GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer
Sponsor
Cell Genesys (Industry)
Overall Status
Terminated
CT.gov ID
NCT00089856
Collaborator
(none)
626
126
2
51
5
0.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
626 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Jul 1, 2004
Actual Primary Completion Date
:
Oct 1, 2008
Actual Study Completion Date
:
Oct 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 2 Standard of care - chemotherapy |
Drug: Chemotherapy (Taxotere and prednisone)
Chemotherapy (Taxotere and prednisone)
|
| Experimental: 1 Immunotherapy |
Biological: Immunotherapy with allogeneic prostate vaccine
Immunotherapy with allogeneic prostate vaccine
|
Outcome Measures
Primary Outcome Measures
- Survival [0]
Secondary Outcome Measures
- Bone pain and bone related events [0]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Prior treatment with chemotherapy
-
Prior Immunotherapy
-
Prior treatment with gene therapy
-
Significant cancer related pain
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Alabama Oncology, LLC | Alabaster | Alabama | United States | 35007 |
| 2 | Alaska Clinical Research Center | Anchorage | Alaska | United States | 99508 |
| 3 | Palo Verde Hematology/Oncology | Glendale | Arizona | United States | 85304 |
| 4 | Mayo Clinic Scottsdale | Scottsdale | Arizona | United States | 85259 |
| 5 | ACRC/Arizona Clinical Res. Ctr. Inc. | Tuscon | Arizona | United States | 85715 |
| 6 | Arkansas Cancer Research Center | Little Rock | Arkansas | United States | 72205 |
| 7 | Compassionate Cancer Care Medical Group, Inc. | Corona | California | United States | 92882 |
| 8 | Pacific Coast Hem Onc. Medical Group | Fountain Valley | California | United States | 92708 |
| 9 | California Cancer Care | Greenbrae | California | United States | 94904 |
| 10 | Center for Urological Research | La Mesa | California | United States | 91942 |
| 11 | Oncology Care Medical Associates | Montebello | California | United States | 90640 |
| 12 | UC Irvine Medical Center | Orange | California | United States | 92868 |
| 13 | San Bernardino Urological Associates | San Bernardino | California | United States | 92404 |
| 14 | Sharp Healthcare | San Diego | California | United States | 92123 |
| 15 | California Pacific Medical Center | San Francisco | California | United States | 94115 |
| 16 | Cancer Research & Prevention Center | Soquel | California | United States | 95073 |
| 17 | San Diego Cancer Center | Vista | California | United States | 92081 |
| 18 | Univ. of Colorado Health Science Center | Aurora | Colorado | United States | 80045 |
| 19 | Cancer Center of Colorado Springs | Colorado Springs | Colorado | United States | 80907 |
| 20 | The Hope Clinic | Bristol | Connecticut | United States | 06010 |
| 21 | Urology Center of Grove Hill | New Britain | Connecticut | United States | 06052-1395 |
| 22 | Carl & Dorothy Bennett Cancer Center | Stamford | Connecticut | United States | 06902 |
| 23 | Boca Raton Community Hospital, Inc. | Boca Raton | Florida | United States | 33486 |
| 24 | Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital | Fort Lauderdale | Florida | United States | 33308 |
| 25 | Integrated Community Oncology Network | Jacksonville | Florida | United States | 32256 |
| 26 | Oncology-Hematology Group of South Florida/Advanced Medical Specialists | Miami | Florida | United States | 33176 |
| 27 | Cancer Centers of Florida | Ocoee | Florida | United States | 34761 |
| 28 | Hematology Oncology Associates of the Treasure Coast | Port St. Lucie | Florida | United States | 34952 |
| 29 | Urology Consultants | Safety Harbor | Florida | United States | 34695 |
| 30 | Atlanta VAMC | Atlanta | Georgia | United States | 30033 |
| 31 | Georgia Cancer Specialists | Atlanta | Georgia | United States | 30084 |
| 32 | Peachtree Hematology Oncology Consultants, PC | Atlanta | Georgia | United States | 30309 |
