Safety and Effectiveness of a Vaccine for Prostate Cancer That Uses Each Patients' Own Immune Cells.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Darnell, Rockefeller University
ClinicalTrials.gov Identifier:
NCT00289341
First received: February 7, 2006
Last updated: January 11, 2013
Last verified: January 2013
Results First Received: August 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: vaccine vehicle only
Biological: DC/LNCaP

  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
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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
Dendritic Cells Pulsed With LNCaP (DC/LNCaP) 12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
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Participant Flow:   Overall Study
    Dendritic Cells Pulsed With LNCaP (DC/LNCaP)     Placebo  
STARTED     12     12  
COMPLETED     12     12  
NOT COMPLETED     0     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
Dendritic Cells Pulsed With LNCaP (DC/LNCaP) 12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
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Total Total of all reporting groups

Baseline Measures
    Dendritic Cells Pulsed With LNCaP (DC/LNCaP)     Placebo     Total  
Number of Participants  
[units: participants]
  12     12     24  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     6     13  
>=65 years     5     6     11  
Age  
[units: years]
Mean ± Standard Deviation
  62.5  ± 6.7     65.7  ± 9.2     64.0  ± 7.9  
Gender  
[units: participants]
     
Female     0     0     0  
Male     12     12     24  
Region of Enrollment  
[units: participants]
     
United States     12     12     24  



  Outcome Measures
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1.  Primary:   Adverse Event   [ Time Frame: End of blinded phase (wk 9) ]

2.  Primary:   Immunogenicity of the DC/LNCaP Vaccine. Pre- vs Post-vaccination Bulk T Cell Proliferation (3H Thymidine Incorporation) by Type of Antigen. The "Number" Indicated is the Median Difference of Post-Pre, of Each Antigen Group.   [ Time Frame: pre- vs post-vaccination. Pre-vaccination T cells were collected at Wk 0 and post-vaccination T cells were collected at Wk 13 ]

3.  Secondary:   Change in PSA Slope, Pre- vs Post-vaccination.   [ Time Frame: pre- vs post- vaccination PSA slopes. ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Mayu Frank
Organization: Rockefeller University
phone: 212-327-7443
e-mail: frankm@rockefeller.edu


No publications provided by Rockefeller University

Publications automatically indexed to this study:

Responsible Party: Robert Darnell, Rockefeller University
ClinicalTrials.gov Identifier: NCT00289341     History of Changes
Other Study ID Numbers: RDA 0466
Study First Received: February 7, 2006
Results First Received: August 8, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration