Trial Outcomes & Findings for Cellular Immune Augmentation in Colon and Rectal Cancer (NCT NCT00257322)

Results Overview

Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

24 Months

Results posted on

2018-10-31

Participant Flow

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.

Subjects with known allergic or other adverse reaction to GM-CSF are excluded from study. Also pregnant and lactating women were excluded from study.

Participant milestones

Participant milestones
Measure	Chemo Therapy and GM-CSF Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m\^2 SQ QD with a cap of 500mcg SQ QD
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cellular Immune Augmentation in Colon and Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chemo Therapy and GM-CSF n=20 Participants Granulocyte-Macrophage Colony-Stimulating Factor
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=39 Participants
Age, Categorical >=65 years	9 Participants n=39 Participants
Age, Continuous	62.65 years STANDARD_DEVIATION 13.52 • n=39 Participants
Sex: Female, Male Female	11 Participants n=39 Participants
Sex: Female, Male Male	9 Participants n=39 Participants
Region of Enrollment United States	20 participants n=39 Participants

PRIMARY outcome

Timeframe: 24 Months

Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer.

Outcome measures

Outcome measures
Measure	Chemo Therapy and GM-CSF n=16 Participants Granulocyte-Macrophage Colony-Stimulating Factor
Participants Exhibiting Immune Response	11 Participants

SECONDARY outcome

Timeframe: 24 Months

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.

Outcome measures

Outcome measures
Measure	Chemo Therapy and GM-CSF n=16 Participants Granulocyte-Macrophage Colony-Stimulating Factor
Response Rates and Overall Survival. Response Rates	16 Participants
Response Rates and Overall Survival. Overall Survival	16 Participants

Adverse Events

Chemo Therapy and GM-CSF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chao Family Comprehensive Cancer Center

University of California, Irvine

Phone: (877) 827-8839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place