Metastatic Androgen Independent Prostate CancerPhase 2NCT00849290
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
A Phase 2 study testing APC8015F in people with Metastatic Androgen Independent Prostate Cancer, run by Dendreon at 58 sites in 2 countries.
Trial summary
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442) Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Androgen Independent Prostate Cancer
- What is being tested?
- APC8015F
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Apr 2004to Apr 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Objective disease progression
- Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
Who cannot join
- 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)
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States53 sites
Albany Regional Cancer Center
Albany, New York
The Urological Institute of Northeastern New York
Albany, New York
Georgia Urology, P.A.
Atlanta, Georgia
Dana-Farber Cancer Institute
Boston, Massachusetts
Center for Urologic Care
Bryn Mawr, Pennsylvania
Lahey Clinic (Department of Urology)
Burlington, Massachusetts
McKay Urology
Charlotte, North Carolina
Midwest Prostate & Urology Health Center
Chicago, Illinois
University of Cincinnati
Cincinnati, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio
Mary Crowley
Dallas, Texas
Duke University Medical Center
Durham, North Carolina
North Shore Hematology Oncology Associates
East Setauket, New York
Myron I Murdock MD LLC
Greenbelt, Maryland
Hackensack University Medical Center
Hackensack, New Jersey
New York Medical College
Hawthorne, New York
Baylor College of Medicine
Houston, Texas
Indiana University
Indianapolis, Indiana
Nevada Cancer Institute
Las Vegas, Nevada
UCLA
Los Angeles, California
USC Keck School of Medicine
Los Angeles, California
University of Wisconsin, Madison
Madison, Wisconsin
University of Wisconsin
Madison, Wisconsin
Loyola University
Maywood, Illinois
Miami Cancer Center
Miami, Florida
St. Luke's Hospital Immunotherapy Program
Milwaukee, Wisconsin
University of Minnesota
Minneapolis, Minnesota
Grand Strand Urology
Myrtle Beach, South Carolina
Beth Israel Cancer Center
New York, New York
Clinical Cancer Center
New York, New York
Mount Sinai School of Medicine
New York, New York
New York University
New York, New York
Helen F. Graham Cancer Center
Newark, Delaware
Urology of Virginia, PC
Norfolk, Virginia
Lutheran General Cancer Center
Park Ridge, Illinois
Jefferson Medical College
Philadelphia, Pennsylvania
Hematology/Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida
EACRI
Portland, Oregon
Kaiser Permanente Medical Group
Portland, Oregon
Mayo Clinic
Rochester, Minnesota
Sutter Cancer Center
Sacramento, California
University of Utah
Salt Lake City, Utah
Kaiser Permanente Medical Group
San Diego, California
Sharp HealthCare
San Diego, California
UCSF Cancer Center
San Francisco, California
Seattle Cancer Care Alliance
Seattle, Washington
Virginia Mason Medical Center
Seattle, Washington
Cancer Care Northwest
Spokane, Washington
Staten Island Urological Research
Staten Island, New York
Lombardi Cancer Center
Washington D.C., District of Columbia
Walter Reid Army Medical Center
Washington D.C., District of Columbia
Wenatchee Valley Medical Center
Wenatchee, Washington
Associates in Urology, LLC
West Orange, New Jersey
Canada5 sites
London Health Sciences Centre
London, Ontario
Hospital Notre Dame du CHUM
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
Sunnybrook & Women's College HSC
Toronto, Ontario
Can-Med Medical Research, Inc.
Victoria, British Columbia
About this study
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
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
- Being tested
- APC8015F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APC8015FBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| APC8015F | Experimental | Not described Receives: Biological: APC8015F |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: periodically over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startApr 2004
- Primary completionJan 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Androgen Independent Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dendreon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Schellhammer, MD, Study chair, Devine Tidewater Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849290
- Sponsor's protocol ID
- PB01
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2009
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00849290
- Acronym / sponsor ID
- PB01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- DendreonIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Jan 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 23 Feb 2009 (estimated)
- Results
- Posted 11 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APC8015F | Experimental | Biological: APC8015F |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Objective disease progression
- Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APC8015FAPC8015F 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. | Biological | APC8015F |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- (Prostate Cancer Research Institute)Link provided by the sponsor.
- (National Prostate Cancer Coalition)Link provided by the sponsor.
- (USTOO International)Link provided by the sponsor.
Related trials for Metastatic Androgen Independent Prostate Cancer
Not yet recruitingPhase 1/2
REGN21353 Alone or in Combination With Nezastomig for Metastatic Castration-Resistant Prostate Cancer in Adult Participants
Metastatic Castration-Resistant Prostate Cancer, mCRPC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Schellhammer, MD study chair
Devine Tidewater Urology
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APC8015F in people with Metastatic Androgen Independent Prostate Cancer, run by Dendreon at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of APC8015F by Review of Reported Adverse Events (time frame: periodically over 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.