Cellular Immune Augmentation in Colon and Rectal Cancer

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. Identifier: NCT00257322
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Colon Cancer
Rectal Cancer
Intervention: Drug: GM-CSF

  Participant Flow

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
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] 
[1] 20 subjects accrued.
[2] 4 subjects withdrew from this study.

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

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

  Outcome Measures

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

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

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

Responsible Party: Chao Family Comprehensive Cancer Center, University of California, Irvine Identifier: NCT00257322     History of Changes
Other Study ID Numbers: UCI 02-60
2003-2876 ( Other Identifier: University of California, Irvine )
First Submitted: November 18, 2005
First Posted: November 22, 2005
Results First Submitted: June 26, 2009
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016