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

Study Overview
=================
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.

Official Title
-----------------
A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Biological: autologous dendritic cell vaccine (DC/PC3)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC/PC3 vaccine<br>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) | Biological: autologous dendritic cell vaccine (DC/PC3)<br>* ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | adverse events | through week 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 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). | pre and post treatment | 
| Clinical Response |  | Post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer