Cellular Immune Augmentation in Colon and Rectal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/2/2018 |
| Start Date: | April 2003 |
| End Date: | January 2007 |
A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy
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.
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.
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
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