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Trial of Dacarbazine With or Without Genasense in Advanced Melanoma (AGENDA)

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dacarbazine plus Genasense
dacarbazine plus placebo
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Advanced Melanoma, Malignant Melanoma, Metastatic Melanoma, Skin Cancer, Genasense, oblimersen, antisense, Bcl-2 antisense, G3139, dacarbazine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama Hospital, Mitchell Cancer Institute
  • San Diego Pacific Oncology and Hematology Associates Inc.
  • Redwood Regional Medical Group, Inc.
  • Siouxland Hematology Oncology Associates
  • Dana Farber Cancer Institute
  • Hematology Oncology Centers of the Northern Rockies
  • Morristown Memorial - Atlantic Healthcare System
  • Cancer Care Associates
  • Cancer Care Associates, Site 1
  • St. Luke's Cancer Center
  • Thomas Jefferson University Hospital
  • The West Clinic
  • Texas Oncology - Sammons Cancer Center
  • MD Anderson Cancer Center at University of Texas
  • Sydney Cancer Center, Royal Prince Alfred Hospital
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
  • Landesklinikum St. Polten
  • Medical University of Vienna, Vienna General Hospital
  • London Regional Cancer Program
  • Princess Margaret Hospital
  • Charles University, Dermatology Department
  • CHU Saint Jacques
  • Hopital Saint-Andre
  • CHU Ambroise Pare
  • CHU Hotel Dieu
  • CHU de Dijon, Hopital du Bocage Sud
  • CHU de Grenoble, Hopital Albert Michallon
  • Centre Hospitalier du Mans
  • CHRU de Lille, Hopital Claude Huriez
  • Hopital de l'Hotel Dieu
  • Hopital Sainte Marguerite
  • Hopital Saint Eloi
  • CHU Hotel Dieu
  • Hopital Saint-Louis
  • Hopital Robert Debre
  • CHU CH Nicolle
  • Institut Gustave Roussy
  • Charite Universitatsmedizin Berlin
  • Vivantes Klinikum im Friedrichshain
  • Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
  • Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
  • Helios Klinikum Erfurt
  • Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
  • Universitatsklinikum Freiburg
  • Hautklinik Linden
  • Klinikum der Friedrich-Schiller-Universitat Jena
  • Klinik und Poliklinik fur Dermatologie und Venerologie
  • Universitatklinikum A. o. R.
  • Hospital of the University of Schleswig-Holstein
  • Universitats-Hautklinik Mainz
  • Universitatsklinikum Mannheim
  • Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
  • Klinik und Poliklinik fur Hautkrankheiten
  • Helios Vogtland-Klinikum Plauen
  • Klinikum Quedlinburg
  • Dermatologische Klinik und Poliklinik
  • Hautklinik Universitat Tubingen
  • Ospedale San Salvatore
  • Istituto Nazionale dei Tumori
  • Istituto Nazionale dei Tumori "G. Pascale"
  • IFO Instituto Regina-Elena - IRCCS
  • Istituto Dermopatico dell'Immacolata
  • Azienda Ospedaliera Universitaria di Siena
  • Szpital Akademii Medycznej w Gdansku
  • Wielkopolskie Centrum Onkologii
  • Hospital Clinic I Provincial de Barcelona
  • Hospital Germans Trias I Pujol
  • Hospital Gregorio Maranon
  • Clinica Universitaria de Navarra
  • University Hospital Zurich
  • Guy's Hospital
  • The Royal Marsden Hospital
  • Christie Hospital
  • Nottingham University Hospitals NHS Trust, City Campus
  • Weston Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Dacarbazine with Genasense

Dacarbazine with placebo

Outcomes

Primary Outcome Measures

Progression-free survival and overall survival

Secondary Outcome Measures

Response rate, durable response rate, duration of response, safety

Full Information

First Posted
August 14, 2007
Last Updated
November 4, 2011
Sponsor
Genta Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00518895
Brief Title
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
Acronym
AGENDA
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

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genta Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Advanced Melanoma, Malignant Melanoma, Metastatic Melanoma, Skin Cancer, Genasense, oblimersen, antisense, Bcl-2 antisense, G3139, dacarbazine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Dacarbazine with Genasense
Arm Title
B
Arm Type
Active Comparator
Arm Description
Dacarbazine with placebo
Intervention Type
Drug
Intervention Name(s)
dacarbazine plus Genasense
Other Intervention Name(s)
dacarbazine plus Genasense (oblimersen, G3139)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
dacarbazine plus placebo
Other Intervention Name(s)
dacarbazine plus placebo (0.9% Sodium Chloride Injection)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival and overall survival
Time Frame
Every 42 days from date of randomization during protocol therapy
Secondary Outcome Measure Information:
Title
Response rate, durable response rate, duration of response, safety
Time Frame
Response and progression every 42 days from date of randomization during protocol therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of South Alabama Hospital, Mitchell Cancer Institute
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
San Diego Pacific Oncology and Hematology Associates Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Redwood Regional Medical Group, Inc.
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Siouxland Hematology Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hematology Oncology Centers of the Northern Rockies
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Morristown Memorial - Atlantic Healthcare System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates, Site 1
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
St. Luke's Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Texas Oncology - Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
MD Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Sydney Cancer Center, Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Landesklinikum St. Polten
City
St. Polten
Country
Austria
Facility Name
Medical University of Vienna, Vienna General Hospital
City
Wien
Country
Austria
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Charles University, Dermatology Department
City
Prague
Country
Czech Republic
Facility Name
CHU Saint Jacques
City
Besancon
Country
France
Facility Name
Hopital Saint-Andre
City
Bordeaux
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne-Billancourt
Country
France
Facility Name
CHU Hotel Dieu
City
Clermont Ferrand
Country
France
Facility Name
CHU de Dijon, Hopital du Bocage Sud
City
Dijon
Country
France
Facility Name
CHU de Grenoble, Hopital Albert Michallon
City
Grenoble
Country
France
Facility Name
Centre Hospitalier du Mans
City
Le Mans
Country
France
Facility Name
CHRU de Lille, Hopital Claude Huriez
City
Lille
Country
France
Facility Name
Hopital de l'Hotel Dieu
City
Lyon
Country
France
Facility Name
Hopital Sainte Marguerite
City
Marseille
Country
France
Facility Name
Hopital Saint Eloi
City
Montpellier
Country
France
Facility Name
CHU Hotel Dieu
City
Nantes
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
Country
France
Facility Name
Hopital Robert Debre
City
Reims
Country
France
Facility Name
CHU CH Nicolle
City
Rouen
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
Country
France
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
City
Berlin
Country
Germany
Facility Name
Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
City
Bochum
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
Country
Germany
Facility Name
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
City
Essen
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
Country
Germany
Facility Name
Hautklinik Linden
City
Hannover
Country
Germany
Facility Name
Klinikum der Friedrich-Schiller-Universitat Jena
City
Jena
Country
Germany
Facility Name
Klinik und Poliklinik fur Dermatologie und Venerologie
City
Koln
Country
Germany
Facility Name
Universitatklinikum A. o. R.
City
Leipzig
Country
Germany
Facility Name
Hospital of the University of Schleswig-Holstein
City
Lubeck
Country
Germany
Facility Name
Universitats-Hautklinik Mainz
City
Mainz
Country
Germany
Facility Name
Universitatsklinikum Mannheim
City
Mannheim
Country
Germany
Facility Name
Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
City
Marburg
Country
Germany
Facility Name
Klinik und Poliklinik fur Hautkrankheiten
City
Munster
Country
Germany
Facility Name
Helios Vogtland-Klinikum Plauen
City
Plauen
Country
Germany
Facility Name
Klinikum Quedlinburg
City
Quedlinburg
Country
Germany
Facility Name
Dermatologische Klinik und Poliklinik
City
Regensburg
Country
Germany
Facility Name
Hautklinik Universitat Tubingen
City
Tubingen
Country
Germany
Facility Name
Ospedale San Salvatore
City
Coppitto-L'Aquila
Country
Italy
Facility Name
Istituto Nazionale dei Tumori
City
Milano
Country
Italy
Facility Name
Istituto Nazionale dei Tumori "G. Pascale"
City
Napoli
Country
Italy
Facility Name
IFO Instituto Regina-Elena - IRCCS
City
Rome
Country
Italy
Facility Name
Istituto Dermopatico dell'Immacolata
City
Rome
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Siena
City
Siena
Country
Italy
Facility Name
Szpital Akademii Medycznej w Gdansku
City
Gdansk
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznan
Country
Poland
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Germans Trias I Pujol
City
Barcelona
Country
Spain
Facility Name
Hospital Gregorio Maranon
City
Madrid
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Navarra
Country
Spain
Facility Name
University Hospital Zurich
City
Zurich
Country
Switzerland
Facility Name
Guy's Hospital
City
London
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust, City Campus
City
Nottingham
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
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].
Results Reference
background
PubMed Identifier
16966688
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.
Results Reference
background

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Trial of Dacarbazine With or Without Genasense in Advanced Melanoma

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