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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.
ClinicalTrials.gov Identifier: NCT00257322
Recruitment Status : Completed
First Posted : November 22, 2005
Results First Posted : April 26, 2016
Last Update Posted : October 31, 2018
Sponsor:
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
Enrollment 20
Recruitment Details 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 Subjects with known allergic or other adverse reaction to GM-CSF are excluded from study. Also pregnant and lactating women were excluded from study.
Arm/Group Title Chemo Therapy and GM-CSF
Hide Arm/Group Description Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
Period Title: Overall Study
Started 20 [1]
Completed 16 [2]
Not Completed 4
[1]
20 subjects accrued.
[2]
4 subjects withdrew from this study.
Arm/Group Title Chemo Therapy and GM-CSF
Hide Arm/Group Description Granulocyte-Macrophage Colony-Stimulating Factor
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  55.0%
>=65 years
9
  45.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
62.65  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Participants Exhibiting Immune Response
Hide Description Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Therapy and GM-CSF
Hide Arm/Group Description:
Granulocyte-Macrophage Colony-Stimulating Factor
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
11
  68.8%
2.Secondary Outcome
Title Response Rates and Overall Survival.
Hide Description Effect of cellular immune stimulation on response rates and overall survival. This is a secondary endpoint and while data will be recorded, a larger study with improved power will be necessary to confirm any improvements noted.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemo Therapy and GM-CSF
Hide Arm/Group Description:
Granulocyte-Macrophage Colony-Stimulating Factor
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Response Rates
16
 100.0%
Overall Survival
16
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemo Therapy and GM-CSF
Hide Arm/Group Description Granulocyte-Macrophage Colony-Stimulating Factor
All-Cause Mortality
Chemo Therapy and GM-CSF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemo Therapy and GM-CSF
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemo Therapy and GM-CSF
Affected / at Risk (%)
Total   0/20 (0.00%) 
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
ClinicalTrials.gov 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: October 31, 2018