This trial is active, not recruiting.

Conditions metastatic colon cancer, metastatic rectal cancer
Treatment gm-csf
Phase phase 2
Sponsor University of California, Irvine
Start date April 2003
End date December 2008
Trial size 40 participants
Trial identifier NCT00257322, UCI 02-60


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 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Define immunological dendritic cell & cellular immune responses
time frame: 5 years

Secondary Outcomes

Define the effect of cellular immune stimulation on response rates and overall survival.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy
Principal investigator Randall Holcombe, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2008.
Information provided to ClinicalTrials.gov by University of California, Irvine.