Completed

NCT Number: NCT00849290

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

This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)

Completed

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Key information

Conditions

Metastatic Androgen Independent Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Can-Med Medical Research, Inc., Victoria, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

APC8015F

Biological

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dendreon

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Feb 23, 2009
Registry last updated: Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.