NCT00849290

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

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00849290

Principal Investigator:

Study Type:

INTERVENTIONAL

Official 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

Summary

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

Eligibility

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)

Disease(s) and\or Condition(s)

Metastatic Androgen Independent Prostate Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: APC8015F
- Description: 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.
- Arm Group Labels: APC8015F

Sponsor

Dendreon