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

Primary Purpose

Metastatic Androgen Independent Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APC8015F
Sponsored by
Dendreon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Androgen Independent Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • UCLA
  • USC Keck School of Medicine
  • Sutter Cancer Center
  • Kaiser Permanente Medical Group
  • Sharp HealthCare
  • UCSF Cancer Center
  • Helen F. Graham Cancer Center
  • Lombardi Cancer Center
  • Walter Reid Army Medical Center
  • Miami Cancer Center
  • Hematology/Oncology Associates of the Treasure Coast
  • Georgia Urology, P.A.
  • Midwest Prostate & Urology Health Center
  • Loyola University
  • Lutheran General Cancer Center
  • Indiana University
  • Myron I Murdock MD LLC
  • Dana-Farber Cancer Institute
  • Lahey Clinic (Department of Urology)
  • University of Minnesota
  • Mayo Clinic
  • Nevada Cancer Institute
  • Hackensack University Medical Center
  • Associates in Urology, LLC
  • Albany Regional Cancer Center
  • The Urological Institute of Northeastern New York
  • North Shore Hematology Oncology Associates
  • New York Medical College
  • Beth Israel Cancer Center
  • Clinical Cancer Center
  • Mount Sinai School of Medicine
  • New York University
  • Staten Island Urological Research
  • McKay Urology
  • Duke University Medical Center
  • University of Cincinnati
  • Cleveland Clinic Foundation
  • EACRI
  • Kaiser Permanente Medical Group
  • Center for Urologic Care
  • Jefferson Medical College
  • Grand Strand Urology
  • Mary Crowley
  • Baylor College of Medicine
  • University of Utah
  • Urology of Virginia, PC
  • Seattle Cancer Care Alliance
  • Virginia Mason Medical Center
  • Cancer Care Northwest
  • Wenatchee Valley Medical Center
  • University of Wisconsin, Madison
  • University of Wisconsin
  • St. Luke's Hospital Immunotherapy Program
  • Can-Med Medical Research, Inc.
  • London Health Sciences Centre
  • Princess Margaret Hospital
  • Sunnybrook & Women's College HSC
  • Hospital Notre Dame du CHUM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

APC8015F

Arm Description

Outcomes

Primary Outcome Measures

Safety of APC8015F by Review of Reported Adverse Events
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

To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response
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.

Full Information

First Posted
February 19, 2009
Last Updated
September 3, 2021
Sponsor
Dendreon
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1. Study Identification

Unique Protocol Identification Number
NCT00849290
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dendreon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Androgen Independent Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APC8015F
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
APC8015F
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety of APC8015F by Review of Reported Adverse Events
Description
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.
Time Frame
periodically over 24 months
Secondary Outcome Measure Information:
Title
To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response
Description
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.
Time Frame
periodically over 24 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Schellhammer, MD
Organizational Affiliation
Devine Tidewater Urology
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
Country
United States
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
San Diego
State/Province
California
Country
United States
Facility Name
Sharp HealthCare
City
San Diego
State/Province
California
Country
United States
Facility Name
UCSF Cancer Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Walter Reid Army Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Miami Cancer Center
City
Miami
State/Province
Florida
Country
United States
Facility Name
Hematology/Oncology Associates of the Treasure Coast
City
Port Saint Lucie
State/Province
Florida
Country
United States
Facility Name
Georgia Urology, P.A.
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Midwest Prostate & Urology Health Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
Lutheran General Cancer Center
City
Park Ridge
State/Province
Illinois
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Myron I Murdock MD LLC
City
Greenbelt
State/Province
Maryland
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Lahey Clinic (Department of Urology)
City
Burlington
State/Province
Massachusetts
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Associates in Urology, LLC
City
West Orange
State/Province
New Jersey
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
Country
United States
Facility Name
The Urological Institute of Northeastern New York
City
Albany
State/Province
New York
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
East Setauket
State/Province
New York
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
Country
United States
Facility Name
Beth Israel Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Clinical Cancer Center
City
New York
State/Province
New York
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
Country
United States
Facility Name
Staten Island Urological Research
City
Staten Island
State/Province
New York
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
EACRI
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Center for Urologic Care
City
Bryn Mawr
State/Province
Pennsylvania
Country
United States
Facility Name
Jefferson Medical College
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Mary Crowley
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Urology of Virginia, PC
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
St. Luke's Hospital Immunotherapy Program
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Can-Med Medical Research, Inc.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook & Women's College HSC
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hospital Notre Dame du CHUM
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.pcacoalition.org
Description
(National Prostate Cancer Coalition)
URL
http://www.ustoo.com
Description
(USTOO International)

Learn more about this trial

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

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