MelanomaPhase 3AGENDANCT00518895
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma
A Phase 3 study testing dacarbazine plus Genasense in people with Melanoma, run by Genta Incorporated at 77 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- dacarbazine plus Genasense
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 77 sitesin 12 countries
- Study dates
- Jul 2007to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
77 sites in 12 countries.
77 sites in 12 countries
Germany20 sites
Charite Universitatsmedizin Berlin
Berlin
Vivantes Klinikum im Friedrichshain
Berlin
Vivantes Klinikum Neukoln, Klinik fur Dermatologie und Venerologie
Berlin
Klinik fur Dermatologie und Allergologie der Ruhr-Universitat Bochum
Bochum
Klinik und Poliklinik fur Dermatologie und Venerologie
Cologne
Helios Klinikum Erfurt
Erfurt
Klinik fur Dermatologie, Allergologie und Venerologie, Universitatsklinikum Essen
Essen
Universitatsklinikum Freiburg
Freiburg im Breisgau
Hautklinik Linden
Hanover
Klinikum der Friedrich-Schiller-Universitat Jena
Jena
Universitatklinikum A. o. R.
Leipzig
Hospital of the University of Schleswig-Holstein
Lübeck
Universitats-Hautklinik Mainz
Mainz
Universitatsklinikum Mannheim
Mannheim
Universitatsklinikum Giessen und Marburg GmbH, Klinik fur Dermatologie und Allergologie
Marburg
Klinik und Poliklinik fur Hautkrankheiten
Münster
Helios Vogtland-Klinikum Plauen
Plauen
Klinikum Quedlinburg
Quedlinburg
Dermatologische Klinik und Poliklinik
Regensburg
Hautklinik Universitat Tubingen
Tübingen
France16 sites
CHU Saint Jacques
Besançon
Hopital Saint-Andre
Bordeaux
CHU Ambroise Pare
Boulogne-Billancourt
CHU Hotel Dieu
Clermont-Ferrand
CHU de Dijon, Hopital du Bocage Sud
Dijon
CHU de Grenoble, Hopital Albert Michallon
Grenoble
Centre Hospitalier du Mans
Le Mans
CHRU de Lille, Hopital Claude Huriez
Lille
Hopital de l'Hotel Dieu
Lyon
Hopital Sainte Marguerite
Marseille
Hopital Saint Eloi
Montpellier
CHU Hotel Dieu
Nantes
Hopital Saint-Louis
Paris
Hopital Robert Debre
Reims
CHU CH Nicolle
Rouen
Institut Gustave Roussy
Villejuif
United States14 sites
St. Luke's Cancer Center
Bethlehem, Pennsylvania, 18015
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Texas Oncology - Sammons Cancer Center
Dallas, Texas, 75246
San Diego Pacific Oncology and Hematology Associates Inc.
Encinitas, California, 92024
MD Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
The West Clinic
Memphis, Tennessee, 38120
University of South Alabama Hospital, Mitchell Cancer Institute
Mobile, Alabama, 36607
Morristown Memorial - Atlantic Healthcare System
Morristown, New Jersey, 07960
Cancer Care Associates
Oklahoma City, Oklahoma, 73112
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Redwood Regional Medical Group, Inc.
Santa Rosa, California, 95403
Siouxland Hematology Oncology Associates
Sioux City, Iowa, 51101
Cancer Care Associates, Site 1
Tulsa, Oklahoma, 74104
Italy6 sites
Ospedale San Salvatore
Coppitto-L'Aquila
Istituto Nazionale dei Tumori
Milan
Istituto Nazionale dei Tumori "G. Pascale"
Naples
IFO Instituto Regina-Elena - IRCCS
Rome
Istituto Dermopatico dell'Immacolata
Rome
Azienda Ospedaliera Universitaria di Siena
Siena
United Kingdom5 sites
Guy's Hospital
London
The Royal Marsden Hospital
London
Christie Hospital
Manchester
Nottingham University Hospitals NHS Trust, City Campus
Nottingham
Weston Park Hospital
Sheffield
Spain4 sites
Hospital Clinic I Provincial de Barcelona
Barcelona
Hospital Germans Trias I Pujol
Barcelona
Hospital Gregorio Maranon
Madrid
Clinica Universitaria de Navarra
Navarra
Australia3 sites
Sydney Cancer Center, Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Calvary Mater Newcastle
Newcastle, New South Wales
Westmead Hospital
Westmead, New South Wales
Austria3 sites
Universitatsklinik fur Dermatologie und Venerologie, Medizinische Universitat Innsbruck
Innsbruck
Landesklinikum St. Polten
Sankt Pölten
Medical University of Vienna, Vienna General Hospital
Vienna
Canada2 sites
London Regional Cancer Program
London, Ontario
Princess Margaret Hospital
Toronto, Ontario
Poland2 sites
Szpital Akademii Medycznej w Gdansku
Gdansk
Wielkopolskie Centrum Onkologii
Poznan
About this study
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)
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.
- Conditions
- Melanoma
- Being tested
- dacarbazine plus Genasense, dacarbazine plus placebo
- Keywords
- Melanoma, Advanced Melanoma, Malignant Melanoma, Metastatic Melanoma, Skin Cancer, Genasense, oblimersen, antisense, Bcl-2 antisense, G3139, dacarbazine
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dacarbazine plus GenasenseDrug
Also called dacarbazine plus Genasense (oblimersen, G3139)
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 placeboDrug
Also called dacarbazine plus placebo (0.9% Sodium Chloride Injection)
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Dacarbazine with Genasense Receives: Drug: dacarbazine plus Genasense |
| B | Active comparator | Dacarbazine with placebo Receives: Drug: dacarbazine plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival and overall survival
Measured: Every 42 days from date of randomization during protocol therapy
Secondary outcomes (1)
Response rate, durable response rate, duration of response, safety
Measured: Response and progression every 42 days from date of randomization during protocol therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genta Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518895
- Sponsor's protocol ID
- AGENDA
- Other IDs
- GM307
- Acronym
- AGENDA
- Status last verified
- Apr 2009
- First submitted
- 14 Aug 2007
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16966688
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00518895
- Acronym / sponsor ID
- AGENDA / AGENDA
- Conditions
- Melanoma
- Keywords
- Melanoma, Advanced Melanoma, Malignant Melanoma, Metastatic Melanoma, Skin Cancer, Genasense, oblimersen, antisense
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Genta IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 21 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: dacarbazine plus GenasenseDacarbazine with Genasense |
| B | Active comparator | Drug: dacarbazine plus placeboDacarbazine with placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dacarbazine plus GenasenseAlso: dacarbazine plus Genasense (oblimersen, G3139)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. | Drug | A |
| dacarbazine plus placeboAlso: dacarbazine plus placebo (0.9% Sodium Chloride Injection)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. | Drug | B |
Primary outcome
Progression-free survival and overall survival
Time frame: Every 42 days from date of randomization during protocol therapy
1 secondary outcome
Response rate, durable response rate, duration of response, safety
Time frame: Response and progression every 42 days from date of randomization during protocol therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
- BackgroundBedikian 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].
- Background: PubMed 16966688Bedikian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
77 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dacarbazine plus Genasense in people with Melanoma, run by Genta Incorporated at 77 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Germany, France, United States, Italy, United Kingdom and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival and overall survival (time frame: Every 42 days from date of randomization during protocol therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00518895, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2011.