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

November 4, 2011 updated by: Genta Incorporated

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Sydney Cancer Center, Royal Prince Alfred Hospital
      • Newcastle, New South Wales, Australia
        • Calvary Mater Newcastle
      • Westmead, New South Wales, Australia
        • Westmead Hospital
  • Austria
      • Innsbruck, Austria
        • Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
      • St. Polten, Austria
        • Landesklinikum St. Pölten
      • Wien, Austria
        • Medical University of Vienna, Vienna General Hospital
  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Regional Cancer Program
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
  • Czech Republic
      • Prague, Czech Republic
        • Charles University, Dermatology Department
  • France
      • Besancon, France
        • CHU Saint Jacques
      • Bordeaux, France
        • Hôpital Saint-André
      • Boulogne-Billancourt, France
        • CHU Ambroise Pare
      • Clermont Ferrand, France
        • Chu Hotel Dieu
      • Dijon, France
        • CHU de Dijon, Hopital du Bocage Sud
      • Grenoble, France
        • CHU de Grenoble, Hopital Albert Michallon
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lille, France
        • CHRU de Lille, Hôpital Claude Huriez
      • Lyon, France
        • Hôpital de l'Hôtel Dieu
      • Marseille, France
        • Hôpital Sainte Marguerite
      • Montpellier, France
        • Hopital Saint Eloi
      • Nantes, France
        • Chu Hotel Dieu
      • Paris, France
        • Hopital Saint-Louis
      • Reims, France
        • Hôpital Robert Debré
      • Rouen, France
        • CHU CH Nicolle
      • Villejuif, France
        • Institut Gustave Roussy
  • Germany
      • Berlin, Germany
        • Vivantes Klinikum im Friedrichshain
      • Berlin, Germany
        • Charité Universitätsmedizin Berlin
      • Berlin, Germany
        • Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
      • Bochum, Germany
        • Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
      • Erfurt, Germany
        • HELIOS Klinikum Erfurt
      • Essen, Germany
        • Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Hannover, Germany
        • Hautklinik Linden
      • Jena, Germany
        • Klinikum der Friedrich-Schiller-Universität Jena
      • Koln, Germany
        • Klinik und Poliklinik fur Dermatologie und Venerologie
      • Leipzig, Germany
        • Universitatklinikum A. o. R.
      • Lubeck, Germany
        • Hospital of the University of Schleswig-Holstein
      • Mainz, Germany
        • Universitats-Hautklinik Mainz
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Marburg, Germany
        • Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
      • Munster, Germany
        • Klinik und Poliklinik für Hautkrankheiten
      • Plauen, Germany
        • Helios Vogtland-Klinikum Plauen
      • Quedlinburg, Germany
        • Klinikum Quedlinburg
      • Regensburg, Germany
        • Dermatologische Klinik und Poliklinik
      • Tubingen, Germany
        • Hautklinik Universitat Tubingen
  • Italy
      • Coppitto-L'Aquila, Italy
        • Ospedale San Salvatore
      • Milano, Italy
        • Istituto Nazionale dei Tumori
      • Napoli, Italy
        • Istituto Nazionale dei Tumori "G. Pascale"
      • Rome, Italy
        • Istituto Dermopatico dell'Immacolata
      • Rome, Italy
        • IFO Instituto Regina-Elena - IRCCS
      • Siena, Italy
        • Azienda Ospedaliera Universitaria di Siena
  • Poland
      • Gdansk, Poland
        • Szpital Akademii Medycznej w Gdansku
      • Poznan, Poland
        • Wielkopolskie Centrum Onkologii
  • Spain
      • Barcelona, Spain
        • Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Madrid, Spain
        • Hospital Gregorio Marañon
      • Navarra, Spain
        • Clinica Universitaria de Navarra
  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich
  • United Kingdom
      • London, United Kingdom
        • Guy'S Hospital
      • London, United Kingdom
        • The Royal Marsden hospital
      • Manchester, United Kingdom
        • Christie Hospital
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust, City Campus
      • Sheffield, United Kingdom
        • Weston Park Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
        • University of South Alabama Hospital, Mitchell Cancer Institute
    • California
      • Encinitas, California, United States, 92024
        • San Diego Pacific Oncology and Hematology Associates Inc.
      • Santa Rosa, California, United States, 95403
        • Redwood Regional Medical Group, Inc.
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology Oncology Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Montana
      • Billings, Montana, United States, 59101
        • Hematology Oncology Centers of the Northern Rockies
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Memorial - Atlantic Healthcare System
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Care Associates
      • Tulsa, Oklahoma, United States, 74104
        • Cancer Care Associates, Site 1
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic
    • Texas
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Sammons Cancer Center
      • Houston, Texas, United States, 77030-4009
        • MD Anderson Cancer Center at University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Dacarbazine with Genasense
Drug: 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.
Other Names:
  • dacarbazine plus Genasense (oblimersen, G3139)
ACTIVE_COMPARATOR: B
Dacarbazine with placebo
Drug: 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 Names:
  • dacarbazine plus placebo (0.9% Sodium Chloride Injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival and overall survival
Time Frame: Every 42 days from date of randomization during protocol therapy
Every 42 days from date of randomization during protocol therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate, durable response rate, duration of response, safety
Time Frame: Response and progression every 42 days from date of randomization during protocol therapy
Response and progression every 42 days from date of randomization during protocol therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

August 14, 2007

First Submitted That Met QC Criteria

August 17, 2007

First Posted (ESTIMATE)

August 21, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 4, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGENDA
  • GM307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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