drugset / Trial / NCT00257322

Cellular Immune Augmentation in Colon and Rectal Cancer

NCT00257322 ↗

Phase 2 Completed 20 enrolled University of California, Irvine
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2003-04
Primary completion
2007-01
Completion
2007-01

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-CSF Protein / enzyme biologic 250 ug/m2 Subcutaneous