility: Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Essen
country: Germany
facility: Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hannover
country: Germany
facility: Hautklinik Linden
city: Jena
country: Germany
facility: Klinikum der Friedrich-Schiller-Universitat Jena
city: Koln
country: Germany
facility: Klinik und Poliklinik fur Dermatologie und Venerologie
city: Leipzig
country: Germany
facility: Universitatklinikum A. o. R.
city: Lubeck
country: Germany
facility: Hospital of the University of Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitats-Hautklinik Mainz
city: Mannheim
country: Germany
facility: Universitatsklinikum Mannheim
city: Marburg
country: Germany
facility: Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
city: Munster
country: Germany
facility: Klinik und Poliklinik fur Hautkrankheiten
city: Plauen
country: Germany
facility: Helios Vogtland-Klinikum Plauen
city: Quedlinburg
country: Germany
facility: Klinikum Quedlinburg
city: Regensburg
country: Germany
facility: Dermatologische Klinik und Poliklinik
city: Tubingen
country: Germany
facility: Hautklinik Universitat Tubingen
city: Coppitto-L'Aquila
country: Italy
facility: Ospedale San Salvatore
city: Milano
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori "G. Pascale"
city: Rome
country: Italy
facility: IFO Instituto Regina-Elena - IRCCS
city: Rome
country: Italy
facility: Istituto Dermopatico dell'Immacolata
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria di Siena
city: Gdansk
country: Poland
facility: Szpital Akademii Medycznej w Gdansku
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hospital Gregorio Maranon
city: Navarra
country: Spain
facility: Clinica Universitaria de Navarra
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, City Campus
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
Study officials:
References:
citation: 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].
citation: 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.