Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442) - Full Text View

Sponsor:	Dendreon
Information provided by:	Dendreon
ClinicalTrials.gov Identifier:	NCT00849290

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Sipuleucel-T

U.S. FDA Resources

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

Criteria

Inclusion Criteria:

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

Sponsors and Collaborators

Dendreon

Investigators

Study Chair:

Paul Schellhammer, MD

Devine Tidewater Urology

More Information

Additional Information:

(Prostate Cancer Research Institute) This link exits the ClinicalTrials.gov site

(USTOO International) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Elizabeth Smith, Dendreon Corporation
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:	October 8, 2010
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, 2012