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Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

Phase 2
Completed
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
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
APC8015FAPC8015F-
Primary Outcome Measures
NameTimeMethod
Safety of APC8015F by Review of Reported Adverse Eventsperiodically 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
NameTimeMethod

Trial Locations

Locations (57)

Georgia Urology, P.A.

πŸ‡ΊπŸ‡Έ

Atlanta, Georgia, United States

Princess Margaret Hospital

πŸ‡¨πŸ‡¦

Toronto, Ontario, Canada

Myron I Murdock MD LLC

πŸ‡ΊπŸ‡Έ

Greenbelt, Maryland, United States

Staten Island Urological Research

πŸ‡ΊπŸ‡Έ

Staten Island, New York, United States

Sunnybrook & Women's College HSC

πŸ‡¨πŸ‡¦

Toronto, Ontario, Canada

Hematology/Oncology Associates of the Treasure Coast

πŸ‡ΊπŸ‡Έ

Port Saint Lucie, Florida, United States

New York University

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Lutheran General Cancer Center

πŸ‡ΊπŸ‡Έ

Park Ridge, Illinois, United States

The Urological Institute of Northeastern New York

πŸ‡ΊπŸ‡Έ

Albany, New York, United States

Beth Israel Cancer Center

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Urology of Virginia, PC

πŸ‡ΊπŸ‡Έ

Norfolk, Virginia, United States

Cancer Care Northwest

πŸ‡ΊπŸ‡Έ

Spokane, Washington, United States

London Health Sciences Centre

πŸ‡¨πŸ‡¦

London, Ontario, Canada

Loyola University

πŸ‡ΊπŸ‡Έ

Maywood, Illinois, United States

North Shore Hematology Oncology Associates

πŸ‡ΊπŸ‡Έ

East Setauket, New York, United States

McKay Urology

πŸ‡ΊπŸ‡Έ

Charlotte, North Carolina, United States

Clinical Cancer Center

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Mount Sinai School of Medicine

πŸ‡ΊπŸ‡Έ

New York, New York, United States

Jefferson Medical College

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Mary Crowley

πŸ‡ΊπŸ‡Έ

Dallas, Texas, United States

Miami Cancer Center

πŸ‡ΊπŸ‡Έ

Miami, Florida, United States

Seattle Cancer Care Alliance

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

Virginia Mason Medical Center

πŸ‡ΊπŸ‡Έ

Seattle, Washington, United States

UCLA

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

USC Keck School of Medicine

πŸ‡ΊπŸ‡Έ

Los Angeles, California, United States

Midwest Prostate & Urology Health Center

πŸ‡ΊπŸ‡Έ

Chicago, Illinois, United States

Indiana University

πŸ‡ΊπŸ‡Έ

Indianapolis, Indiana, United States

Albany Regional Cancer Center

πŸ‡ΊπŸ‡Έ

Albany, New York, United States

Cleveland Clinic Foundation

πŸ‡ΊπŸ‡Έ

Cleveland, Ohio, United States

Center for Urologic Care

πŸ‡ΊπŸ‡Έ

Bryn Mawr, Pennsylvania, United States

University of Wisconsin, Madison

πŸ‡ΊπŸ‡Έ

Madison, Wisconsin, United States

Wenatchee Valley Medical Center

πŸ‡ΊπŸ‡Έ

Wenatchee, Washington, United States

Can-Med Medical Research, Inc.

πŸ‡¨πŸ‡¦

Victoria, British Columbia, Canada

Hospital Notre Dame du CHUM

πŸ‡¨πŸ‡¦

Montreal, Quebec, Canada

UCSF Cancer Center

πŸ‡ΊπŸ‡Έ

San Francisco, California, United States

University of Minnesota

πŸ‡ΊπŸ‡Έ

Minneapolis, Minnesota, United States

Duke University Medical Center

πŸ‡ΊπŸ‡Έ

Durham, North Carolina, United States

University of Utah

πŸ‡ΊπŸ‡Έ

Salt Lake City, Utah, United States

Dana-Farber Cancer Institute

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Lombardi Cancer Center

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

Grand Strand Urology

πŸ‡ΊπŸ‡Έ

Myrtle Beach, South Carolina, United States

Nevada Cancer Institute

πŸ‡ΊπŸ‡Έ

Las Vegas, Nevada, United States

Associates in Urology, LLC

πŸ‡ΊπŸ‡Έ

West Orange, New Jersey, United States

Lahey Clinic (Department of Urology)

πŸ‡ΊπŸ‡Έ

Burlington, Massachusetts, United States

University of Cincinnati

πŸ‡ΊπŸ‡Έ

Cincinnati, Ohio, United States

Helen F. Graham Cancer Center

πŸ‡ΊπŸ‡Έ

Newark, Delaware, United States

Walter Reid Army Medical Center

πŸ‡ΊπŸ‡Έ

Washington, District of Columbia, United States

New York Medical College

πŸ‡ΊπŸ‡Έ

Hawthorne, New York, United States

Hackensack University Medical Center

πŸ‡ΊπŸ‡Έ

Hackensack, New Jersey, United States

University of Wisconsin

πŸ‡ΊπŸ‡Έ

Madison, Wisconsin, United States

Baylor College of Medicine

πŸ‡ΊπŸ‡Έ

Houston, Texas, United States

Sutter Cancer Center

πŸ‡ΊπŸ‡Έ

Sacramento, California, United States

Kaiser Permanente Medical Group

πŸ‡ΊπŸ‡Έ

Portland, Oregon, United States

Mayo Clinic

πŸ‡ΊπŸ‡Έ

Rochester, Minnesota, United States

EACRI

πŸ‡ΊπŸ‡Έ

Portland, Oregon, United States

St. Luke's Hospital Immunotherapy Program

πŸ‡ΊπŸ‡Έ

Milwaukee, Wisconsin, United States

Sharp HealthCare

πŸ‡ΊπŸ‡Έ

San Diego, California, United States

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