Clinical trial NCT00849290: Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Official title: AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Androgen Independent Prostate Cancer
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 113
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


Eligibility criteria: Inclusion Criteria:

* Objective disease progression
* Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Safety of APC8015F by Review of Reported Adverse Events
timeFrame: periodically over 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp HealthCare
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center
state: California
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Walter Reid Army Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Miami Cancer Center
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology/Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Georgia Urology, P.A.
state: Georgia
city: Chicago
country: United States
facility: Midwest Prostate & Urology Health Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Greenbelt
country: United States
facility: Myron I Murdock MD LLC
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic (Department of Urology)
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: West Orange
country: United States
facility: Associates in Urology, LLC
state: New Jersey
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: New York
country: United States
facility: Beth Israel Cancer Center
state: New York
city: New York
country: United States
facility: Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Staten Island
country: United States
facility: Staten Island Urological Research
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: EACRI
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Medical Group
state: Oregon
city: Bryn Mawr
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Medical College
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Urology of Virginia, PC
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Hospital Immunotherapy Program
state: Wisconsin
city: Victoria
country: Canada
facility: Can-Med Medical Research, Inc.
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College HSC
state: Ontario
city: Montreal
country: Canada
facility: Hospital Notre Dame du CHUM
state: Quebec
Study officials:
affiliation: Devine Tidewater Urology
name: Paul Schellhammer, MD
role: STUDY_CHAIR
References: