Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
This study has been completed.
Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
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Purpose
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Androgen Independent Prostate Cancer |
Biological: APC8015F |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Dendreon:
Primary Outcome Measures:
- Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: periodically over 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 113 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849290
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| United States, California | |
| UCLA | |
| Los Angeles, California, United States | |
| USC Keck School of Medicine | |
| Los Angeles, California, United States | |
| Sutter Cancer Center | |
| Sacramento, California, United States | |
| Kaiser Permanente Medical Group | |
| San Diego, California, United States | |
| Sharp HealthCare | |
| San Diego, California, United States | |
| UCSF Cancer Center | |
| San Francisco, California, United States | |
| United States, Delaware | |
| Helen F. Graham Cancer Center | |
| Newark, Delaware, United States | |
| United States, District of Columbia | |
| Walter Reid Army Medical Center | |
| Washington, District of Columbia, United States | |
| Lombardi Cancer Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| Miami Cancer Center | |
| Miami, Florida, United States | |
| Hematology/Oncology Associates of the Treasure Coast | |
| Port St. Lucie, Florida, United States | |
| United States, Georgia | |
| Georgia Urology, P.A. | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Midwest Prostate & Urology Health Center | |
| Chicago, Illinois, United States | |
| Loyola University | |
| Maywood, Illinois, United States | |
| Lutheran General Cancer Center | |
| Park Ridge, Illinois, United States | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States | |
| United States, Maryland | |
| Myron I Murdock MD LLC | |
| Greenbelt, Maryland, United States | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States | |
| Lahey Clinic (Department of Urology) | |
| Burlington, Massachusetts, United States | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States | |
| Mayo Clinic | |
| Rochester, Minnesota, United States | |
| United States, Nevada | |
| Nevada Cancer Institute | |
| Las Vegas, Nevada, United States | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States | |
| Associates in Urology, LLC | |
| West Orange, New Jersey, United States | |
| United States, New York | |
| The Urological Institute of Northeastern New York | |
| Albany, New York, United States | |
| Albany Regional Cancer Center | |
| Albany, New York, United States | |
| North Shore Hematology Oncology Associates | |
| East Setauket, New York, United States | |
| New York Medical College | |
| Hawthorne, New York, United States | |
| Clinical Cancer Center | |
| 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 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States | |
| Staten Island Urological Research | |
| Staten Island, New York, United States | |
| United States, North Carolina | |
| McKay Urology | |
| Charlotte, North Carolina, United States | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States | |
| United States, Oregon | |
| EACRI | |
| Portland, Oregon, United States | |
| Kaiser Permanente Medical Group | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Center for Urologic Care | |
| Bryn Mawr, Pennsylvania, United States | |
| Jefferson Medical College | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| Grand Strand Urology | |
| Myrtle Beach, South Carolina, United States | |
| United States, Texas | |
| Mary Crowley | |
| Dallas, Texas, United States | |
| Baylor College of Medicine | |
| Houston, Texas, United States | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Urology of Virginia, PC | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Virginia Mason Medical Center | |
| Seattle, Washington, United States | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States | |
| Cancer Care Northwest | |
| Spokane, Washington, United States | |
| Wenatchee Valley Medical Center | |
| Wenatchee, Washington, United States | |
| United States, Wisconsin | |
| University of Wisconsin, Madison | |
| Madison, Wisconsin, United States | |
| University of Wisconsin | |
| Madison, Wisconsin, United States | |
| St. Luke's Hospital Immunotherapy Program | |
| Milwaukee, Wisconsin, United States | |
| Canada, British Columbia | |
| Can-Med Medical Research, Inc. | |
| Victoria, British Columbia, Canada | |
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada | |
| Sunnybrook & Women's College HSC | |
| Toronto, Ontario, Canada | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Hospital Notre Dame du CHUM | |
| Montreal, Quebec, Canada | |
Sponsors and Collaborators
Dendreon
Investigators
| Study Chair: | Paul Schellhammer, MD | Devine Tidewater Urology |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dendreon |
| ClinicalTrials.gov Identifier: | NCT00849290 History of Changes |
| Obsolete Identifiers: | NCT00090922, NCT00170066, NCT00513006 |
| Other Study ID Numbers: | PB01 |
| Study First Received: | February 19, 2009 |
| Results First Received: | May 28, 2010 |
| Last Updated: | March 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Disease Progression Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013