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GVAX® Prostate Cancer Vaccine vs Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer - Article


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General Topics A-Z

Prostate Diseases

Benign Prostatic Hypertrophy; Prostate Disease; Prostate Enlargement; Prostatitis

Clinical Trial: GVAX® Prostate Cancer Vaccine vs Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer

This study is currently recruiting patients.

Sponsored by: Cell Genesys
Information provided by: Cell Genesys

Purpose

The purpose of this study is to compare the duration of survival between GVAX® prostate cancer vaccine 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 Treatment or Intervention Phase
Prostate Cancer
  Vaccine: Immunotherapy with allogeneic prostate vaccine
 Drug: Chemotherapy (Taxotere and prednisone)
 Phase III

MedlinePlus related topics:  Prostate Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further Study Details: 

Expected Total Enrollment:  600

Study start: July 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain

Location and Contact Information

MEDFONE Call Center      1-866-679-4904 

Alabama
      Central Alabama Oncology, LLC, Alabaster,  Alabama,  35007,  United States; Recruiting
Betty Veitch, RN  205-824-3635 
Elizabeth A. Lowenthal, DO  205-664-4051 
Elizabeth A. Lowenthal, DO,  Principal Investigator

Arizona
      Palo Verde Hematology/Oncology, Glendale,  Arizona,  85304,  United States; Recruiting
Gera Barnard  602-978-6255  Ext. 39 
Amol Rakkar, MD  602-978-6255 
Amol Rakkar, MD,  Principal Investigator

California
      Providence St-Joseph Medical Center, Burbank,  California,  91505,  United States; Recruiting
Ernesto Valdiri  818-847-3222 
Raul Mena, MD  818-840-0921 
Raul Mena, MD,  Principal Investigator

      Sharp Healthcare, San Diego,  California,  92123,  United States; Recruiting
Cathy Wood  858-939-5062 
Charles Redfern, M.D.  858- 637-7888 
Charles Redfern, M.D.,  Principal Investigator

      Compassionate Cancer Care Medical Group, Inc., Fountain Valley/Corona,  California,  92708,  United States; Recruiting
Lorrayne Skeens (Fountain Valley)  714-210-2300 
Mary Nashed (Corona)  951-371-2411 
Haresh S Jhangiani, MD,  Principal Investigator

      Cancer & Blood Institute Medical Group at the Lucy Curci Cancer Center, Rancho Mirage,  California,  92270,  United States; Recruiting
Susan Sagle  760-568-4461 
Robert Lemon, MD  760-568-4461 
Robert Lemon, MD,  Principal Investigator

      Orange County Regional Cancer Center, Fountain Valley,  California,  92708,  United States; Recruiting
Debbie Fridman  714-751-2600  Ext. 342 
Terry Sprague  714-751-2600 
Glen R Justice, MD,  Principal Investigator

      Cancer Research & Treatment Center, Soquel,  California,  95073,  United States; Recruiting
Michelle Steiny, NP  831-462-8750 
J. Talisman Pomeroy IV, MD  831-462-8750 
J. Talisman Pomeroy IV, MD,  Principal Investigator

      California Cancer Care, Greenbrae,  California,  94904,  United States; Recruiting
Jaime Chang  415-925-5040 
Peter D. Eisenberg, MD  415-925-5000 
Peter D. Eisenberg, MD,  Principal Investigator

      Kenmar Research Institute, LLC, Los Angeles,  California,  90057,  United States; Recruiting
Viet Pham  213-989-1888 
Mayank Vakil, MD  213-484-6474 
Mayank Vakil, MD,  Principal Investigator

      San Diego Cancer Center, Vista,  California,  92081,  United States; Recruiting
Dawn Billingsley  760-598-1700 
Alberto Bessudo  760-598-1700 
Alberto Bessudo, MD,  Principal Investigator

Colorado
      Cancer Center of Colorado Springs, Colorado Springs,  Colorado,  80907,  United States; Recruiting
Kaye Whitt, RN, OCN  719-444-4807 
Daniel Tell, MD  719-444-4807 
Daniel Tell, MD,  Principal Investigator

Connecticut
      Urology Center of Grove Hill, New Britain,  Connecticut,  06052-1395,  United States; Recruiting
Suzanne Collins  860-826-4453 
Rafael Wurzel, MD  860-826-4453 
Rafael Wurzel, MD,  Principal Investigator

Florida
      Oncology-Hematology Group of South Florida, Miami,  Florida,  33176,  United States; Recruiting
Julie Reed  305-728-1882 
Leonard Kalman, MD  305-595-2141 
Leonard Kalman, MD,  Principal Investigator

