Spots Global Cancer Trial Database for Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
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Trial Identification
Brief Title: Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
Official Title: An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
Study ID: NCT00901342
Conditions
Interventions
Study Description
Brief Summary: This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
Detailed Description: Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Georgetown University Medical Center, Washington, D.C., District of Columbia, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Oncology Specialists, S.C., Park Ridge, Illinois, United States
Indiana University Department of Urology, Indianapolis, Indiana, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
Hematology Oncology Consultants, Greenbelt, Maryland, United States
Myron I. Murdock MD LLC, Greenbelt, Maryland, United States
John Theurer Cancer Center at Hackensack, Hackensack, New Jersey, United States
NYU Cancer Institute, New York, New York, United States
Mount Sinai School of Medicine Department of Urology, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
GU Oncology Research Program, Durham, North Carolina, United States
Oncology Hematology Care, Inc., Cincinnati, Ohio, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology, PA - Sammons Cancer Center, Dallas, Texas, United States
Urology of Virginia, PLLC, Virginia Beach, Virginia, United States
Virginia Mason Medical Center Urology and Renal Transplantation, Seattle, Washington, United States
Aurora Advanced Healthcare, Inc, Wauwatosa, Wisconsin, United States
Contact Details
Name: Robert Israel, MD
Affiliation: Valeant Pharmaceuticals North America LLC
Role: STUDY_DIRECTOR
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