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

November 10, 2023 updated by: Dendreon

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

This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APC8015F
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of APC8015F by Review of Reported Adverse Events
Time Frame: 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.
periodically over 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response
Time Frame: periodically over 24 months
To compare the within-subject pre-and-post-APC8015F PSADT. The pre-and-post-APC8015F PSADT for each subject refers to the PSADT while on Protocol D9902B and Protocol PB01, respectively.
periodically over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Investigators

  • Study Chair: Paul Schellhammer, MD, Devine Tidewater Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 19, 2009

First Submitted That Met QC Criteria

February 19, 2009

First Posted (Estimated)

February 23, 2009

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PB01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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