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Vaccine Therapy in Treating Patients With Non-Metastatic Prostate Cancer

This study has been terminated.
(Study was terminated due to funding issues.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00814892
First received: December 24, 2008
Last updated: October 8, 2013
Last verified: October 2013
Results First Received: May 16, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: allogeneic tumor cell vaccine
Biological: therapeutic autologous dendritic cells

  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
Two (2) participants were recruited between Jan 2009 and March 2010 at Mayo Clinic. This trial was permanently closed in March 2010 due to funding issues. Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DC-APCC Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    DC-APCC  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Disease Progression                 1  
Study Termination                 1  



  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.
Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.

Reporting Groups
  Description
DC-APCC Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
    DC-APCC  
Number of Participants  
[units: participants]
  0  
Age  
[units: participants]
 
<=18 years      
Between 18 and 65 years      
>=65 years      
Age  
[units: years]
Mean ± Standard Deviation
   
Gender  
[units: participants]
 
Female      
Male      
Region of Enrollment  
[units: participants]
 
United States      



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Are Progression Free at One Year   [ Time Frame: One year ]

2.  Secondary:   Number of Participants With Severe Adverse Events   [ Time Frame: Every cycle during treatment (up to 14 cycles) ]

3.  Secondary:   Time to Prostate-cancer Specific Mortality   [ Time Frame: Registration to Prostate-cancer specific mortality (Up to 3 years) ]

4.  Secondary:   Time to Prostate-specific Antigen (PSA) Progression   [ Time Frame: Registration to PSA progression (Up to 3 years) ]

5.  Secondary:   Duration of PSA-based Response   [ Time Frame: Up to 3 years ]

6.  Secondary:   Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire   [ Time Frame: Baseline and cycle 1 ]

7.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 3 years ]


  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
No text entered.


  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: Dr. Manish Kohli
Organization: Mayo Clinic
phone: 507-284-2511
e-mail: kohli.manish@mayo.edu


No publications provided


Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00814892     History of Changes
Other Study ID Numbers: MC0554, MC0554, 06-004659
Study First Received: December 24, 2008
Results First Received: May 16, 2013
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration