A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00108732
First received: April 18, 2005
Last updated: April 22, 2014
Last verified: December 2013
Results First Received: October 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Interventions: Biological: sargramostim
Biological: recombinant vaccinia-TRICOM vaccine
Biological: fowlpox-PSA-TRICOM vaccine
Drug: bicalutamide
Drug: goserelin acetate

  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

The study was activated on February 3, 2006 and terminated on December 11, 2007 after reaching its accrual goal. A total of 50 patients were recruited from ECOG member institutions.

Patients with biochemical or clinical progression during Step 1 were eligible to receive androgen blockade in Step 2. To date, 31 patients have registered to Step 2.


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
Vaccinia/Fowlpox/GM-CSF

There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.

Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.

Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months.


Participant Flow for 2 periods

Period 1:   Step 1 (Vaccinia/Fowlpox/GM-CSF)
    Vaccinia/Fowlpox/GM-CSF  
STARTED     50  
Eligible and Treated     40  
COMPLETED     36  
NOT COMPLETED     14  
Adverse Event                 1  
Withdrawal by Subject                 2  
Ineligible                 10  
Non-compliance                 1  

Period 2:   Step 2 (Androgen Ablation and Vaccine)
    Vaccinia/Fowlpox/GM-CSF  
STARTED     31  
COMPLETED     26  
NOT COMPLETED     5  
Adverse Event                 3  
Withdrawal by Subject                 1  
Unknown                 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.
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Reporting Groups
  Description
Vaccinia/Fowlpox/GM-CSF

Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.

Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months.


Baseline Measures
    Vaccinia/Fowlpox/GM-CSF  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Median ( Full Range )
  62.5  
  ( 48 to 77 )  
Gender  
[units: participants]
 
Female     0  
Male     40  



  Outcome Measures
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1.  Primary:   Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)   [ Time Frame: Assessed at 6 months ]

2.  Secondary:   Proportion of Patients With PSA Response   [ Time Frame: Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months ]

3.  Secondary:   Difference Between Day 4 PSA Level and Day 15 PSA Level   [ Time Frame: Assessed at day 4 and day 15 of cycle 1 ]

4.  Secondary:   The Difference Between PSA Slopes Before and After Treatment   [ Time Frame: Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00108732     History of Changes
Other Study ID Numbers: NCI-2012-03075, NCI-2012-03075, ECOG-E9802, E9802, E9802, U10CA021115
Study First Received: April 18, 2005
Results First Received: October 19, 2012
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration