Prostate CancerPhase 3NCT00133224

Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

A Phase 3 study testing Immunotherapy allogeneic GM-CSF secreting cellular vaccine and Chemotherapy (docetaxel and prednisone) in people with Prostate Cancer, run by Cell Genesys at 115 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have… 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 allogeneic GM-CSF secreting cellular vaccine and Chemotherapy (docetaxel and prednisone)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 408 participants
Where: 115 sitesin 10 countries
Study dates: Jul 2005to Jun 2009
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
ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
Any Gleason score
Only one prior treatment with systemic chemotherapy

Show all 10Show fewer

No prior treatment with gene therapy
No prior immunotherapy for prostate cancer
Taxane naïve
Experiencing cancer-related pain

Who cannot join

None listed.

Trial locations and contacts

115 sites in 10 countries.

Country

City, postcode or hospital

115 sites in 10 countries

United States43 sites

New Mexico Oncology
Albuquerque, New Mexico, 87109
Alaska Clinical Research Center
Anchorage, Alaska, 99508
General Clinical Research Center University of Michigan
Ann Arbor, Michigan, 48109
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Peachtree Hematology & Oncology Consultants, PC
Atlanta, Georgia, 30309
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Cancer Center and Department of Medicine
Aurora, Colorado, 80010
Billings Clinic
Billings, Montana, 59101
Gabrail Cancer Center
Canton, Ohio, 44718
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28204
Center for Oncology Research & Treatment, PA
Dallas, Texas, 75230
Dallas Oncology Consultants
Dallas, Texas, 75237
Mary Crowley Medical Research Center
Dallas, Texas, 75246
North Shore Hematology Oncology Associates P.C.
East Setauket, New York, 11733
St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72917
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701
Medical & Surgical Specialists
Galesburg, Illinois, 61401
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mobley Research Center
Houston, Texas, 77024
Northwest Cancer Center
Houston, Texas, 77042
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Jupiter Hematology & Oncology Associates
Jupiter, Florida, 33458
Lakeland Regional Cancer Center
Lakeland, Florida, 33804
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Loma Linda University
Loma Linda, California, 92354
Onocology Care Medical Associates
Los Angeles, California, 90057
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
The West Clinic
Memphis, Tennessee, 38120
NYU Clinical Cancer Center
New York, New York, 10016
Hematology & Oncology Consultants P.C.
Omaha, Nebraska, 68122
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Providence Portland Medical Center
Portland, Oregon, 97213
Kaiser Permanente Oncology/Hematology
Portland, Oregon, 97227
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Urology San Antonio Research, PA
San Antonio, Texas, 78229
San Bernardino Urology Associates
San Bernardino, California, 92404
Kaiser Permanente Medical Group Dept. of Oncology Research
San Diego, California, 92120
Sharp Healthcare
San Diego, California, 92123
California Pacific Medical Center
San Francisco, California, 94115
UCSF Mt. Zion Cancer Center
San Francisco, California, 94115
Seattle Cancer Care Alliance, Univ. of Washington
Seattle, Washington, 98109
Cancer Research & Prevention Center
Soquel, California, 95073

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France15 sites

Centre Regional de lutte contre le cancer Paul Papin
Angers, 49033
Centre Francois Baclesse
Caen, 14076
Institut Jean Godinot, Oncologie Medicale
Cedex, 51056
Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne
Clermont-Ferrand, 63011
Centre Rene Gauducheau - Site Hospitalier Nord
Nantes, 44805
Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer
Nice, 06189
CHU Saint Louis
Paris, 75010
Hopital Saint Joseph Site Saint Michel
Paris, 75015
Hopital Cochin
Paris, 75674
CHU Poitiers
Poitiers, 86021
Centre Hospitalier Rene Dubos
Pontoise, 95303
Clinique Armoricaine de Radiology
Saint-Brieuc, 22015
Hopital Civil
Strasbourg, 67091
CHU Bretonneau
Tours, 37044
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54500

Other trials in France

United Kingdom13 sites

Addenbrookes Hospital
Cambridge, CB2 2QQ
Royal Surrey County Hospital
Guildford, GU2 7XX
St. James University Hospital
Leeds, LS9 7TF
Lincoln County Hospital
Lincoln, LN2 4AX
Royal Marsden Hospital
London, SW3 6JJ
Department of Oncology Hammersmith Hospital
London, W12 0NN
Christie Hospital Manchester
Manchester, M20 4BX
Clatterbridge Centre For Oncology
Metropolitan Borough of Wirral, CH63 4JY
Mount Vernon Hospital
Middlesex, HA6 2RN
Nottingham City Hospital
Nottingham, NG5 1PB
Rosemere Cancer Centre, Royal Preston Hospital
Preston, PR2 9HT
Scunthorpe General Hospital, Dept of Oncology
Scunthorpe, DN15 7BH
Royal Marsden Academic Urology Unit
Sutton, SM2 5PT

Other trials in United Kingdom

Italy11 sites

Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, 20122
Fondazione San Raffaele del Monte Tabor
Milan, 20132
Istituto Europeo di Oncologia
Milan, 20141
Istituto Nazionale dei Tumori
Milan, 20133
Azienda Ospedaliero Universitaria di Modena
Modena, 41100
Azienda Ospedaliera Maggiore della Carita
Novarra, 28100
Azienda Ospedaliera di Parma
Parma, 43100
Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara
Pisa, 56126
Azienda Ospedaliera San Camillo Forlanini
Roma, 00152
Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata
Sassari, 07100
A.S.O. San Giovanni Battista di Torino
Turin, 10126

