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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  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:

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

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

  Show 58 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
(USTOO International)  This link exits the ClinicalTrials.gov site

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 22, 2013