Prostate CancerPhase 3NCT00089856
GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase 3 study testing Immunotherapy with allogeneic prostate vaccine and Chemotherapy (Taxotere and prednisone) in people with Prostate Cancer, run by Cell Genesys at 126 sites in 8 countries.
Trial summary
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Immunotherapy with allogeneic prostate vaccine and Chemotherapy (Taxotere and prednisone)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 126 sitesin 8 countries
- Study dates
- Jul 2004to Oct 2008
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- Any Gleason score
- ECOG performance status 0-2
Who cannot join
- Prior treatment with chemotherapy
- Prior Immunotherapy
- Prior treatment with gene therapy
- Significant cancer related pain
Trial locations and contacts
126 sites in 8 countries.
126 sites in 8 countries
United States83 sites
Central Alabama Oncology, LLC
Alabaster, Alabama, 35007
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106
Alaska Clinical Research Center
Anchorage, Alaska, 99508
Atlanta VAMC
Atlanta, Georgia, 30033
Georgia Cancer Specialists
Atlanta, Georgia, 30084
Peachtree Hematology Oncology Consultants, PC
Atlanta, Georgia, 30309
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
Univ. of Colorado Health Science Center
Aurora, Colorado, 80045
Urologic Surgery PC
Bala-Cynwyd, Pennsylvania, 19004
Johns Hopkins University
Baltimore, Maryland, 21231
Southwestern Oncology Research Department
Bennington, Vermont, 05201
Deaconess Billings Clinic
Billings, Montana, 59101
Hematology/Oncology Centers of the Northern Rockies, P.C.
Billings, Montana, 59101
Medcenter One Cancer Care / Odyssey Research
Bismarck, North Dakota, 58501
Boca Raton Community Hospital, Inc.
Boca Raton, Florida, 33486
The Hope Clinic
Bristol, Connecticut, 06010
Gabrail Cancer Center
Canton, Ohio, 44718
Charleston Hematology Oncology
Charleston, South Carolina, 29403
Presbyterian Hospital/ Center for Cancer Research
Charlotte, North Carolina, 28204
Memorial Health Care System
Chattanooga, Tennessee, 37404
The Center for Cancer & Hematologic Disease
Cherry Hill, New Jersey, 08003
University of Illinois at Chicago
Chicago, Illinois, 60612
Cleveland Clinic Foundation, Taussig Cancer Center
Cleveland, Ohio, 44195
Cancer Center of Colorado Springs
Colorado Springs, Colorado, 80907
Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92882
Mary Crowley Medical Research Center
Dallas, Texas, 75201
Center for Oncology Research and Treatment PA
Dallas, Texas, 75230
Urology Specialists and Associates, P.A.
Dallas, Texas, 75231
Welborn Clinic Research Center
Evansville, Indiana, 47713
Dakota Cancer Institute
Fargo, North Dakota, 58103
Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Fort Wayne Medical Oncology/Hematology Inc.
Fort Wayne, Indiana, 46815
Pacific Coast Hem Onc. Medical Group
Fountain Valley, California, 92708
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701
West Michigan Regional Cancer and Blood Center
Free Soil, Michigan, 49411
Palo Verde Hematology/Oncology
Glendale, Arizona, 85304
California Cancer Care
Greenbrae, California, 94904
Northwestern Carolina Hematology Oncology, PA
Hickory, North Carolina, 28602
Straub Clinic & Hospital
Honolulu, Hawaii, 96813
Mobley Research Center
Houston, Texas, 77024
Integrated Community Oncology Network
Jacksonville, Florida, 32256
Medical Oncology Associates
Kingston, Pennsylvania, 18704
Center for Urological Research
La Mesa, California, 91942
Louisiana Oncology Associates
Lafayette, Louisiana, 70506
Lancaster Cancer Center, Ltd
Lancaster, Pennsylvania, 17601
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Arkansas Cancer Research Center
Little Rock, Arkansas, 72205
Central Georgia Cancer Care, P.C.
Macon, Georgia, 31201
The West Clinic
Memphis, Tennessee, 38120
Oncology-Hematology Group of South Florida/Advanced Medical Specialists
Miami, Florida, 33176
Oncology Care Medical Associates
Montebello, California, 90640
Hematology-Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07962
Urology Center of Grove Hill
New Britain, Connecticut, 06052-1395
Columbia University Medical Center
New York, New York, 10032
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida
Ocoee, Florida, 34761
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Omaha VA Medical Center
Omaha, Nebraska, 68105
Omaha VA Medical Center
Omaha, Nebraska, 68198-7680
UC Irvine Medical Center
Orange, California, 92868
University of Pittsburgh Cancer Center
Pittsburgh, Pennsylvania, 15232
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Providence Portland Medical Center
Portland, Oregon, 97213
William Beaumont Hospital, Cancer Clinical Trials Office
Royal Oak, Michigan, 48073-6706
Urology Consultants
Safety Harbor, Florida, 34695
Urology San Antonio
San Antonio, Texas, 78229
San Bernardino Urological Associates
San Bernardino, California, 92404
Sharp Healthcare
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
Virginia Mason Medical Center Urology
Seattle, Washington, 98101
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Cancer Research & Prevention Center
Soquel, California, 95073
Newland Medical Associates, P.C.
Southfield, Michigan, 48075
Hematology Oncology Consultants, Inc.
St Louis, Missouri, 63136
Carl & Dorothy Bennett Cancer Center
Stamford, Connecticut, 06902
Summit Medical Group/Overlook Oncology Center
Summit, New Jersey, 07901
SUNY Upstate Medical University
Syracuse, New York, 13210
Jacobi Medical Center
The Bronx, New York, 10461
ACRC/Arizona Clinical Res. Ctr. Inc.
