NCT00257322

Cellular Immune Augmentation in Colon and Rectal Cancer

A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	GM-CSF	250ug/m\^2 SQ QD with a cap of 500mcg SQ QD

Timeline

• Start date: 2003-04-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-11-22
• Last updated: 2018-10-31
• Results posted: 2016-04-26

Locations

1 site across 1 country: United States