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

This study has been completed.
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: April 1, 2016
Last verified: April 2016

June 26, 2006
April 1, 2016
June 2006
December 2013   (final data collection date for primary outcome measure)
Toxicity [ Time Frame: through week 29 ] [ Designated as safety issue: Yes ]
adverse events
Safety
Complete list of historical versions of study NCT00345293 on ClinicalTrials.gov Archive Site
  • Immunogenicity [ Time Frame: pre and post treatment ] [ Designated as safety issue: No ]
    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).
  • Clinical Response [ Time Frame: Post treatment ] [ 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 Dendritic 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.
See Brief Summary.
Interventional
Phase 1
Phase 2
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 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
Experimental: DC/PC3 vaccine
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)
Intervention: Biological: autologous dendritic cell vaccine (DC/PC3)
Frank MO, Kaufman J, Parveen S, Blachère NE, Orange DE, Darnell RB. Dendritic cell vaccines containing lymphocytes produce improved immunogenicity in patients with cancer. J Transl Med. 2014 Dec 5;12:338. doi: 10.1186/s12967-014-0338-3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
March 2015
December 2013   (final data collection date for primary outcome measure)

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

Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00345293
RDA-0537
Yes
Not Provided
Not Provided
Rockefeller University
Rockefeller University
Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert B Darnell, MD PHD Rockefeller University
Rockefeller University
April 2016

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