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Cellular Immune Augmentation in Colon and Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00257322
First received: November 18, 2005
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: June 26, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colon Cancer
Rectal Cancer
Intervention: 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
20 subjects enrolled between Jun 2003 and Jan 2007 in UCIMC location. All subjects undergoing treatment are presented with all options for their care - research or non-research.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with known allergic or other adverse reaction to GM-CSF are excluded from study. Also pregnant and lactating women were excluded from study.

Reporting Groups
  Description
Chemo Therapy and GM-CSF Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD

Participant Flow:   Overall Study
    Chemo Therapy and GM-CSF  
STARTED     20 [1]
COMPLETED     16 [2]
NOT COMPLETED     4  
[1] 20 subjects accrued.
[2] 4 subjects withdrew from this study.



  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
Chemo Therapy and GM-CSF Granulocyte-Macrophage Colony-Stimulating Factor

Baseline Measures
    Chemo Therapy and GM-CSF  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     9  
Age  
[units: years]
Mean (Standard Deviation)
  62.65  (13.52)  
Gender  
[units: participants]
 
Female     11  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures
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1.  Primary:   Participants Exhibiting Immune Response   [ Time Frame: 24 Months ]

2.  Secondary:   Response Rates and Overall Survival.   [ Time Frame: 24 Months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chao Family Comprehensive Cancer Center
Organization: University of California, Irvine
phone: (877) 827-8839
e-mail: UCstudy@uci.edu



Responsible Party: Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00257322     History of Changes
Other Study ID Numbers: UCI 02-60
2003-2876 ( Other Identifier: University of California, Irvine )
Study First Received: November 18, 2005
Results First Received: June 26, 2009
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board