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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00345293
First received: June 26, 2006
Last updated: September 19, 2013
Last verified: September 2013

June 26, 2006
September 19, 2013
June 2006
December 2013   (final data collection date for primary outcome measure)
Toxicity [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Safety
Complete list of historical versions of study NCT00345293 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Immunogenicity
  • Clinical Response
Not Provided
Not Provided
 
Dendritic Cell Vaccine Study (DC/PC3) for Prostate Cancer
A Phase I/II Study of Autologous Dendrtitic Cells Pulsed With Apoptotic Tumor Cells (DC/PC3) Administered Subcutaneously to Prostate Cancer Patients.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
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
Experimental: DC/PC3 vaccine
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)
Intervention: Biological: autologous dendritic cell vaccine (DC/PC3)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345293
RDA-0537
Yes
Rockefeller University
Rockefeller University
Memorial Sloan-Kettering Cancer Center
Principal Investigator: Robert B Darnell, MD PHD Rockefeller University
Rockefeller University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP