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Docetaxel and Immunotherapy Prior to Prostatectomy for High-Risk Prostate Cancer

This study has been terminated.
(Safety reasons, though no safety issues arose.)
Sponsor:
Collaborators:
Cell Genesys
Sanofi
Information provided by:
Benaroya Research Institute
ClinicalTrials.gov Identifier:
NCT00577356
First received: December 18, 2007
Last updated: January 18, 2011
Last verified: November 2010
Results First Received: September 13, 2010  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Docetaxel
Biological: CG1940/CG8711

  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
Recruitment from Feb. 08 through September 08 at Virginia Mason Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible patients had histologically confirmed adenocarcinoma of the prostate with clinical stage 1-3, no evidence of metastatic disease, and were appropriate candidates for radical prostatectomy with an estimated life expectancy >10 years.

Reporting Groups
  Description
CG1940/CG8711 (Immunotherapy Drug) Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).

Participant Flow:   Overall Study
    CG1940/CG8711 (Immunotherapy Drug)  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
CG1940/CG8711 (Immunotherapy Drug) Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).

Baseline Measures
    CG1940/CG8711 (Immunotherapy Drug)  
Number of Participants  
[units: participants]
  6  
Age, Customized  
[units: participants]
 
<55 years     6  
Gender  
[units: participants]
 
Female     0  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     6  
adenocarcinoma of the prostate and no radiographic evidence of metastatic disease  
[units: years]
Mean ± Standard Deviation
  2  ± 7.1  
Prostate Cancer  
[units: participants]
  6  



  Outcome Measures

1.  Primary:   Number of Participants With Pathological Complete Response.   [ Time Frame: The study evaluates 4 months of docetaxel and immunotherapy prior to radical prostatectomy followed by radical prostatectomy with an additional 3 months of immunotherapy after radical prostatectomy. ]


  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
the trial was closed prior to planned accrual of 30 patients due to an external report from the randomized trial of docetaxel and CG1940/CG8711 resulting in a higher incidence of deaths compared to docetaxel alone in metastatic prostate cancer.


  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: Jacqueline Vuky, MD
Organization: Virginia Mason Medical Center
phone: (206) 223-6193 ext 32246
e-mail: Jacqueline.Vuky@vmmc.org


No publications provided


Responsible Party: Jacqueline Vuky, MD, Virginia Mason Medical Center
ClinicalTrials.gov Identifier: NCT00577356     History of Changes
Other Study ID Numbers: IRB07028, I-0057, IST# 16194
Study First Received: December 18, 2007
Results First Received: September 13, 2010
Last Updated: January 18, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board