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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:


Location and Contact Information

MEDFONE Call Center      (when available) 

California
      Providence St-Joseph Medical Center, Burbank,  California,  91505,  United States; Recruiting
Evelyn Dizon  818-847-3218 
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

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

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
Patricia Deleon  407-297-6735 
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

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

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

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

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

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

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

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

      Piedmont Oncology Specialists, Charlotte,  North Carolina,  28207,  United States; Recruiting
Terri Brady  704-333-1555  Ext. 3# 
John Powderly, MD  704-549-3090 
John Powderly, 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

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, RN, BSN, CCRP  401-272-7799  Ext. 1257 
Barry Stein, MD  401-272-7799 
Barry Stein, MD,  Principal Investigator

Tennessee
      The West Clinic, Memphis,  Tennessee,  38120,  United States; Recruiting
Marnie Brotherton  901-683-0055  Ext. 1158 
Brad Somer, ME  901-683-0055 
Brad Somer, 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

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

More Information

Study ID Numbers:  G-0029; (VITAL-1)
Record last reviewed:  October 2004
Record first received:  August 16, 2004
ClinicalTrials.gov Identifier:  NCT00089856
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10
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