Other trials in Italy

Poland11 sites

Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bialystok, 15-950
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Bytom, 41-902
Katedra i Klinika Onkologii i Radioterapli
Gdansk, 80-952
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Katowice, 40-073
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Krakowie
Krakow, 31-115
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
Lodz, 93-509
Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu
Poznan, 61-848
Wojewodzki Szpital Specjalistyczny w Siedlcach
Siedlce, 08-110
Wojewodzki Szpital Specjalistyczny Oddzial Urologii
Słupsk, 76-200
Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen
Warsaw, 02-005
Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie
Warsaw, 02-781

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Germany8 sites

Universitatsklinikum Aachen
Aachen, 52074
Charite Campus Mitte
Berlin, 10117
Krankenhaus Am Urban
Berlin, 10967
Universitatsklinikum Carl Gustav Carus An Der
Dresden, 01307
Klinikum der Johann Wolfgang Goethe-Universitat
Frankfurt am Main, 60590
Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz
Mainz, 55131
Klinikum Mannheim
Mannheim, 68135
Urologische Klinik und Poliklinik
München, 81675

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Belgium6 sites

Ziekenhuis Netwerk Antwerpen - AZ Middelheim
Antwerp, B-2020
V.Z.W. Imelda Ziekenhuis
Bonheiden, B-2820
AZ Groeninge
Kortrijk, B-8500
CHU de Liège - Hôpital du Sart Tilman
Liège, B-4000
Heilig-Hartziekenhuis Campus Wilgenstraat
Roeselare, B- 8800
Regionaal Ziekenhuis Sint Trudo
Sint-Truiden, B-3800

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Netherlands3 sites

VU Medisch Centrum
Amsterdam, 1081 HV
Academisch Centrum
Amsterdam, 1105 AZ
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ

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Sweden3 sites

Universitetssjukhuset i Lund
Lund, SE-22185
University Hospital MAS (UMAS)
Malmö, SE-205 02
Akademiska Sjukhuset i Uppsala
Uppsala, SE-75185

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Canada2 sites

Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, H2L 4M1
Centre Hospitalier Universite de Sherbrooke
Sherbrooke, Quebec, J1H 5N4

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About this study

Official title: A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

Conditions: Prostate Cancer
Being tested: Immunotherapy allogeneic GM-CSF secreting cellular vaccine, Chemotherapy (docetaxel and prednisone)
Keywords: Advanced Prostate Cancer, HRPC, Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy, Taxotere, Docetaxel, Prednisone, Vaccine, Allogeneic cells
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 allogeneic GM-CSF secreting cellular vaccineBiological
Immunotherapy allogeneic GM-CSF secreting cellular vaccine
Chemotherapy (docetaxel and prednisone)Drug
Chemotherapy (docetaxel and prednisone)

Study groups in NCT00133224
Study group	Role	What they receive
1	Experimental	Not described Receives: Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
2	Other	Not described Receives: Drug: Chemotherapy (docetaxel and prednisone)

What is being measured

The primary outcome is the main question the study is designed to answer.

Survival
Measured: 0

Secondary outcomes (1)

Time to disease progression. Time to pain progression.
Measured: 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Jun 2009

First posted23 Aug 2005 (estimated)
Study startJul 2005
Primary completionAug 2008
Study completionJun 2009 (estimated)

Why it stopped: Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.

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: 408 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00133224
Sponsor's protocol ID: G-0034
Other IDs: VITAL-2
Status last verified: Sep 2008
First submitted: 19 Aug 2005
Last updated: 23 Sep 2008
Results posted: No

Publications

Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495.
PubMed 22736604

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
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All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain
ClinicalTrials.gov ID: NCT00133224
Acronym / sponsor ID: G-0034
Conditions: Prostate Cancer
Keywords: Advanced Prostate Cancer, HRPC, Prostate, Cancer, Metastatic, Hormone-refractory, GVAX, Chemotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.
Enrolment: 408 participants (actual)
Lead sponsor: Cell GenesysIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Aug 2008 (actual)
Study completion: Jun 2009 (estimated)
First posted: 23 Aug 2005 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: Immunotherapy allogeneic GM-CSF secreting cellular vaccine
2	Other	Drug: Chemotherapy (docetaxel and prednisone)

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 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
ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
Any Gleason score

Key exclusion criteria (0 listed)

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 allogeneic GM-CSF secreting cellular vaccineImmunotherapy allogeneic GM-CSF secreting cellular vaccine	Biological	1
Chemotherapy (docetaxel and prednisone)Chemotherapy (docetaxel and prednisone)	Drug	2

Primary outcome

Survival
Time frame: 0

1 secondary outcome

Time to disease progression. Time to pain progression.
Time frame: 0

Results and safety

The study was stopped early (reason given: Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2008.
Derived from this study: PubMed 22736604Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495.

Related trials for Prostate Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

115 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 0 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 23 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, France, United Kingdom, Italy, Poland and 5 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: Accrual and treatment with CG1940/CG8711 stopped due to IDMC recommendation.). 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 NCT00133224, 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 23 Sep 2008.