Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
- Conditions
- Metastatic Androgen Independent Prostate Cancer
- Interventions
- Biological: APC8015F
- Registration Number
- NCT00849290
- Lead Sponsor
- Dendreon
- Brief Summary
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 113
- Objective disease progression
- Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
- Infection requiring IV antibiotics
- Treatment with anticancer interventions within 14 days prior to enrollment
- Any medical condition which could compromise the study's objectives (discretion from sponsor)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description APC8015F APC8015F -
- Primary Outcome Measures
Name Time Method Safety of APC8015F by Review of Reported Adverse Events periodically over 24 months All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (57)
Georgia Urology, P.A.
πΊπΈAtlanta, Georgia, United States
Princess Margaret Hospital
π¨π¦Toronto, Ontario, Canada
Myron I Murdock MD LLC
πΊπΈGreenbelt, Maryland, United States
Staten Island Urological Research
πΊπΈStaten Island, New York, United States
Sunnybrook & Women's College HSC
π¨π¦Toronto, Ontario, Canada
Hematology/Oncology Associates of the Treasure Coast
πΊπΈPort Saint Lucie, Florida, United States
New York University
πΊπΈNew York, New York, United States
Lutheran General Cancer Center
πΊπΈPark Ridge, Illinois, United States
The Urological Institute of Northeastern New York
πΊπΈAlbany, New York, United States
Beth Israel Cancer Center
πΊπΈNew York, New York, United States
Urology of Virginia, PC
πΊπΈNorfolk, Virginia, United States
Cancer Care Northwest
πΊπΈSpokane, Washington, United States
London Health Sciences Centre
π¨π¦London, Ontario, Canada
Loyola University
πΊπΈMaywood, Illinois, United States
North Shore Hematology Oncology Associates
πΊπΈEast Setauket, New York, United States
McKay Urology
πΊπΈCharlotte, North Carolina, United States
Clinical Cancer Center
πΊπΈNew York, New York, United States
Mount Sinai School of Medicine
πΊπΈNew York, New York, United States
Jefferson Medical College
πΊπΈPhiladelphia, Pennsylvania, United States
Mary Crowley
πΊπΈDallas, Texas, United States
Miami Cancer Center
πΊπΈMiami, Florida, United States
Seattle Cancer Care Alliance
πΊπΈSeattle, Washington, United States
Virginia Mason Medical Center
πΊπΈSeattle, Washington, United States
UCLA
πΊπΈLos Angeles, California, United States
USC Keck School of Medicine
πΊπΈLos Angeles, California, United States
Midwest Prostate & Urology Health Center
πΊπΈChicago, Illinois, United States
Indiana University
πΊπΈIndianapolis, Indiana, United States
Albany Regional Cancer Center
πΊπΈAlbany, New York, United States
Cleveland Clinic Foundation
πΊπΈCleveland, Ohio, United States
Center for Urologic Care
πΊπΈBryn Mawr, Pennsylvania, United States
University of Wisconsin, Madison
πΊπΈMadison, Wisconsin, United States
Wenatchee Valley Medical Center
πΊπΈWenatchee, Washington, United States
Can-Med Medical Research, Inc.
π¨π¦Victoria, British Columbia, Canada
Hospital Notre Dame du CHUM
π¨π¦Montreal, Quebec, Canada
UCSF Cancer Center
πΊπΈSan Francisco, California, United States
University of Minnesota
πΊπΈMinneapolis, Minnesota, United States
Duke University Medical Center
πΊπΈDurham, North Carolina, United States
University of Utah
πΊπΈSalt Lake City, Utah, United States
Dana-Farber Cancer Institute
πΊπΈBoston, Massachusetts, United States
Lombardi Cancer Center
πΊπΈWashington, District of Columbia, United States
Grand Strand Urology
πΊπΈMyrtle Beach, South Carolina, United States
Nevada Cancer Institute
πΊπΈLas Vegas, Nevada, United States
Associates in Urology, LLC
πΊπΈWest Orange, New Jersey, United States
Lahey Clinic (Department of Urology)
πΊπΈBurlington, Massachusetts, United States
University of Cincinnati
πΊπΈCincinnati, Ohio, United States
Helen F. Graham Cancer Center
πΊπΈNewark, Delaware, United States
Walter Reid Army Medical Center
πΊπΈWashington, District of Columbia, United States
New York Medical College
πΊπΈHawthorne, New York, United States
Hackensack University Medical Center
πΊπΈHackensack, New Jersey, United States
University of Wisconsin
πΊπΈMadison, Wisconsin, United States
Baylor College of Medicine
πΊπΈHouston, Texas, United States
Sutter Cancer Center
πΊπΈSacramento, California, United States
Kaiser Permanente Medical Group
πΊπΈPortland, Oregon, United States
Mayo Clinic
πΊπΈRochester, Minnesota, United States
EACRI
πΊπΈPortland, Oregon, United States
St. Luke's Hospital Immunotherapy Program
πΊπΈMilwaukee, Wisconsin, United States
Sharp HealthCare
πΊπΈSan Diego, California, United States