      Cancer Centers of Florida, Ocoee,  Florida,  34711,  United States; Recruiting
Lynne Hogue  407-658-9532 
Barry Berman, MD  407-297-6435 
Barry Berman, MD,  Principal Investigator

      Pasco Hernando Oncology, New Port Richey,  Florida,  34652,  United States; Recruiting
Eve Crosariol, RN  727-842-2795 
Kapisthalam Kumar, MD  727-842-2795 
Kapisthalam Kumar, MD,  Principal Investigator

      Tampa Bay Urology, Tampa,  Florida,  33607,  United States; Recruiting
Linda Haynie  813-872-7881 
Mark Swierzewski, MD  813-875-5855 
Mark Swierzewski, MD,  Principal Investigator

      Hematology Oncology Associates of the Treasure Coast, Port St. Lucie,  Florida,  34952,  United States; Recruiting
Christine Baker  772-408-5159 
Michael Wertheim, MD  772-335-5666 
Michael Wertheim, MD,  Principal Investigator

      Urology Consultants, Clearwater,  Florida,  33761,  United States; Recruiting
Phyllis Wattleworth  727-797-3281 
Mark Zachary, MD  727-724-9551 
James M Zachary, MD,  Principal Investigator

      Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital, Fort Lauderdale,  Florida,  33308,  United States; Recruiting
Carol Brudenell  954-267-7704 
Melanie White  954-267-7705 
Leonard Seigel, MD,  Principal Investigator

      The Center for Hematology-Oncology, Boca Raton,  Florida,  33486,  United States; Recruiting
Dolores Preiser, RN, OCN  561-416-8869  Ext. 262 
Alan Koletsky, MD  561-416-8869  Ext. 262 
Alan Koletsky, MD,  Principal Investigator

Georgia
      Central Georgia Hematology & Oncology Associates, P.C., Macon,  Georgia,  31201,  United States; Recruiting
Joanne Kerr  478-743-7068 
Frederick Schnell, M.D.  478-743-7068 
Frederick Schnell, M.D.,  Principal Investigator

      Georgia Cancer Specialists, Atlanta,  Georgia,  30342,  United States; Recruiting
Mary Jane Waddell, RN  770-496-9428 
Mansoor Saleh, MD  770-496-9403 
Mansoor Saleh, MD,  Principal Investigator

Hawaii
      Straub Clinic & Hospital, Honolulu,  Hawaii,  96813,  United States; Recruiting
Heather Bennett  808-547-5922 
Mary Kessel  808-547-5921 
Ian Okazaki, MD,  Principal Investigator

Idaho
      North Idaho Cancer Center, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Carla Taylor  208-666-3800 
Haluk Tezcan, MD  208-666-3800 
Haluk Tezcan, MD,  Principal Investigator

Illinois
      Midwest Cancer Research Group, Skokie,  Illinois,  60077,  United States; Recruiting
Sharon Goldman  847-673-1999 
Ira Oliff, MD  847-673-1999 
Ira Oliff, MD,  Principal Investigator

Indiana
      Welborn Clinic Research Center, Evansville,  Indiana,  47713,  United States; Recruiting
Missy Goffinet  812-492-5011 
Paul Siami, MD  812-426-9275 
Paul Siami, MD,  Principal Investigator

      Fort Wayne Medical Oncology/Hematology Inc., Fort Wayne,  Indiana,  46815,  United States; Recruiting
Leslie Edgar Edgar, NP  260-484-9660  Ext. 230 
Charles Whalen, MD  260-484-8830 
Charles Whalen, MD,  Principal Investigator

Iowa
      Cedar Valley Medical Specialists, Waterloo,  Iowa,  50702,  United States; Recruiting
Kim Maxfield  319-272-2700 
Joginder Singh, MD  319-272-2700 
Joginder Singh, MD,  Principal Investigator

Louisiana
      Lake Charles Medical and Surgical Clinic, Lake Charles,  Louisiana,  70601,  United States; Recruiting
Myra Thomas  337-312-8205 
Mohammad Khan, M.D.  337-312-8204 
Mohammad Khan, M.D.,  Principal Investigator

      Louisiana Oncology Associates, Lafayette,  Louisiana,  70506,  United States; Recruiting
Nancy Lormand  337-235-7898 
David Rinaldi, MD  337-235-7898 
David Rinaldi, MD,  Principal Investigator

