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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dendreon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2009

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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