| 33 | Winship Cancer Institute, Emory University | Atlanta | Georgia | United States | 30322 |
| 34 | Central Georgia Cancer Care, P.C. | Macon | Georgia | United States | 31201 |
| 35 | Straub Clinic & Hospital | Honolulu | Hawaii | United States | 96813 |
| 36 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 37 | Welborn Clinic Research Center | Evansville | Indiana | United States | 47713 |
| 38 | Fort Wayne Medical Oncology/Hematology Inc. | Fort Wayne | Indiana | United States | 46815 |
| 39 | Louisiana Oncology Associates | Lafayette | Louisiana | United States | 70506 |
| 40 | Johns Hopkins University | Baltimore | Maryland | United States | 21231 |
| 41 | Frederick Memorial Hospital Regional Cancer Therapy Center | Frederick | Maryland | United States | 21701 |
| 42 | West Michigan Regional Cancer and Blood Center | Free Soil | Michigan | United States | 49411 |
| 43 | William Beaumont Hospital, Cancer Clinical Trials Office | Royal Oak | Michigan | United States | 48073-6706 |
| 44 | Newland Medical Associates, P.C. | Southfield | Michigan | United States | 48075 |
| 45 | Hematology Oncology Consultants, Inc. | St. Louis | Missouri | United States | 63136 |
| 46 | Deaconess Billings Clinic | Billings | Montana | United States | 59101 |
| 47 | Hematology/Oncology Centers of the Northern Rockies, P.C. | Billings | Montana | United States | 59101 |
| 48 | Omaha VA Medical Center | Omaha | Nebraska | United States | 68105 |
| 49 | Omaha VA Medical Center | Omaha | Nebraska | United States | 68198-7680 |
| 50 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 51 | The Center for Cancer & Hematologic Disease | Cherry Hill | New Jersey | United States | 08003 |
| 52 | Hematology-Oncology Associates of Northern New Jersey | Morristown | New Jersey | United States | 07962 |
| 53 | Summit Medical Group/Overlook Oncology Center | Summit | New Jersey | United States | 07901 |
| 54 | Jacobi Medical Center | Bronx | New York | United States | 10461 |
| 55 | Columbia University Medical Center | New York | New York | United States | 10032 |
| 56 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 57 | Presbyterian Hospital/ Center for Cancer Research | Charlotte | North Carolina | United States | 28204 |
| 58 | Northwestern Carolina Hematology Oncology, PA | Hickory | North Carolina | United States | 28602 |
| 59 | Medcenter One Cancer Care / Odyssey Research | Bismarck | North Dakota | United States | 58501 |
| 60 | Dakota Cancer Institute | Fargo | North Dakota | United States | 58103 |
| 61 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 62 | Cleveland Clinic Foundation, Taussig Cancer Center | Cleveland | Ohio | United States | 44195 |
| 63 | University of Oklahoma | Oklahoma City | Oklahoma | United States | 73104 |
| 64 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 65 | Urologic Surgery PC | Bala Cynwyd | Pennsylvania | United States | 19004 |
| 66 | Medical Oncology Associates | Kingston | Pennsylvania | United States | 18704 |
| 67 | Lancaster Cancer Center, Ltd | Lancaster | Pennsylvania | United States | 17601 |
| 68 | Urological Associates of Lancaster | Lancaster | Pennsylvania | United States | 17604 |
| 69 | University of Pittsburgh Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 70 | Charleston Hematology Oncology | Charleston | South Carolina | United States | 29403 |
| 71 | Memorial Health Care System | Chattanooga | Tennessee | United States | 37404 |
| 72 | The West Clinic | Memphis | Tennessee | United States | 38120 |
| 73 | The Don and Sybil Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 74 | Mary Crowley Medical Research Center | Dallas | Texas | United States | 75201 |
| 75 | Center for Oncology Research and Treatment PA | Dallas | Texas | United States | 75230 |
| 76 | Urology Specialists and Associates, P.A. | Dallas | Texas | United States | 75231 |
