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GM-CSF in Treating Patients With Relapsed Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00908141
First received: May 22, 2009
Last updated: August 15, 2013
Last verified: August 2013
Results First Received: May 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Biological: sargramostim

  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
Patients recruited from local medical clinic from June 2006 to August 2010.

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
Group A: Sargramostim (Days 1-14)

GROUP A:

Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle

Group B:Sargramostim (3 x Week)

GROUP B:

Sargramostim 250ug subcutaneously (s.c.) three times a week continuously


Participant Flow:   Overall Study
    Group A: Sargramostim (Days 1-14)     Group B:Sargramostim (3 x Week)  
STARTED     8     9  
COMPLETED     8     8  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 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.
No text entered.

Reporting Groups
  Description
Group A: Sargramostim (Days 1-14)

GROUP A:

Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle

Group B: Sargramostim (3 x Week)

GROUP B:

Sargramostim 250ug subcutaneously (s.c.) three times a week continuously

Total Total of all reporting groups

Baseline Measures
    Group A: Sargramostim (Days 1-14)     Group B: Sargramostim (3 x Week)     Total  
Number of Participants  
[units: participants]
  8     9     17  
Age, Customized  
[units: participants]
     
40-49 years     1     0     1  
50-59 years     2     2     4  
60-69 years     2     4     6  
70-79 years     3     3     6  
Gender  
[units: participants]
     
Female     0     0     0  
Male     8     9     17  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     8     9     17  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     8     8     16  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     8     9     17  



  Outcome Measures

1.  Primary:   Prostate Specific Antigen (PSA) Response   [ Time Frame: post treatment at 9 weeks ]


  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
No text entered.


  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: Robert Dreicer MD
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-4623
e-mail: dreicer@ccf.org


No publications provided


Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00908141     History of Changes
Other Study ID Numbers: CASE6805, P30CA043703, CASE6805, 8201
Study First Received: May 22, 2009
Results First Received: May 20, 2013
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board