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

NCT ID: NCT00849290

Last Updated: 2023-11-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-04-30

Brief Summary

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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

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Conditions

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Metastatic Androgen Independent Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APC8015F

Group Type EXPERIMENTAL

APC8015F

Intervention Type BIOLOGICAL

APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Interventions

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APC8015F

APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dendreon

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Schellhammer, MD

Role: STUDY_CHAIR

Devine Tidewater Urology

Locations

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UCLA

Los Angeles, California, United States

Site Status

USC Keck School of Medicine

Los Angeles, California, United States

Site Status

Sutter Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente Medical Group

San Diego, California, United States

Site Status

Sharp HealthCare

San Diego, California, United States

Site Status

UCSF Cancer Center

San Francisco, California, United States

Site Status

Helen F. Graham Cancer Center

Newark, Delaware, United States

Site Status

Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Walter Reid Army Medical Center

Washington D.C., District of Columbia, United States

Site Status

Miami Cancer Center

Miami, Florida, United States

Site Status

Hematology/Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

Georgia Urology, P.A.

Atlanta, Georgia, United States

Site Status

Midwest Prostate & Urology Health Center

Chicago, Illinois, United States

Site Status

Loyola University

Maywood, Illinois, United States

Site Status

Lutheran General Cancer Center

Park Ridge, Illinois, United States

Site Status

Indiana University

Indianapolis, Indiana, United States

Site Status

Myron I Murdock MD LLC

Greenbelt, Maryland, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Lahey Clinic (Department of Urology)

Burlington, Massachusetts, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Nevada Cancer Institute

Las Vegas, Nevada, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Associates in Urology, LLC

West Orange, New Jersey, United States

Site Status

Albany Regional Cancer Center

Albany, New York, United States

Site Status

The Urological Institute of Northeastern New York

Albany, New York, United States

Site Status

North Shore Hematology Oncology Associates

East Setauket, New York, United States

Site Status

New York Medical College

Hawthorne, New York, United States

Site Status

Beth Israel Cancer Center

New York, New York, United States

Site Status

Clinical Cancer Center

New York, New York, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

New York University

New York, New York, United States

Site Status

Staten Island Urological Research

Staten Island, New York, United States

Site Status

McKay Urology

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

EACRI

Portland, Oregon, United States

Site Status

Kaiser Permanente Medical Group

Portland, Oregon, United States

Site Status

Center for Urologic Care

Bryn Mawr, Pennsylvania, United States

Site Status

Jefferson Medical College

Philadelphia, Pennsylvania, United States

Site Status

Grand Strand Urology

Myrtle Beach, South Carolina, United States

Site Status

Mary Crowley

Dallas, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Urology of Virginia, PC

Norfolk, Virginia, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Cancer Care Northwest

Spokane, Washington, United States

Site Status

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Site Status

University of Wisconsin, Madison

Madison, Wisconsin, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

St. Luke's Hospital Immunotherapy Program

Milwaukee, Wisconsin, United States

Site Status

Can-Med Medical Research, Inc.

Victoria, British Columbia, Canada

Site Status

London Health Sciences Centre

London, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Sunnybrook & Women's College HSC

Toronto, Ontario, Canada

Site Status

Hospital Notre Dame du CHUM

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.pcacoalition.org

(National Prostate Cancer Coalition)

http://www.ustoo.com

(USTOO International)

Other Identifiers

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PB01

Identifier Type: -

Identifier Source: org_study_id

NCT00090922

Identifier Type: -

Identifier Source: nct_alias

NCT00170066

Identifier Type: -

Identifier Source: nct_alias

NCT00513006

Identifier Type: -

Identifier Source: nct_alias