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

This study is enrolling participants by invitation only.

First Received: February 19, 2009 Last Updated: March 20, 2009 History of Changes

Sponsored by:	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

Condition	Intervention	Phase
Metastatic Androgen Independent Prostate Cancer	Biological: APC8015F	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Provenge Sipuleucel-T

U.S. FDA Resources

Further study details as provided by Dendreon:

Primary Outcome Measures:

To assess the safety of APC8015F [ Time Frame: periodically over 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the efficacy of APC8015F in delaying prostate specific antigen (PSA) doubling time (PSADT) and on overall clinical response [ Time Frame: periodically over 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	July 2003
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
APC8015F: Experimental	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
Must be enrolled in the APC-Placebo arm of D9902B

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

Show 61 Study Locations

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

(National Prostate Cancer Coalition) This link exits the ClinicalTrials.gov site

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

(American Foundation of Urological Diseases) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Dendreon Corporation ( Elizabeth Smith )
Study ID Numbers:	PB01
Study First Received:	February 19, 2009
Last Updated:	March 20, 2009
ClinicalTrials.gov Identifier:	NCT00849290 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Disease Progression

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009