| 77 | Mobley Research Center | Houston | Texas | United States | 77024 |
| 78 | Urology San Antonio | San Antonio | Texas | United States | 78229 |
| 79 | Tyler Cancer Center | Tyler | Texas | United States | 75702 |
| 80 | Southwestern Oncology Research Department | Bennington | Vermont | United States | 05201 |
| 81 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
| 82 | Virginia Mason Medical Center Urology | Seattle | Washington | United States | 98101 |
| 83 | Seattle Cancer Care Alliance | Seattle | Washington | United States | 98109 |
| 84 | ZNA Middelheim | Antwerp | Belgium | B-2020 | |
| 85 | Imelda Ziekenhuis | Bonheiden | Belgium | 2820 | |
| 86 | University Hospital Antwerp (UZA) | Edegem | Belgium | 2650 | |
| 87 | UZ Gent | Gent | Belgium | 9000 | |
| 88 | Unversity Hospial Gent | Gent | Belgium | B-9000 | |
| 89 | Virga Jesse Ziekenhuis | Hasselt | Belgium | B-3500 | |
| 90 | AZ Groeninge | Kortrijk | Belgium | B-8500 | |
| 91 | Heilig Hartziekenhuis Roeselare Men | Roeselare | Belgium | B-8800 | |
| 92 | Regionaal Ziekenhuis Sint Trudo | Sint-Truiden | Belgium | B-3800 | |
| 93 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 94 | CHUM Notre-Dam | Montreal | Quebec | Canada | H2L 4M1 |
| 95 | McGill University | Montreal | Quebec | Canada | H2W1S6 |
| 96 | Ultra Med Inc. | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 97 | Centre Hopitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 98 | Centre Paul Papin | Angers Cedex | France | 49033 | |
| 99 | Centre Francois Baclesse | Caen Cedex 5 | France | 14076 | |
| 100 | Centre Georges Francois Leclerc | Dijon Cedex | France | 77980 | |
| 101 | Centre Leon Berard Service de Cancerologie Medicale | Lyon Cedex | France | 08 | |
| 102 | Institut Paoli-Calmettes | Marseille | France | 13009 | |
| 103 | Centre Rene Gauducheau | Nantes-Saint Herblain | France | 44805 | |
| 104 | Institut Jean Godinot | Reims Cedex | France | 51056 | |
| 105 | Centre Alexis Vautrin | Vandoeuvre les Nancy Cedex | France | 54511 | |
| 106 | Universitatsklinikum Aachen Urologie | Aachen | Germany | 52074 | |
| 107 | der Technischen Universitat Dresden | Dresden | Germany | 1307 | |
| 108 | Universitatsklinik um Essen | Essen | Germany | 45122 | |
| 109 | Universitatsklinik um des Saarlande | Homburg/Saar | Germany | 66421 | |
| 110 | VU Medisch Centrum | Amsterdam | Netherlands | 1081 HV | |
| 111 | University Medical Centre Groningen | Groningen | Netherlands | ||
| 112 | University Hospital, Linkoping | Linkoping | Sweden | ||
| 113 | University Hospital Lund | Lund | Sweden | ||
| 114 | Akademiska University Hospital | Uppsala | Sweden | 85 | |
| 115 | Addenbrooke's Hospital | Cambridge | United Kingdom | CB2 2QQ | |
| 116 | Beatson Oncology Centre | Glasgow | United Kingdom | G11 6NT | |
| 117 | St. James's University Hospital | Leeds | United Kingdom | LS97TF | |
| 118 | Hammersmith Hospital | London | United Kingdom | W12 0NN | |
| 119 | Mount Vernon Hospital | Middlesex | United Kingdom | HA6 2RN | |
| 120 | Newcastle General Hospital | Newcastle upon Tyne | United Kingdom | NE4 6BE | |
| 121 | Northampton General Hosptial | Northampton | United Kingdom | NN1 5BD | |
| 122 | Nottingham City Hospital | Nottingham | United Kingdom | NG5 1PB | |
| 123 | Oxford Cancer Centre, Churchill Hospital | Oxford | United Kingdom | OX3 7LT | |
| 124 | Scunthorpe General Hospital | Scunthorpe | United Kingdom | DN15 7BH | |
| 125 | Royal Hallamshire Hospital | Sheffield | United Kingdom | S10 2JF | |
| 126 | Glan Clwyd Hospital | Wales | United Kingdom | LL18 5UJ |
Sponsors and Collaborators
- Cell Genesys
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00089856
Other Study ID Numbers:
- G-0029
- (VITAL-1)
First Posted:
Aug 18, 2004
Last Update Posted:
Nov 5, 2008
Last Verified:
Nov 1, 2008
Keywords provided by ,
,
Additional relevant MeSH terms: