Vaccine Therapy and Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Treating Patients With Prostate Cancer That Progressed After Surgery and/or Radiation Therapy - Study Results

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostate Cancer
Interventions:	Biological: vaccinia Biological: GM-CSF Biological: fowlpox Drug: bicalutamide Drug: goserelin

Participant Flow

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.

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
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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.

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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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.

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 ]

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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 ]

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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 ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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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, U10CA021115, E9802, CDR0000422430
Study First Received:	April 18, 2005
Results First Received:	October 19, 2012
Last Updated:	February 25, 2013
Health Authority:	United States: Food and Drug Administration