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Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939510
First Posted: July 15, 2009
Last Update Posted: January 31, 2013
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:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert Dreicer MD, Case Comprehensive Cancer Center
Results First Submitted: April 26, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: sargramostim
Drug: lenalidomide
Other: laboratory biomarker analysis

  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 were recruited from November 2005 to April 2009 from medical clinic

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
Lenalidomide (Revlimid) and Sargramostim (GM-CSF) Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.

Participant Flow:   Overall Study
    Lenalidomide (Revlimid) and Sargramostim (GM-CSF)
STARTED   32 
COMPLETED   31 
NOT COMPLETED   1 
Withdrawal by Subject                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
Lenalidomide (Revlimid) and Sargramostim (GM-CSF) Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.

Baseline Measures
   Lenalidomide (Revlimid) and Sargramostim (GM-CSF) 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.7  (7.3) 
Gender 
[Units: Participants]
 
Female   0 
Male   32 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   29 
Unknown or Not Reported   3 
Race (NIH/OMB) 
[Units: Particpants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   3 
White   27 
More than one race   0 
Unknown or Not Reported   2 
Region of Enrollment 
[Units: Participants]
 
United States   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With a PSA Response   [ Time Frame: reevaluated for response every eight weeks ]

2.  Primary:   RECIST-defined Measurable Disease   [ Time Frame: every 8 weeks and at end of treatment ]

3.  Secondary:   Number of Patients With Statistically Significant Change in Immune Response From Baseline to End of Study   [ Time Frame: every 28 days for first 3 cycles, end of study ]


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


Results Point of Contact:  
Name/Title: Dr. Robert Dreicer
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-445-4623
e-mail: dreicer@ccf.org



Responsible Party: Robert Dreicer MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00939510     History of Changes
Other Study ID Numbers: CASE3805
P30CA043703 ( U.S. NIH Grant/Contract )
IRB# 8121 ( Other Identifier: Cleveland Clinic IRB )
RV-PCA-PI-059
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: April 26, 2012
Results First Posted: July 12, 2012
Last Update Posted: January 31, 2013