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
  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 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 Dendritic 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: through week 29 ] [ Designated as safety issue: Yes ]
    adverse events


Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: June 2006
Study Completion Date: March 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 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

Detailed Description:
See Brief Summary.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier: NCT00345293

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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT00345293     History of Changes
Other Study ID Numbers: RDA-0537 
Study First Received: June 26, 2006
Results First Received: June 24, 2015
Last Updated: April 1, 2016
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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016