Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

November 30, 1999

Primary Completion Date

September 30, 2004

Study Completion Date

September 30, 2004

Conditions
Prostate Cancer
Interventions
BIOLOGICAL

sipuleucel-T

Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.

BIOLOGICAL

Placebo

Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

Trial Locations (34)

10011

St. Vincents Comprehensive Cancer Center, New York

10016

NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York

10019

St. Luke's-Roosevelt Hospital, New York

10021

New York Presbyterian Hospital - Cornell Campus, New York

10461

Albert Einstein Comprehensive Cancer Center, The Bronx

10595

New York Medical College, Valhalla

11530

Center for Medical Oncology, Garden City

12208

Albany Regional Cancer Center, Albany

14642

University of Rochester Cancer Center, Rochester

18510

Hematology/Oncology Associates of NE Pennsylvania, P.C., Scranton

19001

Abington Hematology Oncology Associates, Incorporated, Abington

19010

Bryn Mawr Urology, Bryn Mawr

Office of Guy Bernstein, M.D., Bryn Mawr

19047

Saint Mary Regional Cancer Center, Langhorne

23507

Devine Tidewater Urology, Norfolk

32806

Office of Barry S. Berman, Orlando

43214

AKSM Clinical Research Corporation, Columbus

55905

Mayo Clinic Cancer Center, Rochester

75246

American Oncology Resources, Dallas

90601

Office of Glenn Tisman, Whittier

92121

Sidney Kimmel Cancer Center, San Diego

92270

Cancer and Blood Institute of the Desert, Rancho Mirage

Eisenhower Medical Center, Rancho Mirage

92354

Loma Linda University Medical Center, Loma Linda

98109

Seattle Cancer Care Alliance, Seattle

98405

Hematology Oncology Northwest, P.C., Tacoma

99202

Cancer Care Northwest, Spokane

91010-3000

Cancer Center and Beckman Research Institute, City of Hope, Duarte

94143-0128

UCSF Cancer Center and Cancer Research Institute, San Francisco

07601

Hackensack University Medical Center, Hackensack

07039

St. Barnabas Medical Center, Livingston

07962-1956

Morristown Memorial Hospital, Morristown

97213-2967

Earle A. Chiles Research Institute at Providence Portland Medical Center, Portland

19446-1200

North Penn Hospital, Lansdale

Sponsors

Lead Sponsor

All Listed Sponsors
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Dendreon

INDUSTRY

NCT00005947 - Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy | Biotech Hunter | Biotech Hunter