Maryland
      Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick,  Maryland,  21701,  United States; Recruiting
Patricia Shank  301-668-7043 
Gregory Rausch, MD  301-662-8477 
Gregory Rausch, MD,  Principal Investigator

Michigan
      William Beaumont Hospital, Cancer Clinical Trials Office, Royal Oak,  Michigan,  48073-6706,  United States; Recruiting
Ingrid Tibbits  248-551-6935 
David Decker, MD  248-551-6900 
David Decker, MD,  Principal Investigator

      West Michigan Regional Cancer and Blood Center, Free Soil,  Michigan,  49411,  United States; Recruiting
Joe Johnson  231-757-1260 
A. Soliman Behairy, MD  231-757-1260 
A. Soliman Behairy, MD,  Principal Investigator

      Newland Medical Associates, P.C., Southfield,  Michigan,  48075,  United States; Recruiting
Janine Haubenreich  248-552-0620 
Anibal Drelichman, MD  248-552-0620 
Anibal Drelichman, MD,  Principal Investigator

Missouri
      St. Joseph Oncology, Inc., St. Joseph,  Missouri,  64507,  United States; Recruiting
Bob Moore  816-271-1032 
Robert Weigand, MD  816-271-1301 
Robert Weigand, MD,  Principal Investigator

      Hematology Oncology Consultants, Inc., St. Louis,  Missouri,  63136,  United States; Recruiting
Helen Mullner  314-355-5597  Ext. 31 
Mark Woodson, MD  314-355-5597 
Mark Woodson, MD,  Principal Investigator

Montana
      Hematology/Oncology Centers of the Northern Rockies, P.C., Billings,  Montana,  59101,  United States; Recruiting
Celia Fisher  406-238-6962 
Patrick Cobb, MD  406-238-6290 
Patrick Cobb, MD,  Principal Investigator

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States; Recruiting
Rose Solberg  402-559-8649 
Ralph Hauke, MD  402-559-6210 
Ralph Hauke, MD,  Principal Investigator

New Hampshire
      Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States; Recruiting
Denise Machado-Rogers  603-650-7859 
Marc Ernstoff, MD  603-650-5534 
Marc Ernstoff, MD,  Principal Investigator

New Jersey
      Hematology-Oncology Associates of Northern New Jersey, Morristown,  New Jersey,  07962,  United States; Recruiting
Serena Schmitz  973-538-5210  Ext. 2338 
Stacey Leibowitz, MD  973-538-5210 
Stacey Leibowitz, MD,  Principal Investigator

      Summit Medical Group/Overlook Oncology Center, Summit,  New Jersey,  07901,  United States; Recruiting
Vanessa Shaw  908-273-4300  Ext. 5131 
Michael Wax, MD  908-219-3080 
Michael Wax, MD,  Principal Investigator

New York
      SUNY Upstate Medical University, Syracuse,  New York,  13210,  United States; Recruiting
Diane Gould  315-464-8235 
Bernard Poiesz, MD  315-464-5476 
Bernard Poiesz, MD,  Principal Investigator

      Jacobi Medical Center, Division of Hematology/Oncology, Bronx,  New York,  10461,  United States; Recruiting
Bola Omotosho  718-918-4581 
Manuel Macapinlac, MD  718-918-4581 
Manuel Macapinlac, MD,  Principal Investigator

North Carolina
      Northwestern Carolina Hematology Oncology, PA, Hickory,  North Carolina,  28602,  United States; Recruiting
Sylvia McLendon  828-324-9550  Ext. 222 
Richard Orlowski, MD  828-324-9550 
Richard Orlowski, MD,  Principal Investigator

      Presbyterian Hospital/ Center for Cancer Research, Charlotte,  North Carolina,  28233,  United States; Recruiting
Lori Lipocky, RN, OCN  704-384-8920 
Neil West, RN  704-384-9429 
Richard B. Reiling, MD,  Principal Investigator

North Dakota
      Dakota Cancer Institute, Fargo,  North Dakota,  58103,  United States; Recruiting
Pat Reiser  701-232-2388 
Kaushik Sen, MD  701-364-8910 
Kaushik Sen, MD,  Principal Investigator

Ohio
      Gabrail Cancer Center, Canton,  Ohio,  44718,  United States; Recruiting
Carrie Smith  330-492-3345  Ext. 208 
Nashat Gabrail, MD  330-492-3345 
Nashat Gabrail, MD,  Principal Investigator

