Cellular Immune Augmentation in Colon and Rectal Cancer

Completed · Phase 2

Conditions studied: Colon Cancer, Rectal Cancer

In brief

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.

Key facts

Study ID

NCT00257322

Run by

University of California, Irvine

People needed

20

Starts

2003-04-01

Expected to finish

2007-01-01

Last updated by the study team

2018-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known allergic or other adverse reaction to GM-CSF
• Chemotherapy administration more frequently than bi-weekly
• Pregnant or lactating women

Where it is running

• Chao Family Comprehensive Cancer Center — Orange, California, United States

Full record on ClinicalTrials.gov

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