Cellular Immune Augmentation in Colon and Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

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