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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00257322
Other study ID # UCI 02-60
Secondary ID 2003-2876
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2003
Est. completion date January 2007

Study information

Verified date February 2018
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient must have: metastatic, disseminated or recurrent colon or rectal cancer

- Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly

- Patient must be able to be taught to administer GM-CSF subcutaneously

Exclusion criteria:

- Known allergic or other adverse reaction to GM-CSF

- Chemotherapy administration more frequently than bi-weekly

- Pregnant or lactating women

Study Design


Intervention

Drug:
GM-CSF
250ug/m^2 SQ QD with a cap of 500mcg SQ QD

Locations

Country Name City State
United States Chao Family Comprehensive Cancer Center Orange California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants Exhibiting Immune Response Immunological dendritic cell and cellular immune responses to GM-CSF administered in conjunction with chemotherapy for patients with advanced colorectal cancer. 24 Months
Secondary Response Rates and Overall Survival. 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. 24 Months
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