Oregon
      Providence Portland Medical Center, Portland,  Oregon,  97213,  United States; Recruiting
Chrislyn DiNuova  503-215-6805 
Brendan Curti, MD  503-215-5696 
Brendan Curti, MD,  Principal Investigator

Pennsylvania
      Medical Oncology Associates, Kingston,  Pennsylvania,  18704,  United States; Recruiting
Angela Luongo  570-331-8105 
Bruce Saidman, MD  570-262-3894 
Bruce Saidman, MD,  Principal Investigator

      Urological Associates of Lancaster, Lancaster,  Pennsylvania,  17604,  United States; Recruiting
Dorie Rodriguez  717-431-2285 
Paul Sieber, MD  717-431-2285 
Paul Sieber, MD,  Principal Investigator

Rhode Island
      University Urological Research Institute, Providence,  Rhode Island,  02904,  United States; Recruiting
Jeanette Szaro, BSN, CCRP  401-272-7799  Ext. 1257 
Barry Stein, MD  401-272-7799 
Barry Stein, MD,  Principal Investigator

South Carolina
      Charleston Hematology Oncology, Charleston,  South Carolina,  29403,  United States; Recruiting
Deborah McNeal  843-577-6957 
George Geils, MD  843-577-6957 
George Geils, MD,  Principal Investigator

Tennessee
      The West Clinic, Memphis,  Tennessee,  38120,  United States; Recruiting
Sherry Hodges, RN  901-683-0055  Ext. 1049 
Brad Somer, ME  901-683-0055 
Brad Somer, MD,  Principal Investigator

      Memorial Health Care System, Chattanooga,  Tennessee,  37404,  United States; Recruiting
Suzanne Stephens  423-495-8975 
Penny Skelton  423-495-4775 
Edward R. Arrowsmith, MD,  Principal Investigator

      Mid-South Cancer Center, Memphis,  Tennessee,  38119,  United States; Recruiting
Jonathan Davis  901-763-0446 
Kirby Smith, MD  901-763-0446 
Kirby Smith, MD,  Principal Investigator

Texas
      The Methodist Hospital, Houston,  Texas,  77030,  United States; Recruiting
Pat Brinegar  713-363-7987 
Alejandro Preti, MD  713-795-0933 
Alejandro Preti, MD,  Principal Investigator

      Cancer Specialists of South Texas, Corpus Christi,  Texas,  78412,  United States; Recruiting
Katrina Powell  361-993-3456  Ext. 140 
Albert Wood, MD  361-993-3456 
Albert Wood, MD,  Principal Investigator

      Mary Crowley Medical Research Center, Dallas,  Texas,  75246,  United States; Recruiting
Candace Branom, RN  214-370-1857 
John Nemunaitis, MD  214-370-1870 
John Nemunaitis, MD,  Principal Investigator

      Tyler Cancer Center, Tyler,  Texas,  75702,  United States; Recruiting
Linda Dunklin, RN  903-579-9800 
Karen Poe, RN  903-579-9869 
Donald Richards, MD,  Principal Investigator

      Harrington Cancer Center, Amarillo,  Texas,  79106,  United States; Recruiting
Rose Ingerson, RN  806-354-5875  Ext. 231 
Leonard Forero, MD  806-354-5875 
Leonard Forero, MD,  Principal Investigator

      Urology Clinic of North Texas, Dallas,  Texas,  75231,  United States; Recruiting
Tracy Williams Reed  214-345-4121 
James S. Cochran, MD  214-691-1902 
James S. Cochran, MD,  Principal Investigator

Virginia
      Virginia Oncology Associates, Norfolk,  Virginia,  23502,  United States; Recruiting
Ora Mae Jackson, RN, OCN  757-459-9250 
Paul R Conkling, MD  757-873-9833 
Paul R Conkling, MD,  Principal Investigator

Washington
      Yakima Regional Cancer Care Center, Yakima,  Washington,  98902,  United States; Recruiting
Beth S Parker  509-225-2448 
William Von Stubbe  509-575-7671 
William Von Stubbe, MD,  Principal Investigator

      Virginia Mason Medical Center Urology, Seattle,  Washington,  98101,  United States; Recruiting
Kathryn Dahl  206-341-0578 
John Corman, MD  206-625-7373  Ext. 63348 
John Corman, MD,  Principal Investigator

More Information

Study ID Numbers:  G-0029; (VITAL-1)
Record last reviewed:  March 2005
Last Updated:  April 5, 2005
Record first received:  August 16, 2004
ClinicalTrials.gov Identifier:  NCT00089856
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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