Tuscon, Arizona, 85715
Tyler Cancer Center
Tyler, Texas, 75702
San Diego Cancer Center
Vista, California, 92081
United Kingdom12 sites
Addenbrooke's Hospital
Cambridge, CB2 2QQ
Beatson Oncology Centre
Glasgow, G11 6NT
St. James's University Hospital
Leeds, LS97TF
Hammersmith Hospital
London, W12 0NN
Mount Vernon Hospital
Middlesex, HA6 2RN
Newcastle General Hospital
Newcastle upon Tyne, NE4 6BE
Northampton General Hosptial
Northampton, NN1 5BD
Nottingham City Hospital
Nottingham, NG5 1PB
Oxford Cancer Centre, Churchill Hospital
Oxford, OX3 7LT
Scunthorpe General Hospital
Scunthorpe, DN15 7BH
Royal Hallamshire Hospital
Sheffield, S10 2JF
Glan Clwyd Hospital
Wales, LL18 5UJ
Belgium9 sites
ZNA Middelheim
Antwerp, B-2020
Imelda Ziekenhuis
Bonheiden, 2820
University Hospital Antwerp (UZA)
Edegem, 2650
UZ Gent
Ghent, 9000
Unversity Hospial Gent
Ghent, B-9000
Virga Jesse Ziekenhuis
Hasselt, B-3500
AZ Groeninge
Kortrijk, B-8500
Heilig Hartziekenhuis Roeselare Men
Roeselare, B-8800
Regionaal Ziekenhuis Sint Trudo
Sint-Truiden, B-3800
France8 sites
Centre Paul Papin
Angers, 49033
Centre Francois Baclesse
Caen, 14076
Centre Georges Francois Leclerc
Dijon, 77980
Centre Leon Berard Service de Cancerologie Medicale
Lyon, 08
Institut Paoli-Calmettes
Marseille, 13009
Centre Rene Gauducheau
Nantes-Saint Herblain, 44805
Institut Jean Godinot
Reims, 51056
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
Canada5 sites
CHUM Notre-Dam
Montreal, Quebec, H2L 4M1
McGill University
Montreal, Quebec, H2W1S6
Ultra Med Inc.
Pointe-Claire, Quebec, H9R 4S3
Centre Hopitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Germany4 sites
Universitatsklinikum Aachen Urologie
Aachen, 52074
der Technischen Universitat Dresden
Dresden, 1307
Universitatsklinik um Essen
Essen, 45122
Universitatsklinik um des Saarlande
Homburg/Saar, 66421
Sweden3 sites
University Hospital, Linkoping
Linköping
University Hospital Lund
Lund
Akademiska University Hospital
Uppsala, 85
Netherlands2 sites
VU Medisch Centrum
Amsterdam, 1081 HV
University Medical Centre Groningen
Groningen
About this study
Official title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.
- Conditions
- Prostate Cancer
- Being tested
- Immunotherapy with allogeneic prostate vaccine, Chemotherapy (Taxotere and prednisone)
- Keywords
- Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells, Advanced Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy with allogeneic prostate vaccineBiological
Immunotherapy with allogeneic prostate vaccine
Chemotherapy (Taxotere and prednisone)Drug
Chemotherapy (Taxotere and prednisone)
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | Standard of care - chemotherapy Receives: Drug: Chemotherapy (Taxotere and prednisone) |
| 1 | Experimental | Immunotherapy Receives: Biological: Immunotherapy with allogeneic prostate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 0
Secondary outcomes (1)
Bone pain and bone related events
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2004 (estimated)
- Study startJul 2004
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Based on futility analysis showing \<30% chance of meeting primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Genesys
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089856
- Sponsor's protocol ID
- G-0029
- Other IDs
- (VITAL-1)
- Status last verified
- Nov 2008
- First submitted
- 16 Aug 2004
- Last updated
- 5 Nov 2008
- Results posted
- No
Publications
Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.
PubMed 23740935
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve
- ClinicalTrials.gov ID
- NCT00089856
- Acronym / sponsor ID
- G-0029
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on futility analysis showing \<30% chance of meeting primary endpoint.
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Cell GenesysIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 18 Aug 2004 (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.
The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Drug: Chemotherapy (Taxotere and prednisone)Standard of care - chemotherapy |
| 1 | Experimental | Biological: Immunotherapy with allogeneic prostate vaccineImmunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
- Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
- Detectable metastases
- Any Gleason score
- ECOG performance status 0-2
Key exclusion criteria (4 listed)
- Prior treatment with chemotherapy
- Prior Immunotherapy
- Prior treatment with gene therapy
- Significant cancer related pain
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 |
|---|---|---|
| Immunotherapy with allogeneic prostate vaccineImmunotherapy with allogeneic prostate vaccine | Biological | 1 |
| Chemotherapy (Taxotere and prednisone)Chemotherapy (Taxotere and prednisone) | Drug | 2 |
Primary outcome
Survival
Time frame: 0
1 secondary outcome
Bone pain and bone related events
Time frame: 0
Results and safety
The study was stopped early (reason given: Based on futility analysis showing \<30% chance of meeting primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2008.
- Derived from this study: PubMed 23740935Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5.
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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.
126 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Immunotherapy with allogeneic prostate vaccine and Chemotherapy (Taxotere and prednisone) in people with Prostate Cancer, run by Cell Genesys at 126 sites in 8 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 5 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 126 sites in United States, United Kingdom, Belgium, France, Canada and 3 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 was stopped early (reason given: Based on futility analysis showing \<30% chance of meeting primary endpoint.). Results are not available in the source record.
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?
Survival (time frame: 0). 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 NCT00089856, which also lists 1 linked publication.
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 5 Nov 2008.