Phase II GM-CSF Plus Mitoxantrone in Hormone Refractory Prostate Cancer

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Prostatic Neoplasms
Interventions:	Drug: Mitoxantrone; Drug: GM-CSF

  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
GM-CSF Plus Mitoxantrone	GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days

Participant Flow:   Overall Study

	GM-CSF Plus Mitoxantrone
STARTED	10
COMPLETED	10
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.
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Reporting Groups

	Description
GM-CSF Plus Mitoxantrone	GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days

Baseline Measures

	GM-CSF Plus Mitoxantrone
Overall Participants Analyzed; [Units: Participants]	10
Age; [Units: Participants]; Count of Participants
<=18 years	0 0.0%
Between 18 and 65 years	0 0.0%
>=65 years	10 100.0%
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	0 0.0%
Male	10 100.0%
Ethnicity (NIH/OMB); [Units: Participants]; Count of Participants
Hispanic or Latino	0 0.0%
Not Hispanic or Latino	10 100.0%
Unknown or Not Reported	0 0.0%
Race (NIH/OMB); [Units: Participants]; Count of Participants
American Indian or Alaska Native	0 0.0%
Asian	1 10.0%
Native Hawaiian or Other Pacific Islander	0 0.0%
Black or African American	0 0.0%
White	7 70.0%
More than one race	0 0.0%
Unknown or Not Reported	2 20.0%

  Outcome Measures

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1. Primary:

Progression-free Survival (PFS) [ Time Frame: 18 months ]

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2. Secondary:

Number of Participants With > 50% Decrease in Prostate-specific Antigen Levels (PSA Response) [ Time Frame: 18 months ]

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3. Secondary:

Overall Survival (OS) [ Time Frame: 18 months ]

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  Serious Adverse Events

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  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:  

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  

Name/Title: Sandy Srinivas, MD; Professor of Medicine (Oncology)
Organization: Stanford University Medical Center
phone: 650-725-2078
e-mail: sandysri@stanford.edu

Responsible Party:	Sandy Srinivas, Stanford University
ClinicalTrials.gov Identifier:	NCT00477087 History of Changes
Other Study ID Numbers:	IRB-04738; 96817 ( Other Identifier: Stanford University alternate IRB Number ); PROS0017 ( Other Identifier: OnCore Number )
First Submitted:	May 18, 2007
First Posted:	May 22, 2007
Results First Submitted:	May 10, 2017
Results First Posted:	November 29, 2017
Last Update Posted:	November 29, 2017