We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477087
First Posted: May 22, 2007
Last Update Posted: November 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
Results First Submitted: May 10, 2017  
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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
  Hide Baseline Characteristics

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
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
  Show All Outcome Measures

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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