Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Biological: autologous dendritic cell vaccine (DC/PC3)

Registration Number: NCT00345293

Lead Sponsor: Rockefeller University

Brief Summary: The purpose of this study is to assess the safety and activity of DC/PC3, a dendritic cell vaccine used as immunotherapy for prostate cancer. The vaccine is made with each participants' own immune cells obtained through blood donation. Dendritic cells are known to activate other immune cells such as T cells, that are able to mount an attack against cancer cells. The dendritic cell vaccine will be administered as injections every 2 weeks over a course of 2 months.

Detailed Description: See Brief Summary.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 13

Inclusion Criteria

Prostate cancer

Rising prostate specific antigen (PSA, 3 values, each measured at least 2 weeks apart) post initial therapy (ie, radiation, prostatectomy) human leukocyte antigen A2.1 (HLA-A2.1)

Exclusion Criteria

central nervous system metastasis

History of autoimmune disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DC/PC3 vaccine	autologous dendritic cell vaccine (DC/PC3)	3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)

Primary Outcome Measures

Name	Time	Method
Toxicity	through week 29	adverse events

Secondary Outcome Measures

Name	Time	Method
Clinical Response	Post treatment
Immunogenicity	pre and post treatment	The Tritiated thymidine proliferation assay is used to assess samples collected pre-treatment and those collected post-treatment; the outcome measure is the change in counts per minute (post-treatment counts minus pre-treatment counts).