A Clinical Trial That Looks at the Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients’ Own Immune Cells.

This study is ongoing, but not recruiting participants.

First Received: February 7, 2006 Last Updated: January 16, 2007 History of Changes

Sponsored by:	Rockefeller University
Information provided by:	Rockefeller University
ClinicalTrials.gov Identifier:	NCT00289341

Purpose

The purpose of this study is to assess the safety and activity of a type of vaccine as immune therapy for prostate cancer. This vaccine will be made for each participant’s own immune cells (called dendritic cells) obtained by blood donation. Dendritic cells are immune cells, whose role is to identify foreign antigens (bacteria, viruses, or tumor cells, for example) in the body and to activate other cells of the immune system to mount an attack on that foreign antigen. Each participant will be randomized into either Arm 1 (experimental treatment only) or Arm 2 (placebo first, then the experimental treatment). Participants will be given the vaccine and three boosters as an injection. After the placebo phase, each participant in Arm 2 will crossover to the treatment phase so that all participants will eventually receive the experimental treatment.

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

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Crossover Assignment
Official Title:	A Phase I/II Study of Autologous Dendritic Cells Pulsed With Apoptotic Tumor Cells (DC/LNCaP) Administered Subcutaneously to Prostate Cancer Patients.

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Safety of the DC/LNCaP vaccine
Immunogenicity of the DC/LNCaP vaccine
Clinical course of participants as measured by patient symptoms, PSAs, bone scans, CT scans.

Estimated Enrollment:

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 post initial therapy (ie radiation, prostatectomy)

Exclusion Criteria:

CNS metastasis
Prior autologous or allogeneic tumor vaccine treatments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289341

Locations

United States, New York
Rockefeller University Hospital
New York, New York, United States, 10021

Sponsors and Collaborators

Rockefeller University

Investigators

Principal Investigator:

Robert B. Darnell, MD, PHD

Rockefeller University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	RDA 0466
Study First Received:	February 7, 2006
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00289341 History of Changes
Health Authority:	United States: Food and Drug Administration

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
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009