Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Memorial Sloan Kettering Cancer Center.
Information provided by (Responsible Party):
Rockefeller University Identifier:
First received: June 26, 2006
Last updated: September 19, 2013
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: Allocation: Non-Randomized
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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00345293

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

Responsible Party: Rockefeller University Identifier: NCT00345293     History of Changes
Other Study ID Numbers: RDA-0537
Study First Received: June 26, 2006
Last Updated: September 19, 2013
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 March 01, 2015