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
Results First Received: June 24, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Biological: autologous dendritic cell vaccine (DC/PC3)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
DC/PC3 Vaccine-selected 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) 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 10^6 DCs. DCs were made from precursors isolated using antibodies.
DC/PC3- Adherent 3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) 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 10^6 DCs. DCs were made from precursors isolated using the adherence method.

Participant Flow:   Overall Study
    DC/PC3 Vaccine-selected     DC/PC3- Adherent  
STARTED     10     3  
COMPLETED     8     3  
NOT COMPLETED     2     0  
Unable to access line for sample                 1                 0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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)

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


Baseline Measures
    DC/PC3 Vaccine  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Mean (Full Range)
  64  
  (53 to 76)  
Gender  
[units: participants]
 
Female     0  
Male     13  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     13  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     11  
More than one race     1  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Toxicity   [ Time Frame: through week 29 ]

2.  Secondary:   Immunogenicity   [ Time Frame: pre and post treatment ]

3.  Secondary:   Clinical Response   [ Time Frame: Post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mayu Frank, MS, ANP, Clinical Research Nurse Practitioner
Organization: Rockefeller University
phone: 212-327-7443
e-mail: frankm@rockefeller.edu


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