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

This study is currently recruiting participants.

Verified by Rockefeller University, July 2008

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00345293

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Biological: autologous dendritic cell vaccine (DC/PC3)	Phase I Phase II

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of Autologous Dendrtitic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Safety

Secondary Outcome Measures:

Immunogenicity
Clinical Response

Estimated Enrollment:	8
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Prostate cancer

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

Exclusion Criteria:

CNS metastasis

History of autoimmune disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345293

Contacts

Contact: Mayu Okawa Frank, MS ANP

212-327-7443

frankm@rockefeller.edu

Locations

United States, New York
Rockefeller University Hospital	Recruiting
New York, New York, United States, 10021
Contact: Caryne Roey 212-327-8409

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Robert B Darnell, MD PHD

Rockefeller University

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	RDA-0537
Study First Received:	June 26, 2006
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00345293
Health Authority:	United States: Food and Drug Administration

Keywords provided by Rockefeller University:

Prostate Cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 13, 2009