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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2013 by Rockefeller University.
Recruitment status was  Active, not recruiting
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Rockefeller University Identifier:
First received: June 26, 2006
Last updated: March 17, 2015
Last verified: September 2013

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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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 Study Completion Date: June 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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

Detailed Description:

See Brief Summary.


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

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT00345293

United States, New York
Rockefeller University Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert B Darnell, MD PHD Rockefeller University
  More Information

Additional Information:
No publications provided by Rockefeller University

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rockefeller University Identifier: NCT00345293     History of Changes
Other Study ID Numbers: RDA-0537
Study First Received: June 26, 2006
Last Updated: March 17, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rockefeller University:
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on October 09, 2015