Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer - Full Text View

Sponsors and Collaborators:	Rockefeller University Memorial Sloan-Kettering Cancer Center
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

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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Rockefeller University:

Primary Outcome Measures:

Toxicity [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity [ Time Frame: Day 0, Week 3, 4, 5, 7, 9, 13, 17 ] [ Designated as safety issue: No ]
Clinical Response [ Time Frame: baseline, and at 5 weeks and 17 weeks after completion of ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	June 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
DC/PC3 vaccine: Experimental 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)	Biological: autologous dendritic cell vaccine (DC/PC3) 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 leukapheresate, 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

Arms

Assigned Interventions

DC/PC3 vaccine: Experimental

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)

Biological: autologous dendritic cell vaccine (DC/PC3)

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 leukapheresate, 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

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

Locations

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

Sponsors and Collaborators

Rockefeller University

Memorial Sloan-Kettering Cancer Center

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

Responsible Party:	Rockefeller University ( Robert Darnell, MD )
Study ID Numbers:	RDA-0537
Study First Received:	June 26, 2006
Last Updated:	April 29, 2009
ClinicalTrials.gov Identifier:	NCT00345293 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

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
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009