National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
Search
NCI Home Cancer Topics Clinical Trials Cancer Statistics Research & Funding News About NCI
Clinical Trials (PDQ®)
Patient VersionHealth Professional Version
Page Options
Print This Page  Print This Page
E-Mail This Document  E-Mail This Document
Quick Links
Director's Corner

Dictionary of Cancer Terms

NCI Drug Dictionary

Funding Opportunities

NCI Publications

Advisory Boards and Groups

NIH Calendar of Events

Español
NCI Highlights
Imiquimod May Help to Prevent Vulvar Cancer

Sorafenib Increases Risk of High Blood Pressure

Past Highlights
HPV Vaccines for Cervical Cancer
BreastCancerTrials.org
Docetaxel in Combination With GVAX ® Immunotherapy Versus Docetaxel and Prednisone in Prostate Cancer Patients

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase III


Treatment


Active


18 and over


Pharmaceutical / Industry


G-0034
VITAL-2, NCT00133224

Trial Description

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 documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

As this is a survival trial and it is difficult to predict when deaths or the primary/secondary endpoints will occur, the anticipated completion dates provided represent the estimated completion of accrual, and the timeframes for the primary/secondary endpoints cannot be accurately estimated.

Eligibility Criteria

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
  • ECOG performance status ≤2 (Performance status of 3 if due to bone pain)
  • Any Gleason score
  • Only one prior treatment with systemic chemotherapy
  • No prior treatment with gene therapy
  • No prior immunotherapy for prostate cancer
  • Taxane naïve
  • Experiencing cancer-related pain

Trial Contact Information

Trial Lead Organizations/Sponsors

Cell Genesys, Incorporated

Trial Sites

U.S.A.
Alaska
  Anchorage
 Alaska Clinical Research Center, LLC
 Mary Anderson Ph: 907-276-1455
  Email: marya@akurologlical.com
 Kevin M Tomera, MD Ph: 907-276-1455
  Email: ktomera@alaska.net
 Kevin M Tomera, MDPrincipal Investigator
Arkansas
  Fort Smith
 St. Edward Mercy Medical Center
 Debbie Martin, RN Ph: 479-314-5089
  Email: dmartin@ftsm.mercy.net
 Daniel Mackey, MD Ph: 479-314-5089
  Email: dmartin@ftsm.mercy.net
 Daniel Mackey, MDPrincipal Investigator
California
  Loma Linda
 Loma Linda University Cancer Institute at Loma Linda University Medical Center
 Janet Byrd Ph: 909-558-3375
  Email: jbyrd@llu.edu
 Chein-Shing Chen, MD Ph: 909-558-3375
  Email: jbyrd@llu.edu
 Michael Lilly, MDPrincipal Investigator
  Los Angeles
 Onocology Care Medical Associates
 Inga Kirakosian Ph: 213-989-1888
 Ira Felman, MD Ph: 323-726-7535
  Email: ifelman@sbcglobal.net
 Ira Felman, MDPrincipal Investigator
  Rancho Mirage
 Desert Hematology-Oncology Medical Group, Incorporated
 Nikkol A. Villarroel, CRC Ph: 760-568-3613
  Email: nikkolvillaroel@dc.rr.com
 Luke P. Dreisbach, MD Ph: 760-568-3613
  Email: crdreis@aol.com
 Luke P. Dreisbach, MDPrincipal Investigator
  San Bernardino
 San Bernardino Urological Associates Medical Group
 Charity Hernandez Ph: 909-882-2973
  Email: charity@sburology.com
 Franklin M Chu, MD Ph: 909-882-2973
  Email: FMCSBU@aol.com
 Franklin Chu, MDPrincipal Investigator
  San Diego
 Kaiser Permanente Medical Center - Kaiser Foundation Hospital - San Diego
 Sharon Cory Ph: 619-641-4689
 Jonathan Polikoff, MD Ph: 619-528-5170
  Email: jonathan.a.polikoff@kp.org
 Jonathan Polikoff, MDPrincipal Investigator
 Sharp Memorial Hospital Cancer Center
 Cathy Wood Ph: 858-939-5062
  Email: cathy.wood@sharp.com
 Charles Redfern, MD Ph: 858-637-7888
  Email: chredfern@yahoo.com
 Charles Redfern, MDPrincipal Investigator
  San Francisco
 California Pacific Medical Center - Pacific Campus
 Leslie Lee Ph: 415-600-1109
  Email: taylorLL@cpmcri.org
 Ari Baron, M.D. Ph: 415-923-3012
  Email: abaron@phoamd.com
 Ari Baron, M.D.Principal Investigator
 UCSF Helen Diller Family Comprehensive Cancer Center
 Sarah Dunlap Ph: 415-353-7418
 Eric Small, M.D. Ph: 415-353-7171
  Email: smalle@medicine.ucsf.edu
 Eric Small, M.D.Principal Investigator
  Soquel
 Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital
 Cecilia Rivas Ph: 831-462-8750
  Email: cecy@cybercancer.com
 J. Talisman Pomeroy, MD Ph: 831-462-8750
  Email: drtal@cybercancer.com
 J. Talisman Pomeroy, MDPrincipal Investigator
Colorado
  Aurora
 Cancer Center and Department of Medicine
 Jennie Areson Ph: 728-848-0696
  Email: jennie.areson@uchsc.edu
 Michael L. Glode, MD Ph: 720-848-0184
  Email: mike.glode@uchsc.edu
 Michael L. Glode, MDPrincipal Investigator
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Michelle Arnold Ph: 904-953-6174
 Winston Tan, MD Ph: 904-953-7290
 Winston Tan, MDPrincipal Investigator
  Jupiter
 Jupiter Hematology and Oncology Associates
 Janet Martin Ph: 561-745-5768
  Email: JMartin@jupitermed.com
 Henry J Shapiro, MD Ph: 561-745-5768
  Email: JMartin@jupitermed.com
 Henry J Shapiro, MDPrincipal Investigator
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Robin Stewart Ph: 863-904-1877
  Email: robin.stewart@lrmc.com
 Byron Hodge, MD Ph: 863-904-1900
  Email: byron.hodge@lrmc.com
 Byron Hodge, MDPrincipal Investigator
  Port St. Lucie
 Hematology Oncology Associates of the Treasure Coast - Port St. Lucie
 Christine Baker-Gerdes Ph: 772-408-5159
  Email: cgerdes@hemoncfl.com
 Michael Wertheim, MD Ph: 772-335-5666
  Email: cgerdes@hemoncfl.com
 Michael Wertheim, MDPrincipal Investigator
Georgia
  Atlanta
 Peachtree Hematology and Oncology Consultants, PC
 Polly Searcy Ph: 678-298-3238
 Charles A Henderson, MD Ph: 404-350-9853
 Charles A. Henderson, MDPrincipal Investigator
 Veterans Affairs Medical Center - Atlanta (Decatur)
 Perry McDaniel Ph: 404-728-7680
  Email: perry.mcdaniel@va.gov
 Wayne B Harris, MD Ph: 404-778-1900
  Email: wayne.harris@va.gov
 Wayne B Harris, MDPrincipal Investigator
 Winship Cancer Institute of Emory University
 Courtney Johnson Ph: 404-778-5144
  Email: courtney.johnson@emoryhealthcare.org
 Wayne B Harris, MD Ph: 404-728-7680
 Wayne Harris, MDPrincipal Investigator
Illinois
  Galesburg
 Medical & Surgical Specialists
 Gina Riner Ph: 309-343-2262
 John McClean, MD Ph: 309-343-2262
 John McClean, MDPrincipal Investigator
Maryland
  Frederick
 Frederick Memorial Hospital Regional Cancer Therapy Center
 Shelley Francella Ph: 301-668-7043
  Email: sfrancella@fmh.org
 Gregory Rausch, MD Ph: 301-662-8477
  Email: pgrausch@fmh.org
 Gregory Rausch, MDPrincipal Investigator
Michigan
  Ann Arbor
 General Clinical Research Center - Ann Arbor
 Tammy Huebner Ph: 734-764-2248
 David C. Smith, MD Ph: 734-764-2248
  Email: dcsmith@umich.edu
 David C Smith, MDPrincipal Investigator
Montana
  Billings
 Billings Clinic Cancer Center
 Kathy Wilkinson Ph: 406-238-2866
  Email: kwilkinson@billingsclinic.org
 William T. Purcell, MD Ph: 406-238-2690
  Email: wpurcell@billingsclinic.org
 William T. Purcell, MDPrincipal Investigator
Nebraska
  Omaha
 Hematology/Oncology Consultants
 Amy Peterson Ph: 402-572-3511
 James R Commers, MD Ph: 402-572-3535
 James R Commers, MDPrincipal Investigator
 UNMC Eppley Cancer Center at the University of Nebraska Medical Center
 Terry Burke Ph: 402-559-8649
  Email: tburke@unmc.edu
 Ralph Hauke, MD Ph: 402-559-6210
  Email: rhauke@unmc.edu
 Ralph Hauke, MDPrincipal Investigator
Nevada
  Las Vegas
 Nevada Cancer Institute
 Carol Varela, CRA, CCRC Ph: 702-822-5449
  Email: cvarela@nvcancer.org
 Bryan Wong, MD Ph: 702-822-5433
  Email: bwong@nvcancer.org
 Bryan Wong, MDPrincipal Investigator
New Jersey
  Hackensack
 Hackensack University Medical Center Cancer Center
 Kevin Barga Ph: 201-336-8017
 Robert Alter, M.D. Ph: 201-996-5900
 Robert Alter, M.D.Principal Investigator
New Mexico
  Albuquerque
 New Mexico Cancer Center
 Kristin Berg Ph: 505-243-4039
  Email: kristinb@nmohc.com
 James Liebmann, MD Ph: 505-842-8171
  Email: tinab@nmohc.com
 James Liebmann, MDPrincipal Investigator
New York
  East Setauket
 North Shore Hematology/Oncology Associates, PC
 Joann Messina Ph: 631-751-3000
  Email: jmessina@nshoa.com
 Evan R Berger, MD Ph: 631-751-3000
  Email: sgoldber@nshoa.com
 Evan R Berger, MDPrincipal Investigator
  New York
 NYU Cancer Institute at New York University Medical Center
 Denise Rodriguez Ph: 212-263-3712
  Email: denise.rodriguez@med.nyu.edu
 Anna Ferrari, MD Ph: 212-731-5389
  Email: anna.ferrari@nyumc.org
 Anna Ferrari, MDPrincipal Investigator
North Carolina
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Phyllis Cooper Ph: 704-316-4185
  Email: prcooper@novanthealth.org
 Richard Reiling, MD Ph: 704-384-9955
  Email: rbreiling@novanthealth.org
 Richard Reiling, MDPrincipal Investigator
North Dakota
  Bismarck
 Bismarck Cancer Center
 Shari Sanders Ph: 701-250-8420
 Mathew R Thomas, MD Ph: 701-530-6068
  Email: mrthomas@primecare.org
 M R Thomas, MDPrincipal Investigator
Ohio
  Canton
 Gabrail Cancer Center - Canton Office
 Carrie Smith Ph: 330-492-3345 Ext.208
  Email: csmith@gabrailcancercenter.com
 Nashat Gabrail, MD Ph: 330-492-3345 Ext.208
  Email: ngabrailmd@aol.com
 Nashat Gabrail, MDPrincipal Investigator
Oregon
  Portland
 Kaiser Permanente Medical Office - Interstate Medical Office Central
 Heather Houston Ph: 503-249-3506
  Email: heather.houston@kpchr.org
 Mark U. Rarick, MD Ph: 503-249-3510
  Email: mark.u.rarick@kpchr.org
 Mark U. Rarick, MDPrincipal Investigator
 Providence Cancer Center at Providence Portland Medical Center
 Theresa Ratzow Ph: 503-215-2604
  Email: theresa.ratzow@providence.org
 Brendon Curti, MD Ph: 503-215-5696
  Email: brendancurti@providence.org
 Brendon Curti, MDPrincipal Investigator
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Eastside
 Lisa Johnson Ph: 864-679-3966
  Email: lisa.johnson@usoncology.com
 Joe Stephenson Ph: 864-0679-3966
  Email: joe.stephenson@usoncology.com
 Joe StephensonPrincipal Investigator
Tennessee
  Memphis
 West Clinic - East Memphis
 Tracy Stewart Ph: 901-683-0055
  Email: tstewart@westclinic.com
 Bradley Somer, MD Ph: 901-683-0055
  Email: bsomer@westclinic.com
 Bradley Somer, MDPrincipal Investigator
Texas
  Dallas
 Dallas Oncology Consultants, PA - West Wheatland
 Edward L Middleman, MD Ph: 972-283-2389
  Email: middlemane@dallasoncologyconsultants.com
 Edward L Middleman, MDPrincipal Investigator
 Medical City Dallas Hospital
 Cathy Teel Ph: 972-566-8153
 Barry Mirtsching, MD Ph: 972-566-5588
  Email: bmirtsching@cortpa.com
 Barry Mirtsching, MDPrincipal Investigator
  Houston
 Mobley Research Center
 Debbie Era Ph: 713-357-0554
  Email: debbie@drmobley.com
 David Mobley, M.D. Ph: 713-357-0557
 David Mobley, M.D.Principal Investigator
 Northwest Cancer Center
 John Waldron, CCRP Ph: 713-541-1177
  Email: JWaldron@primestaffusa.com
 Laurent Gressot, MD Ph: 281-440-5060
  Email: Oncology@primestaffusa.com
 Laurent Gressot, MDPrincipal Investigator
  San Antonio
 Urology San Antonio, PA - Fredericksburg
 Alex Amaya Ph: 210-617-4116 Ext.1618
  Email: alex.amayo@urologysareserach.com
 Daniel Saltzstein, MD Ph: 210-617-4116
 Daniel R. SaltzsteinPrincipal Investigator
Washington
  Seattle
 Seattle Cancer Care Alliance
 Karlee Birt Ph: 206-288-1349
  Email: kso@u.washington.edu
 Celestia Higano, MD Ph: 206-288-1152
 Celestia Higano, MDPrincipal Investigator
Belgium
  Antwerpen
 Ziekenhuis Netwerk Antwerpen Middelheim
 Anita Boumans Ph: 3232803400
 Dirk Schrijvers, MD Ph: 3232804029
 Dirk Schrijvers, MDPrincipal Investigator
  Bonheiden
 V.Z.W. Imelda Ziekenhuis
 Wim Wynendaele Ph: 32 15 505 157
  Email: wim.wynendaele@imelda.be
 Wim Wynendaele Ph: 32 15 505 157
  Email: wim.wynendaele@imelda.be
 Wim Wynendaele