Lenalidomide and GM-CSF in Treating Patients With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Dreicer MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00939510
First received: July 14, 2009
Last updated: January 24, 2013
Last verified: January 2013
Results First Received: April 26, 2012  
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: 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)  
Number of Participants  
[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
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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


No publications provided


Responsible Party: Robert Dreicer MD, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00939510     History of Changes
Other Study ID Numbers: CASE3805, P30CA043703, IRB# 8121, RV-PCA-PI-059
Study First Received: July 14, 2009
Results First Received: April 26, 2012
Last Updated: January 24, 2013
Health Authority: United States: Food and Drug Administration